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The TRELLIS Collagen Ribbon is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, and other tendons. The TRELLIS Collagen Ribbon is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

The subject TRELLIS™ Collagen Ribbon is a narrow, ribbon-like collagen matrix which is identical in material and processing to the predicate WMT Collagen Ribbon (rebranded TRELLISTM Collagen Ribbon - K120019) and includes the sizes of the predicate with an additional thickness offering. The ribbon-like dimensions of the subject device allow for the same surgical techniques as the predicate and the subject has the same intended use-reinforcement of soft tissue in orthopedic applications. The subject TRELLIS™ Collagen Ribbon is the identical source material to the predicate and is manufactured and sterilized in the same manner.

The provided text is a 510(k) summary for the TRELLIS™ Collagen Ribbon. It describes acceptance criteria in terms of performance characteristics. However, it does not describe an AI device, and therefore does not have information related to expert ground truth establishment, sample sizes for training/test sets for AI, or MRMC comparative effectiveness studies.

Here's the information extracted and formatted as requested, with "N/A" for sections not applicable to this non-AI medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria: The document directly states that "Histology results indicated no difference in revascularization and cellular infiltration for the subject versus the predicate." and "Rehydration, tensile, and suture retention testing... shows acceptable performance characteristics and substantial equivalence to the predicate." This implies that the acceptance criteria for the new device were primarily non-inferiority or substantial equivalence to the predicate device in these specific performance measures.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not explicitly stated, as this was an animal study and mechanical testing. The document refers to "an animal study" and "tensile, and suture retention testing" without specifying the number of samples or animals.
• Data Provenance: The animal study suggests prospective data collection in an animal model. The country of origin for the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• N/A (This is not an AI device, so ground truth in the context of expert consensus on data interpretation is not applicable here.)

4. Adjudication Method for the Test Set

• N/A (Not an AI device; not applicable for this type of testing.)

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

• N/A (Not an AI device; no human-in-the-loop performance or AI assistance involved.)

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• N/A (Not an AI device; no algorithm performance to evaluate.)

7. The Type of Ground Truth Used

• Animal Histology: For cellular infiltration and revascularization.
• Mechanical Testing Results: For rehydration, tensile strength, and suture retention.

8. The Sample Size for the Training Set

• N/A (Not an AI device; no training set in this context.)

9. How the Ground Truth for the Training Set Was Established

• N/A (Not an AI device; no training set in this context.)

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The Collagen Ribbon Tissue Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, and other tendons. The Collagen Ribbon Tissue Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

The subject Collagen Ribbon Tissue Matrix is a narrow, ribbon-like version of the predicate WMT Collagen Dermal Matrix (rebranded BIOTAPE XM® Tissue Matrix - K073219). The ribbon-like dimensions of the subject device allow for new surgical techniques compared to the predicate without changing the intended use-reinforcement of soft tissue in orthopedic applications. The subject Collagen Ribbon is the identical source material to the predicate and is manufactured and sterifized in the same manner.

The provided text describes a medical device called the "Collagen Ribbon Tissue Matrix" and its substantial equivalence to a predicate device (WMT Collagen Dermal Matrix, K073219). The submission focuses on non-clinical evidence to demonstrate this equivalence. Therefore, the questions related to clinical studies, human reader performance, training and test set ground truth, and expert adjudication are not applicable as no such studies were performed or described for this 510(k) submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria for a novel device. The "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to maintain similar characteristics.

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

• Sample Size: Not explicitly stated for specific tests. The document refers to "biocompatibility testing," "animal results," "histology results," "bench testing," "mechanical testing," and "rehydration testing." However, the number of samples or animals used for each test is not detailed.
• Data Provenance: The data primarily comes from non-clinical testing conducted by the manufacturer, Wright Medical Technology, Inc., for both the subject device and the predicate device (K073219). The tests were done in compliance with U.S. Food and Drug Administration regulations.

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)

Not applicable. This submission relies on non-clinical laboratory and bench testing, not on human expert interpretations of medical images or data.

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

Not applicable. This submission relies on non-clinical laboratory and bench testing, not on adjudicated expert opinions.

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. No MRMC study was conducted or described, as this is a material science device, not an AI or imaging device involving human readers.

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 the non-clinical tests would be the established scientific and regulatory standards for material performance and safety. For example:

• Biocompatibility: Compliance with ISO standards and FDA regulations (21 CFR, Part 58) for various toxicity and reactivity assessments.
• Material Characteristics: Histological analysis confirming specific cellular and matrix structures.
• Mechanical Performance: Standard test methods (e.g., ASTM) for tensile strength, suture retention, etc.

8. The sample size for the training set

Not applicable. No training set is mentioned as this device does not involve machine learning or AI.

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

Not applicable. No training set is mentioned.

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