(13 days)
OsteoGraf/D-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
The OsteoGraf/D-300 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.
The provided text is a 510(k) summary for the OsteoGraf/D-300 bone grafting material. This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than on a study proving the device meets specific performance acceptance criteria through clinical or AI-based evaluations.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-driven devices, cannot be found in this 510(k) summary.
Here's an breakdown of what can be extracted and what is not available based on your request:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not define specific quantitative acceptance criteria or provide performance metrics (e.g., sensitivity, specificity, accuracy) for the OsteoGraf/D-300. The device is a bone grafting material, and its approval is based on substantial equivalence to an existing predicate device (OsteoGraf/P, K891173).
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Available: This type of information would be relevant for a study evaluating a diagnostic device or an AI model. For a bone grafting material seeking 510(k) clearance, performance is typically demonstrated through biocompatibility, material characterization, and comparison to a predicate, not through a "test set" in the sense of a diagnostic evaluation. The summary states, "the performance data provided," but does not detail what this data entails or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Available: Ground truth in this context (for a material) is not established by a panel of experts in the way it would be for a diagnostic image or clinical outcome assessment.
4. Adjudication method for the test set
- Not Applicable/Not Available: No test set or adjudication method is described.
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 type of study is relevant for AI-assisted diagnostic devices. The OsteoGraf/D-300 is a physical bone grafting material, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device is not an algorithm.
7. The type of ground truth used
- Not Applicable/Not Available: The concept of "ground truth" as pathology, outcomes data, or expert consensus used for evaluating diagnostic performance does not apply directly to the clearance of a bone grafting material. The "truth" for this device relates to its material properties, biocompatibility, and clinical performance as observed in studies for the predicate device, but these are not detailed as "ground truth" in this context.
8. The sample size for the training set
- Not Applicable/Not Available: There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable/Not Available: No training set.
Summary of available information relevant to regulatory submission principles:
- Device Approval Type: 510(k) Premarket Notification.
- Basis for Clearance: Substantial Equivalence to a predicate device.
- Predicate Device: OsteoGraf/P, K891173.
- Key Argument for Equivalence: "All of the components found in OsteoGraf/D-300 have been used in legally marketed devices and/or were found safe for dental use. The modifications made to the legally marketed device do not affect biocompatibility."
- Intended Use Claimed: Identical to the predicate device.
- Performance Data Mentioned: "performance data provided" and "biocompatibility support", but specific details or metrics are not included in this summary.
In essence, this document is a regulatory announcement demonstrating that a new medical device is sufficiently similar to an already approved device that it does not require a new, extensive clinical trial demonstrating novel performance against defined acceptance criteria.
§ 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.