NeuroSync ERP
NeuroSync ERP™ · IS360 Technologies & Services Pvt. Ltd.
SLDA/PAZ Engine v4.1 · SaMD Class B · CDSCO · ICMR Guidelines
🔒 HIPAA · DPDP Act 2023 — Data Handling Notice
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Tier 2 — Restricted Access
Analysis + Prediction requires MD, OT, or LAB role.
MDOTLABSA
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NeuroSync ERP™
Tier 2 · Analysis + Prediction · Cognitive Analysis · SaMD-Grade Accuracy Metrics
Tier 2 · Page 1 of 3
— · 03 Nov 2025
⚠ RESEARCH ANALYSIS — TIER 2 — FOR CLINICAL / RESEARCH USE ONLY — Not a standalone diagnosis
3D Anatomical Brain Views — Labelled Regions · EEG Source Localisation Reference FIG. 10–14
1. Sagittal View · Midline
Corpus Callosum · Thalamus · Brainstem
3D Sagittal
2. Axial View · Top Slice
EEG mapping O1 O2 Oz · Symmetry
3D Axial
3. Coronal View · Front
Hippocampus · Lateral Ventricle · Thalamus
3D Coronal
4. Lateral View · Side
Frontal · Parietal · Temporal · Occipital
3D Lateral
5. Superior View · Top
10-20 montage · Longitudinal fissure
3D Superior
Cognitive Analysis — SaMD-Grade Accuracy Metrics · Confidence Intervals · SLDA Inference CLINICAL DECISION SUPPORT
⚕ SaMD Research-Grade Classification Statement
NeuroSync ERP™ is classified as a Software as a Medical Device (SaMD) — Research Grade under CDSCO guidelines. The following cognitive metrics are generated by the SLDA/PAZ v4.1 engine and represent AI-assisted clinical decision support. All values must be reviewed by a qualified neurologist / neonatologist before clinical action. Sensitivity and specificity values are derived from the IS360 validation dataset (n=247, mixed paediatric cohort, 2023–2025).
Classification Confidence
97.3%
ERP/P300 classification
95% CI: [94.1%, 99.2%]
SLDA Sensitivity
94.8%
ERP paradigm detection
95% CI: [91.2%, 97.4%] · n=247
SLDA Specificity
96.2%
True negative rate
95% CI: [93.1%, 98.3%] · n=247
PAZ Ambiguity
0.0%
Zero-PAZ — STABLE
0/19 samples in ambiguity zone
Asymmetry Index (AI)
Right > Left (F4-C4)
Clinical threshold: >30% = abnormal
KSI Stability
1.000
Maximum stability index
Range: 0–1 · 1.0 = fully stable
Auditory Cortex Integrity
Impaired?
Right STG activation reduced
ABR required to confirm
Cognitive Risk Score
Moderate
Language domain primary
S_lang flag: auditory delay risk
Cognitive DomainSTEM Score (Band A)StatusInference (AI)Clinical ActionConfidence
Language / Auditory (S_lang)Pending ABRAT RISKRight temporal delta excess suggests auditory cortex hyper-excitability. N1/P1 latency likely prolonged.ABR bilateral · Auditory stimulation programme82% (pre-ABR)
Attention (S_att)θ/α = 6.014Normalθ/α ratio within Band A neonatal norms. Frontal theta present. Early attention network intact.Monitor at Band B (18mo+)89%
Motor / SomatosensoryF4-C4: —MonitorRight fronto-central delta excess (—%) indicates asymmetric motor cortex activation. Right stiffness observed clinically.IRT — right limb stimulation · PT referral91%
Visual-Spatial (S_vis)α-occ = 1,157NormalOccipital alpha immature (1,157 µV²/Hz) — age-appropriate for 6 months. Visual cortex developing normally.Visual tracking exercises85%
Processing Speed (S_ps)ERP latency TBDPendingERP latency requires active paradigm (ABR). SLDA kernel: P1/N1 latency inference blocked pending auditory evaluation.ABR will resolve76%
Brain Activation Map — Cognitive Domain Overlay · Signal Dominant Areas FIG. 15
Cognitive Domain Map · Animated · Band A (0–18 months) Overlay
LANGUAGE / AUDITORY AT RISK · ABR pending MOTOR CORTEX F4-C4 excess · MONITOR ATTENTION NORMAL VISUAL Normal F4 C4 * Animation speed ∝ signal intensity · Red = excess · Amber = at risk · Cyan = normal
SLDA Classification · PAZ Geometry · Confidence Matrix
Paradigm Probability Distribution
ERP / P30034.5%
ALZ Pattern*28.5%
Motor Imagery19.6%
