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The FOUNDATION device is a collagen-based bone filling augmentation material for use in filling of extraction sockets.

The FOUNDATION bone filler device is a sponge-like absorbable natural collagen plug designed to be used as indicated. FOUNDATION consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis.

The provided text is a 510(k) summary for the FOUNDATION device, a collagen-based bone filling augmentation material. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria for a new device.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about standalone algorithm performance (as this is a medical device, not an AI/algorithm-based one).
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The core of this submission is to show that the new FOUNDATION device is substantially equivalent to an existing FOUNDATION predicate device, with the primary difference being the country source for the bovine raw material. The submission asserts that "Appropriate controls and validations assure there is no effect on the safety, performance, and thus substantial equivalence of the new FOUNDATION compared to the predicate." This implies that the performance expectations are met by demonstrating the raw material change does not alter the established safety and performance of the predicate device, rather than through new performance metrics against specific criteria.

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