(80 days)
For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge
Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.
The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. 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 found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.
Here's an analysis of the provided 510(k) summary for the Unigraft device, addressing your specific questions.
Important Note: The provided document is a 510(k) summary for a medical device (synthetic bone graft material), not an AI/Software as a Medical Device (SaMD). Therefore, many of your questions related to AI/SaMD performance metrics, ground truth, expert adjudication, and training/test set details are not applicable to this type of submission. I will address them by stating "Not Applicable" or explaining why they don't fit.
Unigraft (K993784) - Device Acceptance Criteria and Study Details
The Unigraft device is a synthetic bioactive glass material intended for oral defect repair. Its approval is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The primary "acceptance criteria" in this context is the successful demonstration of this substantial equivalence through comparative testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| Material Composition Equivalence: Unigraft's material (45S5 Bioglass) should be the same as or comparable to predicate devices. | Unigraft utilizes "45S5 Bioglass," which is described as one of the "most extensively studied bioactive glass compositions" and the "same material is used in legally marketed devices, including BioGran® and PerioGlas®." |
| Intended Use Equivalence: Unigraft's indications for use should be substantially similar to predicate devices. | "For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge." This is consistent with devices classified as "endosseous implant for bone filling and augmentation." |
| Mechanism of Action Equivalence: Unigraft's biological interaction should be similar to predicate devices. | Describes "time dependent surface modification" resulting in a "calcium phosphate layer... equivalent... to hydroxyapatite found in bone minerals," providing an "osteo-conductive scaffold." This mechanism is characteristic of bioactive glasses in this category. |
| Performance Equivalence (Comparative Testing): Unigraft should perform comparably to predicate devices in relevant tests. | "The Unigraft device was evaluated comparatively against a predicate device using a variety of test methods. The results of these tests demonstrate that the Unigraft device is substantially equivalent to a predicate device." (Specific test types or detailed results are not provided in this summary.) |
| Safety Profile: Implied through equivalence to legally marketed devices. | Not explicitly detailed, but assumed to be acceptable given the substantial equivalence claim to devices already on the market. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided 510(k) summary. The summary only states that the device was "evaluated comparatively against a predicate device using a variety of test methods."
- Data Provenance: Not specified. It's likely pre-clinical (in vitro, in vivo animal studies) for material characterization and biocompatibility, but the origin (e.g., country, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a medical device (material) submission, not an AI/SaMD. "Ground truth" in the context of AI/SaMD for diagnostic accuracy is not relevant here. The evaluation would involve material science, biocompatibility, and potentially animal or limited human clinical studies (though not detailed here).
4. Adjudication Method for the Test Set
- Not Applicable. As above, this concept (common in AI/SaMD for resolving discrepancies among human readers) is not relevant for the type of testing described in this 510(k) summary.
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 a medical device (material) submission, not an AI/SaMD. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As above, this is not an AI/SaMD submission, so there is no "algorithm" to evaluate in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (in the AI/SaMD sense). For this type of medical device, "ground truth" would relate to verifiable material properties (chemical composition, physical structure), biocompatibility test results (e.g., ISO 10993 standards), and potentially histological evidence from animal studies showing bone ingrowth or integration. The summary does not detail the specific methods or types of ground truth used in the comparative testing.
8. The Sample Size for the Training Set
- Not Applicable. This is a medical device (material) submission, not an AI/SaMD that requires training data.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or AI model is involved.
§ 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.