(90 days)
The Colonic Splinting Overtube is indicated for use with an endoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the endoscope during the colonoscopy procedure. The Colonic Splinting Overtube is intended to provide for easy advancement of the scope while minimizing mucosal pinching.
The US Endoscopy Colonic Splinting Overtube is an overtube that includes a soft distal . tip, an irrigation line, proximal seal at the handle, a hydrophilic coating, and an optional adhesive anchor.
The provided text describes a 510(k) premarket notification for a medical device, the US Endoscopy Colonic Splinting Overtube. It does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method), or MRMC comparative effectiveness studies.
The document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on design characteristics, indications for use, and a statement that "performance testing consisted of functional bench testing." It does not provide specific data, metrics, or detailed study results that would allow for the completion of the requested table and study description.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be inferred or stated based on the document:
1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or quantitative performance metrics are provided in the document. The document states: "Performance testing consisted of functional bench testing." and "All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible." It concludes that the device is "safe and effective for its intended use" based on these general statements and comparison to 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)
Not mentioned in the document.
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 mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the document.
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 device is an overtube, an accessory for endoscopy, not an AI diagnostic tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (overtube), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not mentioned in the document. The "performance testing" was described as "functional bench testing," implying laboratory or engineering tests, not clinical evaluations against a medical ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
§ 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.