CLINICAL VALIDATION · IEC APPROVAL · ACADEMIC CREDENTIALS

Clinical Validation & Institutional Evidence.

Official public evidentiary repository for QuaasX108 Private Limited — housing our Institutional Ethics Committee (IEC) approval, Phase-1 AI-Robotic Surgery in Ayurveda clinical validation instruments for ShalyaMitra (Nael — the Achiever) under Protocol QUAASX/TMAE/IEC/2026/001, and official Certificates of Appreciation from RGUHS-affiliated Ayurvedic medical colleges.

IEC PROTOCOL
IEC/2026/001
3-Year Statutory Validity
CLINICAL TRIAL SITE
T.M.A.E. Hosapete
Dept. of Shalyatantra (Code A-252)
ACADEMIC SEMINAR
PAMCH Chitradurga
NCISM Code: AYU0853 · RGUHS
PUBLIC ARCHIVE
6 Official Files
3 Clinical PDFs · 3 Signed Scans
SHALYAMITRA PHASE-1 CLINICAL VALIDATION INSTRUMENTS

Clinical Trial Validation Certificates & Observer Handbook

Official regulatory and peer-observation instruments for World's First AI-Robotic Surgery in Ayurveda — Phase 1 (Protocol QUAASX/TMAE/IEC/2026/001 & QUAASX/TMAE/VAL/2026/001), aligned with ICMR, NDCT 2019, ICH-GCP E6(R2), CDSCO SaMD, and Ministry of AYUSH guidelines.

Public Path: /validation/*.pdf
IEC / CDSCO SaMD Evidentiary FormQUAASX/TMAE/IEC/2026/001 — FORM A9 Pages (4-Section Evidentiary Dossier)
Original File: DOC-20260421-WA0000. (1).pdf

Live Remote Observer Validation & Witnessing Certificate

World's First AI-Robotic Surgery in Ayurveda — Phase 1 (Pilot Feasibility)
PROTOCOL REFERENCE
QUAASX/TMAE/IEC/2026/001
VERSION & RELEASE
Version 1.0 · April 2026
CLINICAL SITE
Dept. of Shalyatantra, T.M.A.E. Society's Ayurvedic Medical College & Hospital, Hosapete, Karnataka

Formal evidentiary witnessing instrument completed by 20–30 independent medical professionals (BAMS, MBBS, MS, MD) observing live surgical procedures featuring ShalyaMitra and its primary surgical intelligence agent, Nael — the Achiever.

Section A: Observer Identification, Medical Council Registration & Live Stream Telemetry
Section B: 26-Point Clinical Observation Checklist (Nael Voice Responsiveness, Monitor/Overhead/Haemorrhage Sentinels, Surgical Safety & Protocol Compliance)
Section C & D: 10-Parameter Quantitative Rating Matrix (1–5 Scale) & Independent Professional Validation Narrative
Section E & F: Formal Regulatory Submission Consent for IEC, CDSCO (SaMD), Ministry of AYUSH & Indian Patent Office
LIVE DOCUMENT PREVIEW — Live Remote Observer Validation & Witnessing CertificateFullscreen PDF ↗
In-Person Peer AttestationQUAASX/TMAE/VAL/2026/0014 Pages (In-Person OT / Viewing Gallery Record)
Original File: DOC-20260710-WA0001..pdf

In-Person Expert Observation & Attestation Record

Supplementary Peer-Observation Instrument to the IEC-Approved Clinical Protocol
PROTOCOL REFERENCE
QUAASX/TMAE/IEC/2026/001 · Instrument QUAASX/TMAE/VAL/2026/001
VERSION & RELEASE
Version 1.0 · 21 April 2026
CLINICAL SITE
T.M.A.E. Ayurvedic Medical College & Hospital, Hosapete & Live Observation Venue (Mumbai, Maharashtra)

Structured in-person peer-observation and attestation record for independent Ayurveda scholars and surgical specialists physically present during live ShalyaMitra operative sessions, countersigned by Principal Investigator Dr. M. D. Samudri.

Part A & B: Independent Observer Credentials, Declaration of Non-Compensation & De-Identified Session Metadata
Part C: Direct Verification of Zero Physical Contact, Classical Shalyatantra Adherence & Non-Binding Advisory Operation
Part D: Scope-Limited Independent Peer Remarks for Institutional Master File Inclusion
Part E: Formal Dual Attestation with Principal Investigator Countersignature (Dr. M. D. Samudri, MS Ayurveda)
LIVE DOCUMENT PREVIEW — In-Person Expert Observation & Attestation RecordFullscreen PDF ↗
15-Page Clinical CompendiumHANDBOOK — IEC/2026/001 & VAL/2026/00115 Pages (Clause Matrix & Discipline Templates)
Original File: DOC-20260710-WA0004..pdf

Clinical Observer Validation Handbook & Reference Compendium

Structured Linguistic Frameworks & Reference Clauses for ShalyaMitra (v3.0) Peer Review
PROTOCOL REFERENCE
QUAASX/TMAE/IEC/2026/001 & QUAASX/TMAE/VAL/2026/001
VERSION & RELEASE
v3.0 Compendium · 2026
CLINICAL SITE
Department of Shalyatantra, T.M.A.E. Ayurvedic Medical College & Hospital, Hosapete, Vijayanagara District

Comprehensive 15-page reference compendium assisting independent Ayurveda scholars, allopathic surgeons, and anaesthesiologists in formulating legally defensible, ICH-GCP and CDSCO SaMD-compliant narrative assessments.

Cross-Referenced Clause Library (Clauses D1-A1 to D4-B2) covering Voice Wake-Word Latency, Multi-Sentinel OCR & Sushruta Samhita Shloka Mapping
Marma Vigyana Proximity Alert Verification & Non-Interventional Software-as-a-Medical-Device (SaMD) Safety Framing
Turnkey Specialization Templates for Shalyatantra Specialists, General Surgeons (MBBS/MS) & Anaesthesiologists
Tiered Evaluation Rubrics & Regulatory Submission Compliance Matrix for IEC, Ministry of AYUSH & CDSCO
LIVE DOCUMENT PREVIEW — Clinical Observer Validation Handbook & Reference CompendiumFullscreen PDF ↗
REGULATORY & ETHICAL GOVERNANCE

Passive, Non-Interventional Decision Support — Human Surgeon Autonomy First

Across all Phase-1 clinical evaluations under Protocol QUAASX/TMAE/IEC/2026/001, ShalyaMitra and its primary operative agent Nael — the Achiever operate strictly as a non-contact, software-only decision-support system outside the sterile perimeter. All operative actions and clinical decisions remain 100% under the authority of the qualified BAMS MS surgeon and Institutional Ethics Committee oversight.