(27 days)
The modified SIS Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal fistulas. The device is supplied sterile and is intended for one-time use.
The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a button to provide increased retention of the plug and improved blockage of the fistula. The device is packaged in a lyophilized (freeze-dried) state, and supplied sterile in a sealed double pouch system.
The provided text details a 510(k) submission for a modified medical device, the SIS Fistula Plug. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance (e.g., efficacy, accuracy, or clinical outcomes). The submission focuses on demonstrating substantial equivalence to a predicate device, specifically addressing modifications made to the original SIS Fistula Plug.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth cannot be extracted from this document as such studies were not part of this 510(k) submission.
Here's an analysis of what can be extracted and an explanation of what cannot:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria for this submission: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (the original SIS Fistula Plug [510(k) No. K050337]). This is achieved by showing that the modified device has similar intended use, materials, and technological characteristics, and that any modifications do not raise new questions of safety and effectiveness.
- Reported Device Performance: The document states that the modified device underwent:
- Biocompatibility testing
- Viral inactivation testing
- Mechanical testing
- An analysis of risk factors.
- Outcomes: "Outcomes show the device to be biocompatible, adequately disinfected, and with appropriate mechanical characteristics." Also, "Outcomes from the evaluation of the modified SIS Fistula Plug provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to the predicate device in terms of intended use and technological characteristics."
| Aspect of Equivalence | Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device | Similar to predicate device |
| Materials | Same as or comparable to predicate device with no new safety/efficacy concerns | Manufactured from porcine small intestinal submucosa (SIS) - same base material as predicate. Subjected to biocompatibility and viral inactivation testing. |
| Technological | Similar to predicate device, modifications do not raise new safety/efficacy concerns | Tapered configuration with a button for increased retention and improved blockage. Bench testing and biocompatibility testing performed. Mechanical characteristics found appropriate. |
| Safety | Biocompatible and adequately disinfected | Biocompatible and adequately disinfected. |
| Effectiveness | Appropriate mechanical characteristics and suitable for soft tissue reconstruction | Appropriate mechanical characteristics. Suitability for use in soft tissue reconstruction. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided because this submission relies on demonstrating substantial equivalence through bench testing, biocompatibility testing, and risk analysis, rather than a clinical efficacy study with a test set of patients or data. The testing mentioned (biocompatibility, viral inactivation, mechanical) would typically involve laboratory samples, not human patient data sets.
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. There was no "test set" in the context of human data or diagnoses requiring expert ground truth in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
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 a surgical mesh for fistula repair, not an AI-powered diagnostic tool, so MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the assessments performed (biocompatibility, mechanical testing, viral inactivation), the "ground truth" would be established by standard scientific and engineering methodologies, accepted laboratory protocols, and regulatory guidelines for these types of tests, rather than expert consensus on clinical cases or pathology.
8. The sample size for the training set
- Not applicable. There is no mention of "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of "training set" as this is not an AI/ML device.
In summary: This 510(k) submission is for modifications to an existing physical medical device (SIS Fistula Plug). The "study" referenced is a series of tests (biocompatibility, viral inactivation, mechanical, and risk analysis) intended to demonstrate that the modified device remains substantially equivalent to its predicate. It does not involve clinical studies with human participants, AI algorithms, or the kinds of intricate data analysis and expert review typically found in submissions for diagnostic AI devices.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.