(118 days)
The Arthrex NanoScope System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, and urology. The device is also intended to be used as an accessory for microscopic surgery.
For pediatric patients, the Arthrex NanoScope System is indicated for use in laparoscopy and orthopedic procedures.
The Arthrex NanoScope System provides real-time visible light illumination and imaging. The system includes a non-sterile reusable camera control unit (CCU) console and sterile disposable camera handpieces. The system integrates high-definition camera technology, LED lighting, and an imaging management system into a single console with touchscreen interface.
The provided document describes the Arthrex NanoScope System, a medical device used for endoscopic video imaging. However, this document does not contain information about a study proving the device meets specific acceptance criteria related to a specific performance metric (e.g., accuracy, sensitivity, specificity) for an AI/ML algorithm that identifies or classifies something.
The performance data section (pages 5 and 6) outlines various non-clinical bench testing, including:
- Biocompatibility testing: Performed according to ISO 10993 standards.
- Electrical, Mechanical, and Thermal (EMT) safety testing: Performed according to ANSI/AAMI ES60601-1 and IEC 60601-2-18 standards.
- Electromagnetic Compatibility (EMC) testing: Performed according to IEC 60601-1-2 standards.
- Software testing: Performed according to FDA guidance and IEC 62304.
- Design verification testing: Included inspection, engineering analysis, and functional testing.
These tests confirm the device's conformance to safety, performance, and software quality standards relevant to an endoscopic imaging system, rather than demonstrating the performance of an AI model against specific clinical metrics like sensitivity or specificity. The submission aims to expand indications and report software and device modifications, relying on equivalence to predicate devices rather than a de novo clinical study proving AI performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML algorithm's performance, as the provided text does not describe such a study. The document explicitly states: "The Arthrex NanoScope System did not require animal testing or human clinical studies to support the determination of substantial equivalence." This further indicates that no clinical performance study, particularly one involving AI/ML and human-in-the-loop or standalone performance, was conducted as part of this submission.
§ 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.