(227 days)
The Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following:
- For use in keeping the suitable depth of the colonoscope's field of view.
The GCE Focus Cap has the shape of a short transparent tube which is attached to the distal end of the colonoscope. The Focus Cap is designed to facilitate the scope's view during colonoscopy procedures.
The provided text describes a 510(k) premarket notification for the "Focus Cap" device. This document does not describe a study that uses acceptance criteria for algorithm performance in the way typically seen for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance testing related to mechanical and biocompatibility aspects of the physical device.
Therefore, many of the requested categories are not applicable to the information contained in this document.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: All test requirements as specified by test protocols and pre-determined acceptance criteria. | All test requirements were met. |
| Biocompatibility Testing: All test requirements as specified by test protocols and pre-determined acceptance criteria. | All test requirements were met. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "test protocols," but does not detail the sample sizes or provenance for the mechanical and biocompatibility testing.
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)
Not applicable. This document is for a physical medical device (a cap for a colonoscope), not an AI/ML device that requires expert-established ground truth for its performance in a clinical task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document is for a physical medical device and does not involve adjudication of interpretations.
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 for a physical medical device and does not involve AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical and biocompatibility testing, the "ground truth" would be established by standardized testing methods and material specifications, not expert clinical consensus or pathology. The document states "All test requirements were met as specified by test protocols and pre-determined acceptance criteria."
8. The sample size for the training set
Not applicable. This document is for a physical device, not an AI/ML model with a training set.
9. How the ground truth for the training set was established
Not applicable. This document is for a physical device, not an AI/ML model with a training set.
§ 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.