(97 days)
Unigraft® is indicated for the repair of dental intraosseous and oral/maxillofacial defects, including: augmentation of the alveolar ridge, filling of infrabony periodontal defects, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of the maxillary sinus floor, filling of defects after cystectomy, apicoectomy and root resection, filling of periodontal and peri-implant defects in conjunction with products intended for GTR and GBR procedures, and filling of maxillofacial osseous cavities
Unigraft is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.
This document is a 510(k) summary for a medical device called Unigraft, which is a synthetic bone graft material. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.
Based on the provided text, a formal study demonstrating the device meets specific acceptance criteria was not included in this 510(k) summary. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria.
The 510(k) submission states: "The Unigraft device is substantially equivalent to devices currently in US commercial distribution, which are classified as endosseous implants for bone filling and augmentation. Examples of such products include Unigraft®, PerioGlas® and Osteograf®. These products are made of bioceramic materials with similar performance." This indicates that the device's acceptable performance is inferred from the established performance of its predicate devices, which are already on the market.
Therefore, many of the requested details about acceptance criteria and a specific study directly proving those criteria are not provided in this document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
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A table of acceptance criteria and the reported device performance
- Not provided within this 510(k) summary. The document asserts "similar performance" to predicate devices, but does not present a table of specific quantitative acceptance criteria or reported performance metrics for Unigraft itself.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. No specific test set or study data is presented in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. No ground truth establishment for a test set is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No test set or adjudication is mentioned.
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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 and not provided. This device is a bone graft material, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not provided. This device is a bone graft material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. There is no mention of a specific ground truth for performance evaluation of Unigraft in this summary. Its "performance" is implicitly tied to that of its predicate devices.
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The sample size for the training set
- Not applicable and not provided. This is not an AI/algorithm-based device and therefore doesn't have a training set in that context.
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How the ground truth for the training set was established
- Not applicable and not provided. Same as above.
Summary of available information:
The 510(k) summary for Unigraft primarily focuses on:
- Device Description: Synthetic bioactive glass granules for oral/maxillofacial and dental intraosseous defects.
- Predicate Devices: Unigraft®, PerioGlas® and Osteograf®, which are also bioceramic materials with similar performance.
- Intended Use: Repair of various dental and oral/maxillofacial defects (e.g., alveolar ridge augmentation, filling extraction sockets, sinus floor elevation).
- Basis for Acceptance: Substantial equivalence to already legally marketed predicate devices, implying similar performance and safety profiles. The document does not contain specific data from a performance study for K092567 showing an explicit comparison against predefined 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.