(21 days)
The CF-Q160 AL/I and the PCF-160 AL/I are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
The EVIS EXERA Colonovideoscopes CF-Q160 AL/1 and PCF-160 AL/1 have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as biopsy forceps and ancillary equipment. The modifications to these devices is to provide a control mechanism to the endoscopes which allows the user the ability to vary the stiffness of the insertion tube, as a means of aiding the physician in inserting the colonoscope into the human colon.
The provided text is a 510(k) submission for the Olympus EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "When compared to similar devices, the EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I do not incorporate any significant changes in intended use, material or design that could affect safety or efficacy." This indicates that a formal clinical study with performance metrics against pre-defined acceptance criteria was not deemed necessary for this 510(k) submission, as the device's modifications primarily involve a control mechanism for insertion tube stiffness, not core imaging or diagnostic capabilities. The submission focuses on comparing the new device's design and intended use to existing predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical test set data is described.
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)
- Cannot be provided. No clinical test set and thus no ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical test set is described.
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
- Cannot be provided. This document predates widespread AI integration in medical devices and does not describe any MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This document describes a physical endoscope, not an algorithm, and does not mention standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical test set requiring ground truth is described.
8. The sample size for the training set
- Cannot be provided. As there's no mention of an algorithm or AI, there is no training set.
9. How the ground truth for the training set was established
- Cannot be provided. As there's no mention of an algorithm or AI, there is no training set ground truth to establish.
Summary of the study/submission:
The submission for the Olympus EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I is a 510(k) premarket notification based on substantial equivalence. It asserts that the modified devices (with a control mechanism to vary insertion tube stiffness) do not significantly alter the safety or efficacy compared to legally marketed predicate devices. The review by the FDA confirmed this substantial equivalence, allowing the devices to be marketed without requiring new clinical trials that would establish specific acceptance criteria and performance against a ground truth dataset. The focus of the submission is a comparison of design and intended use, not clinical efficacy metrics.
§ 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.