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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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For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

The InstaFlo Bowel Catheter System Kit contains two main parts: the catheter 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.

This document does not describe a study to prove a device meets acceptance criteria. Instead, it is a 510(k) summary for the InstaFlo Bowel Catheter System Kit, which is a medical device.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). This is typically achieved by demonstrating substantial equivalence to a predicate device, rather than through a clinical study with acceptance criteria in the traditional sense.

Here's how to interpret the document in the context of your request:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for a modification to an existing device (ActiFlo Indwelling Bowel Catheter System Kit), the "acceptance criteria" are implied by demonstrating substantial equivalence. The document highlights changes in technological characteristics and intended use compared to the predicate, and asserts that product evaluation supports acceptability.

The "study" that proves the device meets the acceptance criteria (i.e., substantial equivalence):

The document explicitly states: "Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the device for its intended clinical use."

This indicates that the primary "study" or evaluation performed was biocompatibility testing. The "product evaluation" mentioned likely encompasses a review of the design changes, materials, manufacturing processes, and how they compare to the predicate device to ensure the modified device is as safe and effective.

Detailed answers to your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance
See the table above. The "acceptance criteria" are not given as numerical thresholds of performance metrics but rather as demonstration of substantial equivalence through design and material property comparisons, and biocompatibility testing.

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

• The document does not specify sample sizes for biocompatibility testing. Biocompatibility testing often involves in vitro and in vivo tests, which have their own sample size considerations, but these are not detailed here.
• Data provenance: Not specified, but standard ISO 10993 testing is generally conducted by accredited labs. It is not indicated if the data is retrospective or prospective, but typical biocompatibility testing would be considered prospective for the specific material/device being tested.

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 applicable in this context. Biocompatibility testing results are generally evaluated against established biological endpoints and acceptance criteria from ISO 10993 standards, rather than requiring expert consensus for a "ground truth" like in clinical image interpretation studies.

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

• Not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation), not for objective physical or chemical tests like biocompatibility.

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

• No. This is a medical device (catheter system), not an AI/imaging device. Therefore, MRMC studies are not relevant.

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

• No. This is a physical medical device, not an algorithm.

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

• For biocompatibility testing, the "ground truth" is defined by the established biological endpoints and thresholds of the ISO 10993 standards and FDA guidance (G95-1). This involves assessing for cytotoxicity, sensitization, irritation, acute systemic toxicity, etc., as per the standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not applicable. There is no training set.

In summary, the information provided is typical of a 510(k) submission for a device modification, focusing on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance (in this case, primarily biocompatibility testing), rather than a clinical study with detailed acceptance criteria and performance metrics.

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