(134 days)
Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge
- Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Anorganic Bone Mineral in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone without the addition of bovine type I collagen, preloaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.
The document describes a 510(k) premarket notification for a medical device called "Anorganic Bone Mineral in Delivery Applicator". It does not describe a study involving an algorithm or AI.
Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set sample size, ground truth for training set) are not applicable to this document.
However, I can provide the acceptance criteria and demonstrated performance based on the non-clinical testing described.
1. Table of acceptance criteria and the reported device performance
| Feature | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Material/Source | Bovine Bone, Anorganic Bone Mineral | Bovine Bone (anorganic bone mineral) |
| Composition | 100% Anorganic Bone Mineral Granules | 100% Anorganic Bone Mineral Granules |
| Particle Size | 0.25 - 1.0 mm | 0.25 - 1.0 mm |
| Biocompatibility | Biocompatible (based on ISO standards) | Biocompatible (demonstrated by testing) |
| Sterility | Gamma irradiation, SAL 10^-6 | Gamma irradiation, SAL 10^-6 (validated based on ISO 11137-1) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use | Single Use Only | Single Use Only |
| Plunger Force | Not explicitly defined as "acceptance criteria", but a performance measure for the delivery applicator | 8.18 ± 3.8 N (measured for the subject device) |
Additional Non-Clinical Performance Testing:
- Biocompatibility of Sterile Finished Device: Cytotoxicity, irritation, and sensitization tests were performed and demonstrated biocompatibility. (Specific acceptance criteria for these individual tests are not detailed, but the conclusion states they were met.)
- Biocompatibility of Delivery Applicator: Cytotoxicity, physicochemical attributes of a polymeric material, and USP physicochemical tests were performed. (Specific acceptance criteria not detailed, but the conclusion states they were met.)
- Biocompatibility of Anorganic Bone Mineral: Cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, and subacute/subchronic toxicity tests were performed. (Previously submitted and deemed applicable, conclusion states they were met.)
- Sterilization Validation: Performed in accordance with ISO 11137-1. (Implies meeting the SAL 10^-6 requirement.)
- Bench Testing of Delivery Applicator Functionality and Customer Assessment: Performed. (Implies proper functioning of the applicator.)
- Animal Performance Testing:
- Anorganic Bone Mineral (derived from porcine bone tissue): Tested in an intraoral defect in a canine model.
- Anorganic Bone Mineral with and without Collagen: Tested in a rabbit femoral condyle defect model.
(These studies supported the performance of the bone mineral component, which is part of the subject device.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study. The relevant "tests" involved laboratory-based biocompatibility, sterilization validation, and bench testing, as well as animal studies. The sample sizes for these specific non-clinical tests (e.g., number of animals, number of test samples for material characterization) are not detailed in this summary.
3. 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 applicable, as this document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as this document describes non-clinical performance testing not requiring a clinical "ground truth" as typically defined for diagnostic AI. The "ground truth" for these tests would be the established scientific standards and methods for assessing material properties, biocompatibility, and sterility.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
§ 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.