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

Collagen Tendon Sheet-DDI is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-DDI is designed to provide a layer between the tendon and the surrounding tissue during healing. When hydrated, Collagen Tendon Sheet-DDI is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-DDI is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and is packaged preloaded in a cartridge, for use with the Rotation Medical Delivery Instrument, in a dual sterile seal tray-in-tray configuration.

This document describes a 510(k) premarket notification for a medical device called "Collagen Tendon Sheet-DDI." This device is a resorbable type I collagen matrix used for the management and protection of tendon injuries. The key aspect of this submission is that the Collagen Tendon Sheet-DDI is substantially equivalent to a previously cleared predicate device, "Collagen Tendon Sheet-D" (K122048). The only difference between the two is the packaging, which has been modified to facilitate arthroscopic delivery.

Therefore, the "study" proving the device meets acceptance criteria is not a clinical trial in the traditional sense, but rather a series of non-clinical performance tests designed to demonstrate that the change in packaging does not adversely affect the device's safety and effectiveness.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Since this submission is based on substantial equivalence due to packaging changes, the acceptance criteria are linked to ensuring the new packaging and delivery system maintain the integrity and functionality of the core collagen sheet. The document highlights specific tests performed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of collagen sheets tested for suture pull-out). These tests are typically performed in a laboratory setting, and the data provenance would be internal to the manufacturer (Rotation Medical, Inc. in Plymouth, MN, USA), and would be considered prospective in the sense that the tests were carried out specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable for this submission. The "ground truth" for non-clinical performance tests like suture pull-out or biocompatibility is established by adherence to recognized standards (e.g., ISO, ASTM) and established industry protocols, not by expert consensus in a clinical context. The performance is measured against quantifiable physical or chemical properties, or established biological response endpoints.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting subjective outcomes or imaging results where agreement among multiple evaluators is needed to establish a "ground truth." For the non-clinical tests described, the outcomes are objectively measured.

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

This is not applicable. MRMC studies are related to evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiology scans) often in the context of AI assistance. This submission pertains to a surgical mesh and its delivery system, not a diagnostic device.

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

This is not applicable. This device is a physical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance tests is based on:

• Established engineering principles and material science standards: For tests like suture pull-out strength, hydrothermal transition temperature, and mechanical integrity.
• Recognized biocompatibility standards (e.g., ISO 10993): For evaluating the biological safety of the materials.
• Sterility and endotoxin limits: For ensuring the safety of the product related to manufacturing processes.

8. The sample size for the training set

This is not applicable. The Collagen Tendon Sheet-DDI is a physical medical device. There is no "training set" in the context of machine learning or AI, as the device's function is mechanical and biological, not based on learned patterns from data.

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

This is not applicable as there is no training set.

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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.

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.

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:

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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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.

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.

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