Epilepsy10.3%
PAZ = {x : Δ P(Cᵢ|x) ≤ 0.15} · ε = 0.15
PAZ Ratio: 0.0% · Stable: 19/19
KSI: 1.000 · L₀₁ ≈ 1.60 · L₀₂ ≈ 1.20
Classification: ERP/P300 STABLE
*ALZ class not applicable at 6 months — adult kernel only
NPSP Band Assignment — Age-Normalised Protocol Mapping BAND A ACTIVE
BandAgeRecording TypeStimuli ProtocolERP TargetsSTEM Focus
A ▶ ACTIVE
Subject
0–18 moPassive ERPAuditory click trains 500Hz 70dB; MMN oddball 1000/1500Hz; visual checkerboard 1HzP1/N1; MMN; cABRAuditory integrity; early language
B Toddler18mo–4yrGamified oddballVisual cartoon targets; animal sounds; touch-screen matchP300; N200; LPCAttention; visual speed
C Childhood4–8 yrActive TEEPArithmetic; phoneme; spatial rotation; readingP300; N400; theta; P600Reading; numeracy; attention
D Adolescent8–18 yrFull STEM batteryFull NCSB: P300; N400; arithmetic ERP; rotation 3DAll 6 STEM scoresFull STEM profiling
E Geriatric18–99 yrCognitive screenP300; N400; MMN; resting EEG; SSVEP; motor imageryP300 lat; ALZ-score; PAZ driftMemory; ALZ/MCI prediction
Longitudinal Prediction Roadmap — SLDA/PAZ Serial Tracking
NOW
03 Nov 2025
Baseline EEG
PAZ — · —
+3 mo
Feb 2026
EEG + ABR
PAZ drift check
+6 mo
May 2026
Full EEG
Asymmetry trend
12 mo
Nov 2026
Band A→B
Alpha emergence
24 mo
Nov 2027
NPSP Band B
STEM profiling
Report Date
29 March 2026
Recording: 03 Nov 2025
Reporting Clinician
Mr. P.S. Iyngar
IS360 Technologies · NeuroSync ERP™
Authorised Signature
Reviewing Clinician
Dr. Shakila Kulasekaran
Neonatologist · Sri Gokulam Hospital
Authorised Signature
Tier & Access
Tier 2 · Analysis + Prediction
RBAC: MD / OT / LAB / SA
SaMD Class B · CDSCO · HIPAA
⚠ RESEARCH ANALYSIS ONLY — NOT A STANDALONE MEDICAL DIAGNOSIS. Cognitive confidence intervals derived from IS360 validation dataset (n=247). All AI-generated inferences require physician review before clinical action. NeuroSync ERP™ is a SaMD Class B device regulated under CDSCO and ICMR guidelines (India). Data protected under HIPAA and India's DPDP Act 2023. This report is confidential and intended solely for the named clinician.
Tier 2 — Analysis + Prediction · Disclaimer
Cognitive confidence intervals derived from IS360 validation dataset (n=247). SaMD research-grade — all AI inferences require physician review. For Full IRT Intervention Plan — Tier 3 (MD/SA) required. NeuroSync ERP™ © 2026 IS360 Technologies & Services Pvt. Ltd. All rights reserved.
Audit
1 · EEG Upload
EDF / Subject File
2 · Algorithm
SLDA-v4.1-IS360
v4.1 · IS360
3 · Clinician
Confirmed · IS360
4 · Sealed
Block #4
SHA-256 · Immutable
⛓ Block #4 · SLDA-v4.1-IS360
Computing…
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Tier 3 — MD / SA Only
Full IRT Intervention Plan is restricted to Physician (MD) and System Administrator (SA) roles.
MD — PhysicianSA — System Administrator
NeuroSync ERP™ · Tier 3 · IRT Plan
Full IRT Plan —
Physiotherapy · Occupational Therapy · Home Programme · Referral Schedule
TIER 3 · MD/SA ONLY
⚠ TIER 3 — FOR CLINICAL USE — IRT plan from EEG-SLDA findings. Physiotherapist must co-assess before implementation.
MRI Reference — Anatomical Basis for IRT Intervention Targeting ALL 5 VIEWS
Axial · F4-C4 Zone
Right fronto-central excess · Motor target
Axial MRI
Sagittal · Midline
Corpus callosum integrity · IRT basis
Sagittal MRI
Coronal · Subcortical
Hippocampus · Thalamus · plasticity zones
Coronal MRI
Lateral · Lobe Targets
Frontal · Temporal (STG) · IRT zones
Lateral MRI
Superior · Electrode Heatmap
All 19 channels · Δ power · IRT priority
Superior MRI
EEG-to-Anatomy Mapping — IRT Activity Plan
Motor / Somatosensory — F4-C4
Right Limb Targeted Stimulation
Gentle passive ROM right upper/lower limb. Wilbarger brushing protocol. Prone positioning to activate bilateral motor cortex. Warm compress before PT if stiffness noted.
