(274 days)
Natural Mineral Bone Graft Substitutes are 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 periodontal defects
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products 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
"OsteoGuide™ Anorganic Bone Mineral," "OsteoGuide Collagen™ Anorganic Bone Mineral with Collagen,"and "OsteoGuide Blocks™ Anorganic Bone Mineral with Collagen Blocks" are natural, porous bone mineral matrices with and without collagen. The anorganic bone mineral is produced by removal of all organic components from bovine bone. Due to its natural structure, the anorganic bone mineral component of the OsteoGuide products is physically and chemically comparable to the mineralized matrix of human bone. The composition of OsteoGuide Anorganic Bone Mineral meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants. OsteoGuide Collagen and OsteoGuide Blocks are product extensions that include highly purified fibrillar type I collagen mixed in with the anorganic bone mineral. The product is supplied in granules or blocks, and it is sterile, non-pyrogenic, and for single use only.
The provided text describes a 510(k) premarket notification for a medical device, OsteoGuide™ Anorganic Bone Mineral Products. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy against acceptance criteria. Therefore, the information typically requested for devices requiring a standalone or comparative effectiveness study (like AI-based devices) is not present in this document.
Here's a breakdown of why and what information is available:
-
No Acceptance Criteria or Device Performance Table: The document explicitly states that the device's effectiveness is demonstrated by meeting "design requirements for an effective bone grafting material" and by the "substantial equivalence" to predicate devices. There are no specific quantitative acceptance criteria or reported device performance metrics in the way one would find for an AI algorithm (e.g., sensitivity, specificity, AUC).
-
No Study Details for Efficacy: Because this is a substantial equivalence submission, there isn't a "study" in the traditional sense to prove the device meets acceptance criteria. Instead, the "effectiveness" section states: "The characteristics of the OsteoGuide Anorganic Bone Mineral Products meet the design requirements for an effective bone grafting material." The primary evidence for effectiveness is the comparison to predicates and the material characterization.
Let's address the specific points you asked for, explaining why they are mostly not applicable or how they are addressed within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Substantial Equivalence to Predicate) | Reported Device Performance (Implied by 510(k) Substantial Equivalence and Material Characterization) |
|---|---|
| Safety: Device passes all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices. | Device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices. |
| Effectiveness: Characteristics meet design requirements for an effective bone grafting material and are "substantially equivalent" to predicate devices in intended use, material, material characterization, form, and sizes. | OsteoGuide Anorganic Bone Mineral is "physically and chemically comparable to the mineralized matrix of human bone." Composition "meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants." Characteristics are the same as predicates in intended use, material, material characterization, form, and sizes. |
| Biocompatibility: Demonstrated through in vitro and in vivo studies. | In vitro and in vivo biocompatibility studies demonstrated safety. |
| Sterility & Non-pyrogenicity: Device is sterile and non-pyrogenic. | Product is supplied as sterile and non-pyrogenic. |
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. This device is a biomaterial, not an AI algorithm. Its "performance" is assessed through material characterization and biocompatibility testing, not through a "test set" of patient data or images. The document mentions "in vitro product characterization studies, in vitro and in vivo biocompatibility studies," but does not provide sample sizes for these, as they are typically standardized tests rather than clinical trials with patient cohorts.
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. See point 2. Ground truth in the context of an AI device is typically expert consensus on medical images or diagnoses. For a bone grafting material, the "ground truth" relates to its material properties and biological response, which are assessed through laboratory tests and histological evaluations, not expert clinical reviews of a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2 and 3.
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 biomaterial, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a biomaterial, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the safety/biocompatibility evaluation, the "ground truth" would be established by the results of standardized biological tests as specified in FDA Blue Book Memorandum G95-1 and ISO 10993-1. These tests assess parameters such as cytotoxicity, sensitization, irritation, acute systemic toxicity, and implantation effects, which are objectively measured and interpreted against established criteria for biological safety.
- For the effectiveness/material characteristics, the "ground truth" is defined by the chemical and physical comparability to human bone and conformance to industry standards like ASTM F1581-99. This involves analytical chemistry techniques (e.g., elemental analysis, spectroscopy) and microscopic evaluation to ensure the material properties match the requirements and the predicate devices.
8. The sample size for the training set
- Not Applicable. This is a biomaterial. There is no concept of a "training set" as there would be for an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.