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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 is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. The implant is provided sterile for single use only. It is supplied as a standalone implant, in an insertion sleeve, or on an introducer assists in delivering the implant to the surgical site during arthroscopic procedures. The device is provided in a dual pouch configuration.

This document is an FDA 510(k) summary for the TAPESTRY® Biointegrative Implant. It outlines the device, its intended use, and compares it to a predicate device. However, it does not describe acceptance criteria, nor does it present a study that proves the device meets specific performance criteria related to AI/algorithm performance.

The performance data section explicitly states: "The testing in this submission was directly applicable to the new introducer and no additional performance testing was required for the implant based on the modification." This indicates that the reported performance data focuses on the mechanical aspects of the introducer instrument, rather than clinical efficacy or AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/algorithm, as the provided document does not contain such details. It pertains to a physical medical device (an implant and its introducer) and its regulatory clearance based on substantial equivalence to a predicate device.

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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

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.

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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 device is composed of collagen and poly(D,L-lactide). 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.

The provided text describes a 510(k) premarket notification for the TAPESTRY® Biointegrative Implant, a Class II surgical mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for an AI-powered diagnostic device with specific acceptance criteria and performance metrics typically associated with AI.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/diagnostic device.

The text discusses:

• The device (TAPESTRY® Biointegrative Implant) and its intended use (management and protection of tendon injuries).
• Comparison of technological characteristics with a predicate device (Rotation Medical Inc. Collagen Tendon Sheet).
• Preclinical studies (in vivo animal study) to evaluate tissue response, systemic toxicity, and device resorption, not performance metrics of an AI diagnostic tool.
• Biocompatibility testing against ISO 10993-1 standards.

It is a submission for a surgical implant, not an AI-powered diagnostic tool. Hence, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" as they apply to diagnostic accuracy (e.g., sensitivity, specificity, AUC) for an AI model are not present in this document. There's no mention of:

• A table of acceptance criteria with reported device performance for an AI/diagnostic task.
• Sample sizes for test sets in an AI context.
• Number of experts or their qualifications for ground truth.
• Adjudication methods for test sets.
• MRMC studies or effect sizes for human reader improvement.
• Standalone AI performance.
• Type of ground truth (e.g., pathology, outcomes data in an AI context).
• Sample size for a training set or how its ground truth was established.

In summary, this document is entirely unrelated to the type of AI/diagnostic device evaluation you are asking about.

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