(83 days)
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
Bond Bone™ is a synthetic ostcoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
The provided text is a 510(k) summary for the Augma Biomaterials, Ltd. Bond Bone™ device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary requirement for 510(k) clearance. It does not typically include detailed performance studies with acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes for test/training, expert adjudication, MRMC studies, or standalone algorithm performance). These types of studies are more common for devices that rely heavily on AI/ML or new and complex technologies requiring extensive performance validation against a defined ground truth.
Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text. The document indicates that the device is a "synthetic osteoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form" and its "equivalence to marketed product" was demonstrated for FDA's purposes. This means its performance was likely evaluated through comparison to already approved similar bone grafting materials, not through the kind of structured performance study that would generate the data you're asking for.
§ 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.