(62 days)
EG-530N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The EG-530N can be inserted orally or transnasally.
FUJIFILM Endoscope Model EG-530N is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
This document describes the FUJIFILM Endoscope Model EG-530N. However, the provided text does not contain information about a study proving that the device meets acceptance criteria related to an AI or algorithm's performance. The document is a 510(k) summary for a medical endoscope, focusing on its mechanical and electrical safety, biocompatibility, reprocessing validation, and basic performance characteristics (field of view, bending capability, etc.).
It does not mention:
- Any AI component or algorithm.
- Software performance criteria based on diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI.
- Studies involving human readers with or without AI assistance (MRMC studies).
- Any ground truth establishment by experts for diagnostic purposes.
- Training or test set sample sizes for an algorithm.
The "Performance Data" section refers to engineering and safety tests for the endoscope itself, not an AI or diagnostic algorithm.
Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria for an AI-driven device, the study proving it, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, or ground truth establishment relevant to AI.
The acceptance criteria mentioned in the document are for the physical endoscope's performance, such as:
- Field of view
- Bending capability
- Rate of air supply
- Rate of water supply
- Suction rate
- Working length
- Forceps channel diameter
- Viewing direction
- Resolution
- LG output (presumably "Light Guide output" or similar)
The document states: "In all cases, the devices met the pre-defined acceptance criteria for the test." However, it does not provide the specific numerical acceptance criteria or the detailed results for each of these physical parameters.
In summary, your request seems to be looking for information about an AI/algorithm-driven device, but the provided documentation is for a traditional medical endoscope, which does not appear to incorporate AI or machine learning.
§ 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.