(27 days)
The SIS Fistula Plug is for implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal, and enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.
The SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) and is provided in a rolled configuration. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
The provided text describes a 510(k) summary for the SIS Fistula Plug (K050337), which is a medical device. However, it does not include detailed information about acceptance criteria, a specific study proving those criteria were met, or most of the other requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).
The document focuses on demonstrating substantial equivalence to predicate devices through bench and biocompatibility testing, viral inactivation testing, and mechanical testing. It states that "Outcomes show the device to be biocompatible, to be virally inactivated, and meet material, and mechanical, and mechanical characteristics to be sufficient." This is a general statement rather than specific quantitative acceptance criteria or a detailed study report.
Therefore, much of the requested information cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the provided text, indicating where information is missing:
1. Table of acceptance criteria and reported device performance
Given the limited information, specific quantitative acceptance criteria are not provided. The document generally states that the device "meets material, and mechanical, and mechanical characteristics to be sufficient" and is "biopatible" and "virally inactivated."
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Biocompatibility | Outcomes show the device to be biocompatible. |
| Viral Inactivation | Outcomes show the device to be virally inactivated. |
| Material Characteristics | Outcomes show the device to meet material characteristics to be sufficient. |
| Mechanical Characteristics | Outcomes show the device to meet mechanical characteristics to be sufficient. |
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified, but the context implies laboratory testing (bench, biocompatibility, viral inactivation, mechanical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for this type of device (biocompatibility, mechanical properties) is established through standardized laboratory tests, not typically by expert consensus on clinical cases.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This type of testing involves quantitative measurements and observations against established standards, not expert adjudication of subjective findings.
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: No. This document is for a physical medical device (a plug for fistulas), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: Established laboratory standards and validated test methods for biocompatibility, viral inactivation, and mechanical properties of materials. This is implicit in the "Discussion of Tests and Test Results" and "Conclusions Drawn from the Tests."
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This is not an AI/ML device that requires a training set. The "training" for such a device is its manufacturing process and quality control.
9. How the ground truth for the training set was established
- How Ground Truth Established (Training Set): Not applicable.
§ 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.