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The Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.

The Intuitive Surgical® Stereo View System consists of an endoscope, camera, and light source. The endoscope is essentially identical in size and shape to the predicate devices referenced above, but built by a different manufacturer. This endoscope has 3 channels allowing the surgeon to alternate between a stereo three-dimensional view and a wide angle two-dimensional view using a simple video switch that can be used to toggle between the two images. This switch is located between the camera and the Intuitive Surgical® Endoscopic Instrument Control System, on a vision system cart that includes the illumination sources, camera controllers and other video processing equipment. The camera controllers and illumination sources that attach to the endoscope and camera are identical in function to those described for the predicate devices.

The provided 510(k) summary for the Intuitive Surgical® Stereo View Endoscopic System does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical testing comparable to what would be found in an AI/ML device submission.

This document describes a device that is essentially a 3-D endoscope and its accessories, and its clearance is based on substantial equivalence to previously marketed predicate devices (K990188 and K001666). The performance evaluation focuses on design analysis, comparison to predicate devices, material biocompatibility, and compliance with electrical safety standards, rather than a clinical performance study with specific acceptance criteria.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study details cannot be extracted from this particular 510(k) summary.

Here's a breakdown of why each point cannot be appropriately answered based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: No specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for an AI algorithm) are stated for the device's clinical performance. The focus is on substantial equivalence to existing devices and compliance with technical standards.
   • Reported Device Performance: The document states "Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate device cited." It also mentions compliance with electrical safety and biocompatibility standards. These are not performance metrics in the sense of an AI/ML diagnostic output.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of device submission. There is no "test set" of images or data being analyzed by an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment for a test set in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device, so no MRMC study or AI improvement metrics are discussed. The device is an endoscopic system providing a view to the surgeon.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of diagnostic accuracy for an AI is not relevant here.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

Summary of available information related to "performance":

The "Performance Data" section primarily addresses:

• Design Analysis and Comparison: Functional characteristics are "substantially equivalent" to predicate devices.
• Material Biocompatibility: Materials are identical to those in the predicate device, with a "long history of human contact bio-compatibility," and consistent with ISO 10993.
• Electrical Safety: Electrical components tested for compliance with UL 2601-1, CSA C22.2 No 601.1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and EN 55011, as well as relevant provisions of the European Medical Device Directive 93/42/EEC.

Conclusion from the document:
Based on the submitted information, the device is considered "substantially equivalent" to legally marketed predicate devices, implying it meets the same level of safety and effectiveness as those devices through its design, materials, and compliance with relevant standards.

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