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Procon 2 is a single use catheter with an inflatable balloon cuff intended to act as a barrier to the passage of fecal matter through the rectum.

Procon2 is for an individual with fecal incontinence that has impaired quality of life, is sufficiently motivated psychologically to participate in their own treatment, and having good manual dexterity is an ideal candidate. He or she is either not a surgical candidate or has not responded to conservative treatment.

A single use rectal silicone catheter with a water filled cuff acting as a barrier to the unintended passage of feces through the rectum.

The provided text describes the Procon2 device, a rectal catheter for fecal incontinence, and its equivalence to a predicate device (Procon). However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a detailed study proving performance. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical trial with acceptance criteria.

Here's what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: The text refers to "Patient acceptance trials of the Predicate Device" that "determined the efficacy of the Predicate Device as a 'mechanical barrier' to the impending passage of feces." It further quotes a medical text stating, "The mechanical barrier component, however, cannot be underestimated even when patients voluntarily turned off the alarm, with the catheter still in position, very few experienced episodes of focal accidents or major leakage." This refers to the predicate device, Procon, not Procon2 directly. The document claims Procon2 is substantially equivalent due to similar technological characteristics and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified for either the predicate device's trials or any new trials for Procon2.
• Data Provenance: The trials for the predicate device were "conducted at the Cleveland Clinic Florida." This indicates the data is from the United States and was likely prospective as they were "patient acceptance trials," but the timeline isn't specified in detail for Procon2.

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)

• Number of Experts & Qualifications: Not specified. The trials for the predicate device were under the "direction of the Chairman, Dept. of Colorectal Surgery, S.D. Wexner M.D., F.A.C.S., F.R.C.S., F.R.C.S.Ed., F.A.S.C.R.S., F.A.C.G." This indicates a highly qualified expert in colorectal surgery, but it doesn't state how many experts were involved in establishing "ground truth" or assessing patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not applicable. This device is a physical medical device (rectal catheter), not an AI diagnostic tool that involves human readers interpreting data.

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

• Standalone Performance: Not applicable. This is a physical device, and its performance is assessed by its function as a mechanical barrier. The predicate device had an alarm, but Procon2 does not.

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

• Type of Ground Truth: For the predicate device, the "efficacy... as a 'mechanical barrier' to the impending passage of feces" was "determined" through "patient acceptance trials." This strongly suggests patient-reported outcomes data and direct observation/assessment of fecal leakage events as the ground truth.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The manufacturer is relying on the predicate device's clinical performance and a demonstration of substantial equivalence through comparable technological characteristics.

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

• Ground Truth for Training Set: Not applicable.

Summary of Device and Evidence Presented:

• Device: Procon2, a single-use rectal silicone catheter with a water-filled cuff, intended as a barrier to fecal matter for patients with significant fecal incontinence who are not surgical candidates or have not responded to other treatments.
• Study Proving Performance: The document refers to "Patient acceptance trials of the Predicate Device" (Procon) conducted at the Cleveland Clinic Florida under the direction of Dr. S.D. Wexner. These trials determined the predicate device's efficacy as a "mechanical barrier" and are cited in a medical text.
• Key Finding (from Predicate Device): "very few experienced episodes of focal accidents or major leakage" when the catheter (predicate device) was in position.
• Procon2's Claim: Substantial equivalence to the predicate device based on similar intended use and technological characteristics, despite changes like silicone material (vs. latex), water cuff (vs. air), and absence of an electronic alarm. The submission argues that the mechanical barrier function, demonstrated for the predicate, is the key component.

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