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Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Collagen Dental Membrane IV is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane IV is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

The provided text describes a 510(k) summary for the "Collagen Dental Membrane IV" device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria based on performance studies. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size for test set: Not specified. The document mentions "in vitro and in vivo tests," but does not detail the specific sample sizes used within these tests.
• Data provenance: "in vitro and in vivo tests." No specific country of origin or whether the data was retrospective or prospective is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. The document does not describe the use of experts to establish ground truth for performance metrics in a clinical study. The evaluation focused on safety and comparability to predicates.

4. Adjudication method for the test set:

• Not applicable/Not specified. This is not a study requiring adjudication of expert interpretations.

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. This device is a resorbable membrane, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

• Not applicable. This is a medical device (collagen membrane), not an algorithm.

7. The type of ground truth used:

• For safety/biocompatibility: The ground truth was established by adherence to recognized standards (FDA Blue Book Memorandum G95-1 and ISO 10993-1).
• For technical characteristics comparison: The "ground truth" was a comparison to the established characteristics of the predicate devices. The document implies that the predicate devices' characteristics serve as the benchmark for "similarity."

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense. The "training" or development would involve laboratory and animal studies, but not a "training set" of data for an algorithm.

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

• Not applicable. As above, there is no "training set" for an algorithm. The development and verification process involved established laboratory and animal testing methods to ensure the materials met safety and performance criteria, which could be considered forms of "ground truth" for the material properties.

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