(165 days)
The TIPCAM®1 Rubina Video Endoscope System is intended to be used together with the camera control unit during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological and urological anatomy.
The TIPCAM®1 Rubina video endoscope is an integrated unit that includes a camera and an endoscope. The endoscope receives the illumination light from the light source by the light guide connector connected to the light source device. The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end. The endoscope receives the reflected light from the inner lumen of a patient by the objective lens at the distal end. The built-in dual CMOS sensors convert the light to an electrical signal, and the signal is sent to the camera control unit (Image1 S Connect II + 4U-Link) via the attached cable for processing and display.
The provided text, a 510(k) summary for the TIPCAM®1 Rubina Video Endoscope System, does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled device.
The document describes a traditional 510(k) submission for an endoscope system, where the substantial equivalence to a predicate device (SPIES 3D System) is established through non-clinical performance data (bench testing) of the hardware components. The "Technological Characteristics" section mentions "two image viewing features: A 2D auto-leveling (autorotation) mode... and a 2D Auto-switch mode...", which are described as features of the subject device itself, not an external AI/ML system assisting it.
The non-clinical performance data section lists various tests like "Color Reproduction and Color Contrast Enhancement," "Distortion," "Depth of Field," "Spatial Resolution," etc., which are standard tests for video endoscope systems' optical and image quality. These are not acceptance criteria related to the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device and the study proving it meets those criteria based on this document. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications." This indicates that the device's clearance was based on hardware performance and established equivalence, not on the performance of an AI/ML component assessed via a clinical or reader study.
§ 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.