(29 days)
These devices are intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM Endoscope Models EC-600HL and EC-600LS are lower gastrointestinal endoscopes that capture 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 endoscopes, 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.
This document describes the 510(k) premarket notification for the FUJIFILM Endoscope Models EC-600HL and EC-600LS. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K162622). As such, the study performed is a performance testing of the device itself rather than a study on an AI algorithm. Therefore, many of the typical questions for AI/ML study design (e.g., sample size for test/training sets, data provenance, ground truth establishment, MRMC studies) are not applicable in this context.
Here's an analysis of the provided information concerning the device's performance and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "In all cases, the devices met the pre-defined acceptance criteria for the test." However, the exact quantitative acceptance criteria for each test are not explicitly provided in the submitted text. The performance data section lists the parameters tested, but not the specific thresholds for acceptance.
| Performance Parameter | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Field of view | Not explicitly stated | Met pre-defined acceptance criteria |
| Bending capability | Not explicitly stated | Met pre-defined acceptance criteria |
| Air supply rate | Not explicitly stated | Met pre-defined acceptance criteria |
| Water supply rate | Not explicitly stated | Met pre-defined acceptance criteria |
| Suction rate | Not explicitly stated | Met pre-defined acceptance criteria |
| Working length | Not explicitly stated | Met pre-defined acceptance criteria |
| Forceps channel diameter | Not explicitly stated | Met pre-defined acceptance criteria |
| Viewing direction | Not explicitly stated | Met pre-defined acceptance criteria |
| Resolution | Not explicitly stated | Met pre-defined acceptance criteria |
| LG output (Light Guide output) | Not explicitly stated | Met pre-defined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
This is a physical device performance test rather than an AI/ML algorithm evaluation. The document does not specify the sample size of devices used for testing. It also does not specify data provenance as it's not a data-driven AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The performance testing is for physical device characteristics, not for diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as this is not an AI/ML study requiring expert adjudication of results.
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
No. This is a performance evaluation of a physical endoscope, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This approval is for an endoscope as a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" here would be the physical and functional specifications of the endoscope. For example, for "Field of view," the ground truth would be the expected angular range, and the device's measurement would need to fall within the accepted tolerance of that specification. The document implies these are established engineering specifications rather than clinical ground truth (e.g., pathology).
8. The sample size for the training set
Not applicable. There is no AI model or training set involved in this device approval.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved. The ground truth for this device's performance would be engineering and design specifications.
§ 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.