(147 days)
The WMT Collagen Dermal 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, and other tendons. The WMT Collagen Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. 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 WMT Collagen Dermal Matrix is a sterile, non-perforated processed porcine collagen dermal matrix.
The provided document describes a 510(k) premarket notification for the "WMT Collagen Dermal Matrix," a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through clinical trials or standalone performance studies like those for AI/ML-based medical devices.
Therefore, the requested information, which is relevant to AI/ML device evaluations, is largely not applicable or not explicitly detailed in this document for the WMT Collagen Dermal Matrix. The document primarily focuses on a comparison to predicate devices through bench testing of mechanical properties.
Here's an assessment based on the available information:
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A table of acceptance criteria and the reported device performance
- Not applicable in the context of this 510(k) submission as requested for AI/ML devices. The document states that "Mechanical testing characterized the suitability of the subject device, WMT Collagen Dermal Matrix, in orthopedic applications, and compared the test results of both OrthADAPT™ FX and RESTORE® predicate devices." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, F1-score thresholds) and detailed performance metrics against those criteria are not provided. The bench testing would have compared mechanical properties but these are not quantified in the summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This device is a surgical mesh, and its evaluation primarily involved bench testing (mechanical characterization) rather than a test set of patient data. The document does not describe patient data or clinical trials with test sets.
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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. No test set requiring expert ground truth establishment is described for this device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described for this device.
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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. This device is a surgical mesh, not an AI/ML diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical mesh, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not explicitly defined in typical AI/ML terms. For a surgical mesh, the "ground truth" for mechanical testing would be established by standardized testing methods and material properties, rather than expert consensus on a diagnostic outcome or pathology. The document indicates "bench testing comparing predicate devices and the subject device," implying that the performance of the device was compared directly against the mechanical properties of the predicate devices.
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The sample size for the training set
- Not applicable. This device is a surgical mesh and does not involve a training set as an AI/ML algorithm would.
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How the ground truth for the training set was established
- Not applicable. No training set is involved for this device.
Summary for the WMT Collagen Dermal Matrix (K073219):
The 510(k) submission for the WMT Collagen Dermal Matrix demonstrates substantial equivalence to predicate devices primarily through bench testing of mechanical properties. The report states: "Mechanical testing characterized the suitability of the subject device, WMT Collagen Dermal Matrix, in orthopedic applications, and compared the test results of both OrthADAPT™ FX and RESTORE® predicate devices, surgical meshes which are currently indicated for orthopedic applications."
The acceptance criteria are implicitly that the mechanical properties of the WMT Collagen Dermal Matrix are comparable to or within acceptable ranges of the predicate devices. However, specific numerical acceptance thresholds and the detailed results of the mechanical testing that "proves the device meets the acceptance criteria" are not provided in this summary document. The "study" mentioned is "new bench testing comparing predicate devices and the subject device." This testing would have involved engineering and material science standards rather than clinical or AI/ML evaluation metrics.
§ 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.