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The InHealth Soft Sleeve Colonoscope Splint is indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. The InHealth Soft Sleeve Colonoscope Splint is intended to provide for easy advancement of the scope while avoiding damage to the colon.

The InHealth Soft Sleeve Colonoscope Splint is a disposable splint or overtube for use in colonoscopy to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. This device is a silicone tube with a soft distal tip and a proximal grip. The distal tip provides a soft, conforming and flexible tapered shape that hugs the scope and facilitates insertion. The entire splint, with the exception of the outer surface of the proximal grip, is coated with a lubricious, hydrophilic coating. This lubricious coating, when wetted, enables a smooth passage of the device along the colonoscope and of the splint through the sigmoid colon. The proximal grip is fitted with an injection port for injecting water into the inside of the splint tube to facilitate lubrication. The tip is grooved to allow flow of water from the inside diameter of the splint to the outside diameter to provide a controlled lubrication of the splint, the colonoscope, and the surrounding mucosa. The proximal grip, which is larger than the shaft, ensures that the entire tube does not pass through the anus and enter the rectum. The Soft Sleeve Splint is a non-sterile disposable device, intended for one-time use only, not intended for reuse.

The provided text describes a 510(k) premarket notification for a medical device called the "InHealth Soft Sleeve Colonoscope Splint." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through extensive clinical studies as might be required for a PMA. Therefore, the document does not contain information about acceptance criteria, detailed study designs, sample sizes for test/training sets, or expert ground truthing as typically requested for AI/ML device evaluations.

The closest analogue to "acceptance criteria" and "reported device performance" in this context is the concept of "substantial equivalence" to predicate devices, focusing on technological characteristics and intended use.

Here's the information parsed from the document based on your request, with an emphasis on what is not available within this type of regulatory submission:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided: This 510(k) submission does not describe a performance study with a test set that would have a sample size or data provenance as typically understood for AI/ML device evaluations. The submission relies on demonstrating substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided: No studies involving "ground truth" establishment by experts are described in this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable / Not Provided: No test set or adjudication method 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

• Not Applicable / Not Provided: This device is a physical medical instrument (a colonoscope splint), not an AI/ML software device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided: As this is a physical medical device, not an algorithm, this question is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Provided: No ground truth data is described as being used for this 510(k) submission.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: As this device is not an AI/ML algorithm, this question is not relevant.

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