The arrival of table-integrated robots, live computer-vision copilots, and cloud-connected telemetry has transformed the surgical theater from an isolated procedural room into a mission-critical digital computing environment. To navigate this complexity, clinical engineering teams and surgical directors are adopting the 10-Point Surgical Intelligence Framework.

The 10 Evaluation Invariants

  1. Clinical Task Scope: Exact anatomical indication and boundary of software intervention.
  2. Control Hierarchy: Strict distinction between tele-operation, semi-autonomous guidance, and active bone cutting.
  3. Inference Latency: Sub-10ms glass-to-glass rendering on local edge accelerators (NVIDIA Holoscan).
  4. Fail-Safe Fallback Modes: Immediate mechanical disengagement in the event of software failure or tracking loss.
  5. Evidence & Provenance Logging: Cryptographically signed video and telemetry records for peer review and training.
  6. Regulatory Authorization: Verification of exact FDA De Novo or 510(k) cleared intended uses.
  7. Human-in-the-Loop Override: Mandatory surgeon confirmation for all procedural decisions.
  8. EHR & PACS Interoperability: Seamless DICOM image integration and automated operative report generation.
  9. Cybersecurity & Zero-Trust: Hospital network isolation preventing external telemetry tampering.
  10. Total Cost of Ownership: Evaluation of capital expenditure vs. consumable instrument per-procedure fees.
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Verified Primary Sources & Citations

Every empirical claim, economic metric, and technical assertion in this publication is cross-referenced against primary research literature and regulatory records: