(55 days)
EC-760S-V/L is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM Endoscope Model EC-760S-V/L is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) 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 CMOS 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.
The provided text is a 510(k) Summary for the FUJIFILM Endoscope Model EC-760S-V/L. It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence.
Based on the information provided, here's an analysis of the acceptance criteria and study data:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "Fujifilm conducted the following performance testing on the proposed device EC-760S-V/L to ensure that the modified device performs equivalently to the predicate device:
- 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
In all cases, the device met the pre-defined acceptance criteria for the test."
However, the document does not provide the specific acceptance criteria values for each of these performance metrics, nor does it provide the measured performance values for the proposed device or the predicate device. It only states that the device "met the pre-defined acceptance criteria."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing was conducted on the subject device to validate the Advanced Force Transmission, Adaptive Bending features" and lists other performance tests. These are bench tests and thus do not involve human subjects or clinical data in the traditional sense. The sample size for these engineering/performance tests (e.g., number of endoscopes tested) is not specified. Data provenance related to country of origin or retrospective/prospective is not applicable as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a technical device performance study, not a perception or diagnostic accuracy study requiring expert human readers to establish ground truth. Therefore, this information is not applicable. The ground truth is based on engineering specifications and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as this is not a study involving human 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
Not applicable. This is a 510(k) for an endoscope itself, comparing its performance characteristics to a predicate endoscope. It does not involve AI or human reader performance comparisons.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is an endoscope, not an AI algorithm. Its performance is measured directly through physical and optical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for these performance tests (e.g., field of view, bending capability, resolution) are established based on engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, the "acceptance criteria" would be a defined range or value for a characteristic that the device must meet to be considered functional and equivalent to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.