(207 days)
OssGuide is recommended for:
- Simultaneous use of GBR-membrane (OssGuide) and implants;
- Augmentation around implants placed in immediate extraction sockets;
- Augmentation around implants placed in delayed extraction sockets;
- Localized ridge augmentation for later implantation;
- Alveolar ridge reconstruction for prosthetic treatment;
- Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth;
- Guided bone regeneration in dehiscence defects
OssGuide (Absorbable collagen membrane) is made of purified collagen without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The OssGuide is a collagen membrane obtained by a standardized controlled manufacturing process. The OssGuide has a porous and fibrous microstructure that prevents the ingrowth of fibrous tissue into the bone defect. OssGuide functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. OssGuide is substantially resorbed within 24 weeks after implantation.
The provided text is a 510(k) Summary for the medical device OssGuide, a bone grafting material. This summary focuses on demonstrating substantial equivalence to a predicate device, not on presenting acceptance criteria and a study proving the device meets those criteria in terms of algorithm performance for an AI/ML powered device.
Therefore, the information required to answer the prompt (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not available in the provided document.
This document describes a conventional medical device (a collagen membrane for bone regeneration) and its non-clinical testing for safety and equivalence to an existing product, not an AI-powered diagnostic or therapeutic device.
§ 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.