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Bovine Dermis Collagen Dermal Matrix is indicated for the management of wounds, including:

• . Full thickness and Partial thickness wounds
• . Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
• . Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• . Trauma wounds (abrasions, lacerations, and skin tears)
• Draining wounds
• Partial thickness burns

Bovine Dermis Collagen Dermal Matrix is an absorbent, porous, collagen matrix engineered from purified collagen derived from bovine dermal tissue. Bovine Dermal Matrix should be applied directly to the wound, covering the entire wound surface.
Bovine Dermis Collagen Dermal Matrix is supplied sterile, non-pyrogenic and for single use only.

The Collagen Matrix, Inc. Bovine Dermis Collagen Dermal Matrix (K243071) is a medical device. The provided text outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence for regulatory purposes.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a go/no-go fashion with numerical targets for clinical performance. Instead, it compares the subject device to predicate devices across various technical characteristics. The implicit acceptance criterion is that the subject device's performance is either equivalent to or better than the predicate devices, or that any differences do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify a "test set" in the context of clinical or performance data with a specific number of cases or patients. The studies described are in vitro characterization tests, biocompatibility tests, and a viral inactivation study. These are conducted on samples of the device itself or in laboratory settings, not on patient data.
• Data Provenance: Not applicable in the context of clinical patient data. The studies are laboratory-based and conducted on the manufactured device.

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. The studies are not clinical studies requiring expert ground truth for interpretation of patient data. They are lab tests for material properties, biological safety, and viral inactivation.

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

Not applicable. This pertains to clinical studies involving human readers and adjudicated outcomes, which are not described here.

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. The document describes laboratory-based testing of a dermal matrix, not a diagnostic AI device requiring human reader analysis.

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

Not applicable. This pertains to AI algorithm performance studies, which are not described here.

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

Not applicable in the human clinical sense. For the in vitro tests (Absorbency, pH, Thermal Transition Temperature, Density, Crosslinking Agent Residual Content, Pyrogenicity), the "ground truth" would be established by validated analytical methods and reference standards. For biocompatibility, it would be based on established international standards (e.g., ISO 10993 series) and their respective endpoints. For viral inactivation, it would be based on virological assays.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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