(88 days)
This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Duodenoscope Model ED-580XT 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 portion 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.
Based on the provided text, the document describes the substantial equivalence of the FUJIFILM Duodenoscope Model ED-580XT, not a study evaluating an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, are not present in this document.
The document mainly focuses on the physical and functional aspects of the duodenoscope and its safety and performance standards.
Here's a breakdown of what can be extracted, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists performance specifications that were tested and states the device met the "pre-defined acceptance criteria for the test." However, the specific numerical or descriptive acceptance criteria themselves are not provided, nor are the reported raw performance values.
| Performance Characteristic | Acceptance Criteria (Not Specified) | Reported Device Performance |
|---|---|---|
| Electromagnetic compatibility | IEC 60601-1-2:2014 standards | Met all standards |
| Biocompatibility | ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010; FDA guidance "Use of International Standard ISO 10993-1..." | Met all standards and guidance |
| Sterilization | AAMI TIR12:2010, AAMI TIR30:2011; FDA guidance "Reprocessing Medical Devices in Health Care Settings..." | Met all standards and guidance |
| Field of view | Not specified | Met pre-defined acceptance criteria |
| Bending capability | Not specified | Met pre-defined acceptance criteria |
| Rate of air supply | Not specified | Met pre-defined acceptance criteria |
| Rate of water supply | Not specified | Met pre-defined acceptance criteria |
| Rate of suction | Not specified | Met pre-defined acceptance criteria |
| Working length | Not specified | Met pre-defined acceptance criteria |
| Forceps standing angle | Not specified | Met pre-defined acceptance criteria |
| Forceps standing tension | Not specified | Met pre-defined acceptance criteria |
| Diameter of forceps channel | Not specified | Met pre-defined acceptance criteria |
| Viewing direction | Not specified | Met pre-defined acceptance criteria |
| Resolution | Not specified | Met pre-defined acceptance criteria |
| LG output | Not specified | Met pre-defined acceptance criteria |
Information NOT available in the document:
- Sample sizes used for the test set and the data provenance: Not applicable as this is not an AI/ML study with a "test set" in that context. The "tests" refer to engineering performance validations.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not established for this type of device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a medical device (a duodenoscope) and details its engineering performance, biocompatibility, and sterilization, rather than the clinical performance of an AI/ML-powered diagnostic 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.