(210 days)
The enlightenVue Microendoscopy System is intended for visualization of body cavities, hollow organs, and canals. The surgiVue microendoscope is designed to be introduced through natural body cavities or surgical incisions through introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter of the microendoscope.
The enlightenVue Microendoscopy System is comprised of the surgiVue microendoscope and surgiTrac laser light source. This system is used to provide imaging capability of internal anatomy for both diagnostic and interventional procedures. The small laser light source focuses light onto a small fiber in the form of white light. The surgiTrac interfaces with the disposable surgiVue microendoscope and a PC to allow for illumination of the captured image.
The provided document is a 510(k) summary for the enlightenVue Microendoscopy System. It focuses on demonstrating substantial equivalence to a predicate device rather than outlining detailed acceptance criteria for an AI/ML-driven medical device and a study proving it meets those criteria.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria for an AI/ML device and a study proving device performance against those criteria. The provided text is for a traditional medical device (endoscopy system) and relies on functional, mechanical, and biocompatibility testing for substantial equivalence, not AI/ML performance metrics.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No AI/ML Component: The enlightenVue Microendoscopy System is described as a system for visualization using a microendoscope, light source, and camera. There is no mention of artificial intelligence, machine learning, image processing algorithms for diagnostic aid, or similar features that would necessitate AI-specific acceptance criteria.
- Performance Metrics are for Device Functionality, Not AI Accuracy: The "Performance Testing" section (page 6-7) lists tests like "Accelerated Aging," "Real-Time Aging," "Cytotoxicity Test," "Dimensional Verification," "Electrical Characteristics," and "Functional Verification: surgiVue Microendoscope." These are standard tests for endoscopes to ensure their physical and functional integrity, not for evaluating the performance of an AI algorithm (e.g., sensitivity, specificity, AUC).
- No "Ground Truth" for AI/ML: Since there's no AI component, there's no need for establishing ground truth from expert consensus, pathology, or outcomes data, which are crucial for validating AI models.
- No Test Set/Training Set Sizes: Similarly, the concepts of training and test sets are absent because there's no AI model being developed or validated.
- No Multi-Reader Multi-Case (MRMC) Study: MRMC studies are used to assess how AI impacts human reader performance, which isn't applicable here.
- No Standalone Performance: Standalone performance refers to the AI algorithm's performance without human intervention, which is not relevant to this device.
In summary, the provided document describes information relevant to a traditional medical device K-clearance, not an AI/ML-powered device. Therefore, a table of acceptance criteria for an AI/ML device and details of a study proving its performance against those criteria cannot be extracted.
§ 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.