(86 days)
Collagen Tendon Wrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Collagen Tendon Wrap is a resorbable type I collagen matrix that provides a nonconstricting encasement for injured tendons. Collagen Tendon Wrap is designed to be an interface between the tendon and tendon sheath or the surrounding tissue. When hydrated, Collagen Tendon Wrap is a conformable, porous collagen sheet designed for easy placement under, around or over the injured tendon. Collagen Tendon Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
The Collagen Tendon Wrap is a medical device, and the provided text describes its safety and effectiveness through various studies. However, the document does not contain information about an AI device or its acceptance criteria. Therefore, most of the requested fields are not applicable.
Here's the information extracted from the provided text, focusing on the device's evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that the device "passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." However, it does not provide specific quantitative acceptance criteria or detailed performance metrics for each test. Instead, it states a general "pass" for safety and qualitative effectiveness.
| Acceptance Criteria (Not explicitly quantitative) | Reported Device Performance |
|---|---|
| Safety/Biocompatibility (FDA Blue Book G95-1, ISO 10993-1) | Passed all selected testing |
| Effectiveness (Design requirements for tendon protector) | Met design requirements |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified, but "Animal studies were conducted." The number of animals or specific experimental groups is not provided.
- Data Provenance: Conducted as "Animal studies." No country of origin is mentioned. The studies are prospective in nature, as they were conducted to demonstrate the effectiveness of this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" for the effectiveness of the Collagen Tendon Wrap was established through animal studies and in vitro characterization, not human expert consensus on diagnostic images.
4. Adjudication Method for the Test Set:
- Not applicable. This concept typically applies to human interpretation of data where discrepancies need to be resolved. For animal study outcomes, the assessment would be based on scientific methods and observations, not adjudication among human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a MRMC comparative effectiveness study was not done. The device is a physical medical implant, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. The Collagen Tendon Wrap is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for the effectiveness of the Collagen Tendon Wrap was based on observations from animal studies (e.g., healing, protection of tendons) and in vitro product characterization studies (e.g., material properties, physical integrity).
8. The Sample Size for the Training Set:
- Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set for this physical medical device.
§ 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.