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Collagen Tendon Sheet-D is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Device Description

Collagen Tendon Sheet-D is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-D is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet-D is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-D is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.

AI/ML Overview

This 510(k) summary (K122048) describes the Collagen Tendon Sheet-D, a resorbable type I collagen matrix. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Collagen Tendon Sheet, K112423) through a comparison of technical characteristics and non-clinical studies. There is no information provided about a clinical study involving human participants, AI, or specific performance metrics like sensitivity, specificity, or accuracy for a device that relies on such evaluation.

Therefore, the following information is not available in the provided document:

A table of acceptance criteria and reported device performance related to clinical outcomes.
Sample size used for a test set (as no clinical test set for performance evaluation is described).
Data provenance for a clinical test set.
Number of experts used to establish ground truth.
Qualifications of experts.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Effect size of human readers with AI vs. without AI.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How the ground truth for the training set was established.

Based on the provided document, the device met the acceptance criteria by demonstrating substantial equivalence to a legally marketed predicate device through non-clinical studies.

Here's the relevant information that is available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Safety/Biocompatibility:
Cytotoxicity (agarose overlay, liquid and extract methods)	Passed
Pyrogenicity	Passed
Systemic toxicity	Passed
Hemolysis	Passed
Genotoxicity (bacterial and mammalian mutation, chromosomal aberration)	Passed
Intracutaneous reactivity	Passed
Muscle implantation tissue response tests	Passed
Compliance with FDA Blue Book Memorandum G95-1 and ISO 10993-1	Device passed all applicable testing.
Material Characterization:
Chemical composition and purity (SDS-PAGE analysis, collagen typing, residual testing, viral inactivation)	Characterized; same as predicate device.
Mechanical Characterization:
Density	Characterized; intended to demonstrate substantial equivalence with predicate.
Strength	Characterized; intended to demonstrate substantial equivalence with predicate.
Stiffness	Characterized; intended to demonstrate substantial equivalence with predicate.
Tear resistance	Characterized; intended to demonstrate substantial equivalence with predicate.
Compliance with FDA's Guidance for the Preparation of a Premarket Notification for a Surgical Mesh	Testing conducted in accordance with this guidance.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The submission focuses on non-clinical studies (in vitro and in vivo animal studies for biocompatibility, chemical, and mechanical characterization). There is no mention of a clinical test set involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. Ground truth determination by experts is not described as part of this non-clinical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. No clinical test set or adjudication process is mentioned.

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:

No such study was done or reported. This device is a medical implant (collagen matrix), not an AI diagnostic or assistive device, so MRMC studies involving AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No such study was done or reported. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

For biocompatibility: Standardized assay results (e.g., cell viability, toxicity assessments, tissue response).
For material and mechanical characterization: Laboratory measurements and analytical techniques.
Not applicable in the context of expert-derived clinical ground truth.

8. The sample size for the training set:

Not applicable / Not provided. No training set, as this is not an AI/algorithmic device.

9. How the ground truth for the training set was established:

Not applicable / Not provided. No training set for ground truth establishment.

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