(71 days)
The Intuitive Surgical™ Stereo View Endoscopic System is intended for endoscopic vicwing of internal surgical sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed to be used with the Intuitive Surgical™ Endoscopic Instrument Control System during thoracoscopic and laparoscopic surgical procedures
The Intuitive Surgical™ Stereo View System consists of an Intuitive Surgical endoscope, an Intuitive Surgical camera, and a commercially available light source. The endoscope is essentially identical in size and shape to the predicate devices referenced above, with minor modifications so that it can be attached to the Intuitive Surgical™ Endoscopic Instrument Control System. The camera and illumination sources attach to the endoscope and are essentially identical in function to those incorporated with the predicate Olympus System.
The provided text does not contain information about specific acceptance criteria or a detailed study proving the device meets them. Instead, it is a 510(k) summary for a medical device (Intuitive Surgical™ Stereo View Endoscopic System) seeking substantial equivalence to predicate devices.
The document indicates that the device's approval is based on a comparison to existing devices rather than a performance study against specific acceptance criteria.
Here's an analysis of the provided information based on your requested points, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not define specific acceptance criteria (e.g., in terms of resolution, field of view, illumination intensity, or accuracy metrics) or provide a table reporting the device's performance against such criteria. The submission is focused on demonstrating "substantial equivalence" to predicate devices rather than meeting pre-defined performance thresholds.
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 / Not present. The document states, "Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited." This indicates that the evaluation was likely based on engineering design analysis and direct comparison of specifications and functional descriptions, rather than a clinical "test set" of patient data or samples. Therefore, information on sample size, data provenance, retrospective/prospective nature is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not present. As there is no described test set involving clinical data or human evaluation to establish ground truth, this information is not relevant or provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not present. Since no test set or human evaluation for ground truth is described, there is no mention of an adjudication method.
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 present. This document predates widespread AI integration in medical devices and does not describe any MRMC study or AI assistance. The device is an endoscopic system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not present. This is not an AI algorithm. The device is a physical endoscopic system; therefore, a standalone algorithm performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not present. The submission relies on "Design analysis and comparison" to predicate devices, not on establishing ground truth for diagnostic accuracy. The substantial equivalence argument is based on the device's physical and functional characteristics being similar to already approved devices.
8. The sample size for the training set
- Not applicable / Not present. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable / Not present. As there is no training set for an AI model, this information is not relevant or provided.
Summary of the Study Proving Device Meets Acceptance Criteria (as described in the document):
The "study" or justification for approval is primarily a comparison to predicate devices. The document states:
- "Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."
- "The Intuitive Surgical™ Stereo View Endoscopic System endoscopes are essentially identical in terms of shape, size, materials, and function to the standard endoscopes cited. The stereo view feature of the camera is essentially identical to the 3D feature of the predicate Olympus System. The illumination source is identical to the one in the predicate Olympus system."
This means the device's acceptability is proven by demonstrating its similarity in design, materials, function, and intended use to devices already cleared for market, rather than through independent performance testing against pre-defined acceptance criteria. The FDA's clearance letter confirms "substantial equivalence."
§ 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.