(177 days)
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM 600 Series Endoscope EG-600WR v2 is an upper gastrointestinal endoscope that captures images when used in combination with a video processor and light source. Light travels from the light source, through the glass fiber bundles in the endoscope, and out the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor.
The provided text describes the Fujifilm 600 Series Endoscope EG-600WR v2, a medical device intended for the visualization and treatment of the upper digestive tract. It details a 510(k) premarket notification for this device, claiming substantial equivalence to a predicate device (Fujifilm 600 Series Endoscopes EC-600WL and EG-600WR, K132210).
However, the document does not contain information about an AI/ML-driven medical device, nor does it describe a study involving algorithms, human-in-the-loop performance, or reader studies with experts for ground truth establishment.
The provided text focuses on the endoscope device itself, and the modifications made to it. The performance testing outlined is for the physical device's characteristics (e.g., field of view, bending capability, resolution, safety, and reprocessing).
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device because the document describes a physical medical endoscope and not an AI/ML system.
If the request refers to the acceptance criteria for the physical endoscope, the available information is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "In all cases, the device met the pre-defined acceptance criteria for the test." However, the specific numerical acceptance criteria for each performance parameter are not explicitly listed in the provided text. Only the parameters tested are mentioned.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Field of view | Met pre-defined criteria |
| Bending capability | Met pre-defined criteria |
| Air supply rate | Met pre-defined criteria |
| Water supply rate | Met pre-defined criteria |
| Suction rate | Met pre-defined criteria |
| Working length | Met pre-defined criteria |
| Forceps channel diameter | Met pre-defined criteria |
| Viewing direction | Met pre-defined criteria |
| Resolution | Met pre-defined criteria |
| LG output (Light Guide Output) | Met pre-defined criteria |
| Electrical safety (ANSI/AAMI ES60601-1, etc.) | Compliant |
| Biocompatibility (ISO 10993) | Compliant |
| Endoscopic performance (ISO 8600-1) | Compliant |
| Cleaning, high-level disinfection, sterilization validation | Compliant |
| Storage and transportation validation | Compliant |
2. Sample sized used for the test set and the data provenance: Not applicable as this is a physical device and not a data-driven AI/ML system. The testing involved samples of the physical endoscope.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on image findings) is not relevant for the performance testing of a physical endoscope.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the physical device, performance was evaluated against technical specifications and consensus standards (e.g., ISO 8600-1 for endoscopic performance, IEC and ISO for safety and biocompatibility).
8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI/ML model.
§ 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.