(291 days)
THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA). THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency. THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.
The provided document is a 510(k) summary for "THE Graft Bone Substitute". It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and detailed study results for standalone performance.
Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific effect sizes, training set size, and detailed ground truth establishment for the training set, is not available within this document. This document is a summary of regulatory submission, not a scientific publication detailing performance studies.
However, based on the information available, here's what can be extracted:
Acceptance Criteria and Reported Device Performance
The document states, "All of the acceptance criteria were met" for the performance data. While the specific numerical acceptance criteria for each test are not explicitly detailed, the studies conducted and their purpose are mentioned. The general acceptance criterion is compliance with the referenced standards and guidance documents.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ASTM F1581 Standard Specification | Meets requirements of ASTM F1581 |
| Biocompatibility according to ISO 10993-1, -3, -5, -6, -10, -11 | Passed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation Test, Pyrogen Testing |
| Sterilization according to ISO 11137-1 | Sterilized with gamma radiation (minimum 25 kGy), SAL 10^-6, Sterilization Validation (ISO 11137-2), Endotoxin Test, Packaging Validation passed |
| Viral Inactivation | Complete inactivation of viruses demonstrated |
| In-vivo performance (dog model) and Clinical Evaluation | Performed, and "All of the acceptance criteria were met." |
Study Details
1. Sample sizes used for the test set and data provenance:
- Not explicitly stated in the provided document. The document mentions "in-vivo dog model" and "Clinical data" were provided but does not specify the number of animals or human subjects, nor their geographical origin.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not explicitly stated. For mechanical, physical, biocompatibility, and sterilization tests, the "ground truth" is typically defined by adherence to established international standards (e.g., ASTM F1581, ISO 10993, ISO 11137). For the in-vivo and clinical evaluations, the ground truth would be determined by the study's endpoints (e.g., bone formation, material resorption) assessed by qualified personnel, but the number and qualifications of experts involved in this assessment are not provided.
3. Adjudication method for the test set:
- Not applicable / Not explicitly stated. This type of adjudication (e.g., 2+1) is typically relevant for studies involving subjective human interpretation of data (e.g., imaging reads). The performance data cited are primarily objective laboratory and animal/clinical study results.
4. 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 device is a bone substitute material, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (bone substitute), not an algorithm or software. Its "standalone performance" refers to its inherent physical, chemical, and biological properties, which were assessed through the listed performance tests (mechanical, physical, biocompatibility, sterilization, viral inactivation) and in-vivo/clinical evaluations.
6. The type of ground truth used:
- For Mechanical and Physical testing: Compliance with ASTM F1581 Standard Specification.
- For Biocompatibility testing: Compliance with ISO 10993 series of standards.
- For Sterilization: Compliance with ISO 11137-1 and ISO 11137-2.
- For Viral Inactivation: Successful inactivation of viruses, which would be measured against specific validated viral assays.
- For In-vivo dog model and Clinical data: Likely pathology (histological assessment of bone formation and material resorption) and potentially outcomes data (e.g., successful integration, absence of adverse events). The specific endpoints are not detailed.
7. The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical medical device and not a machine learning model.
8. How the ground truth for the training set was established:
- Not applicable. As above, 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.