(90 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is mentioned.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
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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.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.