Daily × 10 min · AM + PM · Caregiver-guided
Auditory / Sensory — STG/HG Temporal
Structured Auditory Stimulation
Parent-voiced narration 15 min/day. Varied acoustic environments. ABR-guided intensity post-referral. AIT if ABR confirms delay.
Daily × 15 min · Multiple sessions
Language / Visual — Occipital
Visual Tracking & Language Foundation
High-contrast black-white cards at 30 cm. Slow moving objects tracking. Baby sign language introduction. Sound-object pairing for early language network.
Twice weekly × 20 min · Home 5 min daily
Global Regulation — Sleep / Arousal
Sleep Hygiene & Arousal Protocol
Consistent sleep routine. Dim lighting 1 hour before sleep. Kangaroo care for autonomic regulation. No over-stimulation within 30 min of nap.
Daily — integrated into routine
Physiotherapy Priority Matrix FOR PHYSIOTHERAPIST USE
EEG ZoneFindingPriorityPT/OT TechniqueDosageMilestoneReview
F4-C4 Right— Δ excessHIGHPassive ROM right limb; Wilbarger; prone facilitation10 min BIDSymmetric tone by 9 mo4 weeks
STG/HG TemporalAuditory pathway — primary indicationHIGHABR-guided acoustic therapy; parent narration; AIT15 min dailyStartle/orienting by 8 moPost-ABR
Frontal MidlineTheta/Alpha 6.014 (normal)MODJoint attention; parent-infant interaction; music therapy20 min 3×/wkSocial smile by 7 mo8 weeks
Occipital V1Alpha immature 1,157 µV²/HzMODHigh-contrast visual cards; moving target tracking5 min 2× dailyVisual pursuit by 8 mo8 weeks
Global Regulationδ/θ — drowsy stateMONITORSleep hygiene; kangaroo care; consistent routineDaily integrationAlert periods for next EEG3 months
Daily Home Programme Card PRINT & DISPLAY
🏠 — Daily Home Programme
Morning · 9–9:15 AM
Right limb gentle massage & stretching
10 min · Warm compress first
Morning · 10–10:15 AM
Talk & narrate — describe surroundings
15 min · Varied tone and pace
Midday · After feed
Tummy time on firm surface
5–10 min × 2 · Motor strength
Afternoon · 3 PM
Visual tracking — high-contrast card
5 min · 30 cm from face
Evening · 6–6:15 PM
Music / singing / auditory stimulation
15 min · Mother tongue songs
Evening · 7–7:10 PM
Right limb massage (second session)
10 min · Gentle circular strokes
Bedtime routine
Dim lights · Quiet · Kangaroo care
30 min before sleep · Consistent
All day
Respond immediately to all vocalisations
Builds auditory feedback loop
Platform
NeuroSync ERP™ v4.1
Tier 3 · Full IRT · SaMD Class B
CDSCO · ICMR · HIPAA · DPDP 2023
Platform Signature
Reporting Clinician
Mr. P.S. Iyngar
IS360 Technologies · NeuroSync ERP™
Authorised Signature
Reviewing Neonatologist
Dr. Shakila Kulasekaran
Neonatologist · Sri Gokulam Hospital
Authorised Signature
Physiotherapist Co-sign
_________________________
PT co-sign MANDATORY before implementation
Therapist Signature + Date
⚠ RESEARCH ANALYSIS ONLY — NOT A STANDALONE MEDICAL DIAGNOSIS. This Tier 3 IRT Intervention Plan is AI-generated from EEG-SLDA data. All therapy prescriptions must be co-reviewed and co-signed by a qualified physiotherapist prior to implementation. NeuroSync ERP™ is a SaMD Class B regulated under CDSCO and ICMR guidelines. Data protected under HIPAA and India's DPDP Act 2023. For MD / SA access only — confidential.
Tier 3 — Full IRT Intervention · Disclaimer
This Tier 3 IRT Plan is generated by NeuroSync ERP™ AI engine. All therapy must be reviewed and co-signed by a qualified physiotherapist before implementation. Not a standalone clinical prescription. MD/SA roles only. IS360 Technologies & Services Pvt. Ltd. © 2026 · DPDP/ICMR compliant. All rights reserved.
Audit
1 · EEG Upload
EDF / Subject File
2 · Algorithm
SLDA-v4.1-IS360
v4.1 · IS360
3 · Clinician
Confirmed · IS360
4 · PT Co-sign
Physiotherapist
Required · Tier 3
⛓ Block #4 · SLDA-v4.1-IS360
Computing…