(121 days)
Collagen Tendon Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Collagen Tendon Sheet is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
This K112423 510(k) summary describes the Collagen Tendon Sheet device and its substantial equivalence determination to a predicate device. This submission relies heavily on a comparison to the predicate, rather than an independent de novo study with acceptance criteria. Therefore, the requested information elements related to standalone performance, MRMC studies, sample sizes, and ground truth establishment for a new device's performance study are not directly available from this document.
However, I can extract and infer information relevant to the substantial equivalence determination for this device, presented to the best of what the document provides:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense for a new device's performance study. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The "performance" is therefore measured against how closely the new device matches the predicate's characteristics and safety profile.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated for Collagen Tendon Sheet) | Notes |
|---|---|---|
| Intended Use Equivalence: Same intended use as the predicate device. | "Collagen Tendon Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue." (Matches predicate's use) | Stated explicitly. |
| Technological Characteristics Equivalence: Same design, material characterization, chemical composition, purity, density, and strength as predicate. | "Collagen Tendon Sheet and its predicate device have the same technological characteristics. In particular, Collagen Tendon Sheet and its predicate are the same with respect to intended use, design, material characterization." | |
| "Collagen Tendon Sheet and its predicate have been characterized for chemical composition, purity, density, and strength to demonstrate substantial equivalence." | Demonstrated through in vitro characterization studies. Minor differences in size, thickness, and form (flat sheet) acknowledged but deemed not to affect equivalence. | |
| Manufacturing Equivalence: Similar processing, same facilities, same manufacturer, same raw materials as predicate. | "The Collagen Tendon Sheet and its predicate device are manufactured with similar processing, in the same facilities, by the same manufacturer, using the same raw materials." | Stated explicitly. |
| Biocompatibility: Meet established standards for biological evaluation of medical devices. | "The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." | Demonstrated through in vitro and in vivo biocompatibility studies. |
| Safety (Viral Inactivation): Ensure viral safety of the product. | "Viral inactivation studies were performed to ensure the viral safety of the product." | Demonstrated through viral inactivation studies. |
| Efficacy (Animal Study): Demonstrate efficacy comparable to the predicate device in an animal model. | "An animal efficacy study was conducted to evaluate the device as compared to its predicate device." (No specific results provided, but the conclusion states "animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device.") | Study performed, findings used to support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for specific studies (e.g., in vitro, biocompatibility, animal efficacy). The conclusion states "The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, as well as the animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device." This implies these studies formed the basis for the "test" of substantial equivalence.
- Data Provenance: Not specified, but given the company address (Plymouth, MN) and FDA submission, it is likely mostly US-based data, though not explicitly stated. The studies are described as pre-market (non-clinical).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this 510(k) submission, as it relies on pre-clinical studies (in vitro, animal) and comparison to a predicate, not on a human-read diagnostic test requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic device requiring human adjudication of results.
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, an MRMC comparative effectiveness study was not done. This device is a surgical mesh/tendon sheet, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
"Standalone" in the context of an algorithm or AI is not applicable here. The device itself is a physical implant. The listed studies (in vitro, biocompatibility, animal efficacy) represent the "standalone" performance evaluation of the device's material and biological properties.
7. The Type of Ground Truth Used
- For in vitro characterization: Laboratory measurements and established material science standards.
- For biocompatibility: Standards like FDA G95-1 and ISO 10993-1, with endpoints like cytotoxicity, irritation, sensitization, systemic toxicity, etc. (often evaluated by trained toxicologists/pathologists as per standard protocols).
- For animal efficacy study: Animal model outcomes (e.g., tendon healing, tissue response) compared against the predicate device. These would be assessed by veterinary researchers and often histopathologists.
- For viral inactivation: Established viral testing protocols and assays.
8. The Sample Size for the Training Set
Not applicable. This device does not use an algorithm that requires a training set. The data used for demonstrating its properties and equivalence would be considered "test" data in a general sense, not "training" data for an AI model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an algorithm.
§ 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.