(209 days)
Anorganic Bone Mineral with Collagen 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 with Collagen in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone with the addition of bovine type I collagen, pre-loaded 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. The type I collagen component is derived from bovine Achilles tendon. Anorganic Bone Mineral with Collagen in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.
The provided document is a 510(k) summary for the "Anorganic Bone Mineral with Collagen in Delivery Applicator" device. It describes the device, its indications for use, and a comparison with predicate devices to establish substantial equivalence. However, it does not contain information typically found in a study proving a device meets specific acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader effectiveness for an AI/ML medical device.
This document describes a bone grafting material and its delivery applicator, a Class II medical device. The focus is on demonstrating substantial equivalence to existing predicate devices through material properties, biocompatibility, sterilization, and functionality. It is not an AI/ML device, and therefore the concepts of "acceptance criteria" in the context of statistical performance metrics, "test set," "training set," "ground truth," "expert adjudication," or "MRMC studies" as they apply to AI/ML devices are not relevant here.
Therefore, I cannot provide the requested information for an AI/ML device.
Here's what I can extract based on the document's content, focusing on non-clinical performance testing:
While not in the format of AI/ML acceptance criteria, the document describes "Non-Clinical Performance Testing" which serves a similar purpose of verifying device performance.
1. A table of acceptance criteria and the reported device performance:
Since this is not an AI/ML device evaluation, the "acceptance criteria" are related to physical, chemical, and biological properties, not statistical performance metrics.
| Feature | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, non-pyrogenic, non-toxic | Sterile Finished Device: Cytotoxicity, irritation, and sensitization confirmed acceptable. |
| Delivery Applicator: Cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, physicochemical tests USP , physicochemical (material/chemical) characterization testing of non-aged and 36 month real time aged delivery applicators with extraction conditions and methods in accordance with ISO 10993-12 and ISO 10993-18. | ||
| Anorganic Bone Mineral & Purified Type I Collagen: Cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity confirmed acceptable (previously submitted). | ||
| Sterility | Sterility Assurance Level (SAL) 10⁻⁶ | Gamma irradiation, SAL 10⁻⁶ (validated in accordance with ISO 11137-1) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic (confirmed by testing) |
| Single Use | Single use only | Single Use Only (as designed) |
| Plunger Force | Specific force range for dispensing (for the delivery applicator) | 4.5 N ± 1.3 N (preformed plug) |
| 4.1 N ± 1.1 N (moldable plug) | ||
| Functionality | Successful delivery of material, ease of placement | Bench testing of delivery applicator functionality and customer assessment (results not detailed, but implied as successful for substantial equivalence). |
| Animal Performance | Acceptable integration/performance in bone regeneration models | Porcine Anorganic Bone Mineral: Intraoral defect in a canine model. |
| Anorganic Bone Mineral with and without Collagen: Rabbit femoral condyle defect model. | ||
| Purified Type I Collagen: Rat subcutaneous implantation study. (Results are implied to be acceptable for substantial equivalence, but specific metrics are not provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of an AI/ML "test set" and statistical performance. For the non-clinical testing:
- Sample sizes for biocompatibility, sterility, and pyrogenicity: Not specified in the document, but understood to adhere to relevant ISO standards (e.g., ISO 10993, ISO 11137).
- Sample size for plunger force: Not specified for how many units were tested.
- Sample sizes for animal studies: "a canine model," "a rabbit femoral condyle defect model," "a rat subcutaneous implantation study." Specific numbers of animals are not provided.
- Data provenance: Not explicitly stated, but assumed to be from internal lab studies and potentially contract research organizations. No country of origin for test data is mentioned. The studies are prospective in the sense that they were conducted for the purpose of this submission.
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. "Ground truth" in the context of an AI/ML device (e.g., disease presence/absence) is not relevant here. The "ground truth" for this device's performance is established by the direct physical, chemical, and biological testing results against predefined specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring human adjudication of performance outputs.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained, "ground truth" for AI/ML devices is not applicable. For this device, the "truth" is established by:
- Direct analytical measurements (e.g., plunger force, material composition, physicochemical tests).
- Standardized biological assays (e.g., cytotoxicity, sensitization, pyrogenicity tests).
- Histopathological and physiological observations from animal models of bone regeneration.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.