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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.

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