(11 days)
OsteoGraf/D-700 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
The OsteoGraf/D-700 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.
This 510(k) summary for the OsteoGraf/D-700 focuses on demonstrating substantial equivalence to predicate devices, primarily through the established safety and effectiveness of its component materials. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria through empirical testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study designed to meet specific acceptance criteria. The document explicitly states: "We believe that the prior use of the components of OsteoGraf/D-700 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/D-700 for the indicated uses." This indicates reliance on previous approvals and material characteristics rather than new, quantitative performance studies for this specific submission.
Here's what can be inferred from the provided text, and what information is not available:
1. Table of acceptance criteria and reported device performance:
- Not Available. The document does not specify quantitative acceptance criteria or performance metrics for the device itself (e.g., bone growth percentage, defect fill rate). The acceptance criteria are implicitly tied to the safety and effectiveness demonstrated by predicate devices and the material's known properties.
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. No specific "test set" in the context of a new performance study is mentioned. The submission relies on "prior use of the components" and general "performance data provided," which likely refers to literature or historical data on the materials, not a de novo clinical or lab study for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. No panel of experts established ground truth for a new test set in this submission.
4. Adjudication method for the test set:
- Not Applicable/Not Provided.
5. 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. This is not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI-enabled device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Ground Truth: The ground truth for the device's safety and effectiveness is based on the established regulatory history and scientific understanding of its core material (hydroxylapatite) and its components as used in predicate devices. This implicitly relies on historical clinical outcomes and expert understanding of bone grafting materials.
8. The sample size for the training set:
- Not Applicable/Not Provided. No training set for a new algorithm or performance study is mentioned.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided.
Summary of available information:
- The 510(k) relies on substantial equivalence to predicate devices (K863176, K863234, K861084, K861083, K852742).
- The argument for safety and effectiveness is based on the prior use of the material's components in legally marketed devices and their known biocompatibility.
- The device is a nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, a known bone substitute material.
- The intended uses are treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites, which are the same as those cleared for predicate devices.
This type of 510(k) submission, particularly for a material-based device with a well-established predicate, often focuses on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to the approved predicates, rather than presenting new, extensive performance study data.
§ 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.