(88 days)
The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.
OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.
This document, K960348, is a 510(k) summary for a medical device (OsteoGraf/N-300 Hydroxylapatite) from 1996. It describes the device's characteristics, intended use, and comparison to a predicate device.
Crucially, this document is a pre-market notification (510(k) summary) from 1996 describing the device and its conformity to a standard. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods in the context of an AI/ML device as requested in the prompt.
Therefore, I cannot provide the requested information because the provided text does not contain any information regarding the evaluation of an AI-powered device. The device described, OsteoGraf/N-300 Hydroxylapatite, is a physical implant, not a software or AI-based diagnostic tool.
Therefore, all fields in your requested table will be marked as "Not Applicable" or "Information Not Provided in Document".
Here's a breakdown of why each section cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: The document only states the device conforms to the requirements of ASTM standard #F1581. It does not provide specific acceptance criteria or performance metrics in a table format for diagnostic accuracy, sensitivity, specificity, etc., which would be relevant for an AI device.
- Sample size used for the test set and the data provenance: Not applicable, as this is not an AI device being tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.