(267 days)
THE Cover is recommended for:
- Covering of immediate or delayed extraction socket to enhance preservation of the alveolar ridge.
THE Cover Resorbable Collagen Membrane is a white, pliable membrane consisting of fibrous collagen matrix purified from porcine tendon. THE Cover act as a barrier between the gingival and the new bone that can facilitate proper bone regeneration. As soft tissues tend to grow faster than the bone can regenerate, the membrane can help protect the bone graft particles from this faster growing connective tissue. As collagen membrane will be dissolved, no additional operation is necessary. THE Cover does not have a distinction between face and back.
The provided text describes the regulatory clearance of a medical device called "THE Cover" and details the studies conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain information related to an AI/Software as a Medical Device (SaMD) or an algorithm.
Therefore, I cannot provide an answer to your request as it pertains to AI/SaMD acceptance criteria and studies demonstrating algorithm performance. The document focuses on the physicochemical, mechanical, biocompatibility, and in vivo performance of a physical bone grafting material (collagen membrane), not an AI algorithm.
If you have a document about an AI/SaMD, please provide it, and I will be happy to answer your questions regarding acceptance criteria and study details.
§ 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.