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A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

The InstaFio Bowel Catheter System Kit contains two main parts: the catheter (made with odor barrier film) and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed.

The provided text describes a 510(k) summary for the InstaFlo Bowel Catheter System Kit, which details performance testing conclusions but does not contain specific acceptance criteria or an in-depth study report with the detailed information requested.

Therefore, I cannot populate the table and answer all questions with the provided information. However, I can extract what is available.

1. Table of Acceptance Criteria and Reported Device Performance

Details not explicitly available in the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document states "non-clinical testing" was performed, which typically refers to bench testing rather than human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this was non-clinical testing.
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 is a medical device (catheter system), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter system), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for non-clinical testing. Ground truth in this context would be adherence to engineering specifications and performance standards.
8. The sample size for the training set: Not applicable, as this is non-clinical device testing, not an AI model.
9. How the ground truth for the training set was established: Not applicable, as this is non-clinical device testing, not an AI model.

Summary of available information regarding the "study" (non-clinical testing):

• Type of Study: Non-clinical testing for functional and structural parameters, biocompatibility, odor barrier capabilities, and connection/joint integrity (bond strength and leakage).
• Purpose: To demonstrate that the modified InstaFlo Bowel Catheter System Kit is as safe and effective and substantially equivalent to its predicate device (K100273).
• Key Findings:
  • Biocompatibility testing met US FDA Office of Device Evaluation General Program Memorandum #G95-1 and ISO 10993 standards.
  • Odor testing verified the odor barrier capabilities compared to the predicate.
  • Connections and joints tested for bond strength and leakage showed acceptable results, demonstrating no impact from the change in tubing.

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