(224 days)
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.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.