(298 days)
Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)
Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.
The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.
It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.
The provided document is a 510(k) summary for a medical device called "Synthetic Bone Graft Particulate." It focuses on demonstrating substantial equivalence to a predicate device ("PerioGlas - Bioglass Bone Graft Particulate") for regulatory clearance.
This document does not contain acceptance criteria or study details for an AI/ML-driven device's performance. The "performance data" section (Section 7) describes non-clinical tests (sterilization, shelf-life, biocompatibility, chemical/physical properties) and an animal study for the bone graft material itself, not for an AI/ML system.
Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device. The device described in the document is a physical medical implant (synthetic bone graft particulate), not an AI/ML software or system.
§ 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.