(121 days)
The Digital Video Processor is designed to be used with Vathin medical endoscopes, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The Digital Video Processor is used in conjunction with Vathin endoscopes, and other accessories for endoscopic image processing during endoscopic diagnostic and therapeutic procedures. When used, it receives and processes image signals from a digital endoscope and transfers these signals to a connected monitor.
The provided text is a 510(k) Premarket Notification submission for a medical device called "Digital Video Processor" (K243117). It describes the device, its intended use, and compares it to a predicate device (Digital Video Monitor, K231135).
However, the document does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to a study proving the device meets these criteria in the context of an AI/algorithm-based device as requested in the prompt.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: This involves comparing features like trade name, classification, product code, regulation number, models, intended use, application field, intended user, max resolution, display type, USB connection, video output, and image/video capture.
- Summary of Non-clinical tests: This section lists general categories of testing performed, such as Electrical safety and electromagnetic compatibility (EMC), Software Verification and Validation Testing, and Performance testing (e.g., Field of view, Depth of field, Geometric distortion, Image intensity uniformity, Color performance).
There is no mention of:
- Specific acceptance criteria with quantitative thresholds.
- Reported device performance data against those thresholds.
- Details of a study involving AI/algorithm performance (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- How ground truth was established for training sets.
The "Digital Video Processor" appears to be a hardware component for processing endoscopic images, not an AI/algorithm-driven device itself that would require clinical performance studies for diagnostic accuracy. The performance tests listed are related to image quality and system functionality, not diagnostic performance.
Therefore, given the provided text, I cannot fulfill the request for a table of acceptance criteria and the study details as it pertains to an AI/algorithm-based device. The document clears a "Digital Video Processor" as an endoscope accessory, focusing on its functional equivalence, safety, and EMC, not a diagnostic AI tool.
§ 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.