(78 days)
Unigraft is indicated for use in infrabony defects caused by periodontal diseases.
UniGraft is a synthetic bioactive glass material used for the treatment of bony defects caused by periodontal diseases. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.
The bioglass used in UniGraft is one of the most extensively studied bioactive glass compositions, and has been shown to bond to bone as well as soft tissue. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite in bone mineral. This apatite layer provides the bonding interface with bone and certain types of soft tissue.
This K982699 document is a 510(k) summary for a synthetic bone graft material called UniGraft. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding an "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in the provided text.
Here's an breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (as stated in the summary) |
|---|---|
| Biocompatibility | "assured the biocompatibility of the device" |
| Material Characteristics (e.g., FT-IR, XRD, EDX) | "The results of these tests demonstrate that the UniGraft device is substantially equivalent to a predicate device." |
| Bioactivity Response | "The results of these tests demonstrate that the UniGraft device is substantially equivalent to a predicate device." |
| Substantial Equivalence to Predicate Devices (PerioGlas, Biogran) | "The UniGraft device is substantially equivalent to devices currently in US commercial distribution," and "with similar performance." |
Explanation: The document does not list explicit numerical or qualitative acceptance criteria. Instead, it states that testing was designed to "characterize the finished device and to assure the biocompatibility" and that results "demonstrate that the UniGraft device is substantially equivalent to a predicate device." The "acceptance" in this context is the FDA's determination of substantial equivalence based on the provided data.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document mentions "testing of UniGraft" and comparative evaluation against a predicate device using various test methods, but the number of units or samples tested is not provided.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the document describes characterization and comparative testing of the material itself, not a study involving human diagnosis or intervention that would require expert ground truth establishment in that manner.
4. Adjudication method for the test set
- This information is not applicable for the reasons stated above.
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
- This information is not applicable. The device is a synthetic bone graft material ("UniGraft"), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. As stated above, this is a material device, not an algorithm.
7. The type of ground truth used
- For the device's material properties, the "ground truth" would be established by standard scientific measurements (FT-IR, XRD, EDX) and bioactivity assays, likely compared against known characteristics of the predicate devices. It is based on objective scientific measurements and comparisons. No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense is mentioned for the test set of the device itself.
8. The sample size for the training set
- Not applicable / Not specified. The document describes a medical device (bone graft material), not a machine learning model that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not specified. As there is no training set for a machine learning model, this question is not relevant.
In summary:
The provided K982699 document is for a medical device (synthetic bone graft material) seeking substantial equivalence based on material characterization and comparative performance testing against predicate devices. It is not a clinical study involving patient data, expert readers, or AI algorithms. Therefore, many of the questions related to clinical study design, ground truth establishment for diagnostic tasks, and AI performance metrics are not addressed or applicable within this regulatory submission.
§ 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.