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510(k) Data Aggregation
(51 days)
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.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Collagen Ribbon Tissue Matrix) |
|---|---|
| Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, implantation reactions (2wk & 13wk), subchronic & chronic toxicity, carcinogenicity, hemolysis, genotoxicity. | Passed all described biocompatibility testing. |
| Material Composition: Decellularized, intact collagen matrix. | Histology results indicated an identical decellularized, intact collagen matrix. |
| Mechanical Properties: Suitable for orthopedic applications (tensile and suture retention testing). | Maintains the same minimum performance characteristics as the predicate device (confirmed through tensile and suture retention testing). |
| Rehydration Properties: Maintenance of performance after rehydration. | Rehydration testing confirms the same minimum performance characteristics as the predicate device. |
| Sterilization: Same as predicate. | Manufactured and sterilized in the same manner as the predicate. |
| Packaging: No alteration in performance due to packaging changes. | Functional and in vivo performance testing confirms that the addition of a second Tyvek barrier to packaging does not alter performance of the material. |
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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