(102 days)
TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
The TAPESTRY® Biointegrative Implant (TAPESTRY) is composed of collagen and poly(D,Llactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY is designed for stand-alone use. At the discretion of the surgeon. TAPESTRY may be hydrated with sterile isotonic solution.
Preclinical studies of TAPESTRY showed dense collagenous fibrous connective tissue ingrowth into and around the scaffolding.
This document describes a 510(k) premarket notification for the Tapestry Biointegrative Implant. The notification, K212306, seeks to demonstrate substantial equivalence to its predicate device, Tapestry (K201572).
Crucially, the provided text states that the Tapestry Biointegrative Implant (the subject device) is "the same device as its TAPESTRY predicate" with "the same indications for use, design, materials, and technological characteristics." The primary change leading to this 510(k) submission is the addition of validation methods for establishing collagen stability throughout the device's shelf life, and the introduction of two new product sizes within the already cleared size range.
Given this context, the acceptance criteria and the study proving the device meets these criteria are not based on new clinical performance data for the device itself. Instead, the submission relies on the established performance of the predicate device and additional bench testing for the new shelf-life validation.
Therefore, many of the requested details regarding clinical studies (such as sample size for test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for clinical data) are not applicable to this 510(k) submission for the Tapestry Biointegrative Implant, as no new clinical performance claims or studies are presented.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance for Tapestry Biointegrative Implant (K212306)
The acceptance criteria for this 510(k) submission are primarily focused on demonstrating that the subject device, despite minor changes (shelf-life validation and new sizes), maintains substantial equivalence to its predicate device. This means ensuring that the changes do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Design and Materials remain the same as Predicate. | The TAPESTRY® Biointegrative Implant (subject device) is stated to be "the same device as its TAPESTRY predicate, with the same indications for use, design, materials, and technological characteristics". It is composed of collagen and poly(D,L-lactide). |
| Intended Use/Indications for Use remain the same as Predicate. | "TAPESTRY is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue." (Identical to predicate). |
| Safety and Biocompatibility are unaffected. | "Past performance testing (safety, biocompatibility, bench) of the predicate device is directly applicable to the subject device." No new safety or biocompatibility concerns were identified with the changes. |
| Bench Performance is maintained. | "Past performance testing (...) of the predicate device is directly applicable to the subject device." |
| Shelf-life validation for collagen stability is adequate. | "Additional tests to confirm the collagen stability of the device were performed. Hydroxyproline analysis was conducted to confirm the collagen quantity and Fourier Transform Infrared (FTIR) analysis was conducted to confirm collagen quality." This testing, combined with predicate stability testing, supports the expanded shelf life. |
| New product sizes do not impact performance. | "No new performance testing was required to support the additional product sizes, as the sizes are within the cleared size range and the cleared labeling allows for trimming of the device." |
| Overall substantial equivalence to Predicate. | The submission concludes: "The TAPESTRY subject device is substantially equivalent to the TAPESTRY predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable for a clinical test set as no new clinical performance studies were conducted for this 510(k) submission.
- Data Provenance: The reliance is on existing data from the predicate device (K201572) and new bench test data for collagen stability. The document does not specify the country of origin for the predicate's data. The collagen stability testing would have been done in a laboratory, but specific details on its provenance (e.g., specific country, specific lab) are not provided. The study design is retrospective in the sense that it relies on performance data of the previously cleared predicate device, supplemented by prospective bench testing for the new shelf-life validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical test set requiring expert ground truth establishment for this 510(k). The evaluation of substantial equivalence is based on engineering, material, and bench test data, as well as the prior clearance of the predicate.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical 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 implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) is the established safety and performance of the legally marketed predicate device (K201572) for its intended use, combined with analytical and material testing data (Hydroxyproline analysis, FTIR analysis) to confirm the new aspects (collagen stability) do not alter the inherent properties or introduce new risks. Preclinical animal studies of the predicate showed "dense collagenous fibrous connective tissue ingrowth into and around the scaffolding," which would likely have been part of the initial "ground truth" for the predicate's safety and effectiveness.
8. The sample size for the training set:
- Not applicable. No training set for an AI/algorithm was used. The device is a physical implant.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/algorithm was used.
§ 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.