(42 days)
Endobon is used in the following dental and/or oral surgical procedures :
- alveolar ridge augmentation/reconstruction
- filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall
- filling of periodontal bone pockets in the jaw (granules I)
- filling bone defects after apicetomy
- filling alveoli after tooth extraction
This product should not be used in non-periodontal mandibular applications.
Endobon is available in pre-formed shapes (i.e. blocks or cylinders) and granules sizes. This material is intended to fill voids or defects in bone and should not be used in nonperiodontal mandibular applications. Endobon is a porous hydroxyapatite ceramic made from bovine cancellous bone. Hydroxyapatite (pentacalcium hydroxide [tris] phosphate) is both the main constituent of this ceramic bone substitute and a major constituent of the inorganic phase of human and animal bone. Endobon is considered nonresorbable and is used to permanently fill or reconstruct bony defects.
The provided text is a 510(k) summary for the Endobon device, a porous hydroxyapatite ceramic used as a bone substitute. It describes the device, its intended uses, and asserts its biocompatibility and effectiveness based on preclinical and clinical studies. However, it does not contain the specific details required to complete your request for acceptance criteria and a detailed study description.
Here's a breakdown of why and what information is missing:
- Acceptance Criteria and Reported Performance Table: The document states "The efficacy of Endobon® is based on biomechanical testing and clinical documentation. Clinical, radiologic, and histologic findings from clinical trials demonstrate the biocompatibility of Endobon® and confirmed its suitability for the desired indications." This is a high-level statement but does not provide specific quantitative acceptance criteria (e.g., bone density increase by X%, fusion rate of Y%) or the numerical performance results against those criteria.
- Sample Size and Data Provenance for Test Set: The document mentions "over five years of clinical experience" and "clinical trials" but does not specify the sample size of these trials for a test set, nor the country of origin, or if they were retrospective or prospective.
- Number of Experts and Qualifications for Ground Truth: There is no mention of independent experts used to establish ground truth in any clinical study, their number, or their qualifications.
- Adjudication Method: The document does not describe any adjudication methods used for a test set.
- MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size related to human readers improving with or without AI assistance. This is likely because the device is a bone substitute, not an AI diagnostic tool.
- Standalone Performance Study: The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here as Endobon is a physical implant, not a software device or AI.
- Type of Ground Truth Used: While it mentions "clinical, radiologic, and histologic findings," it doesn't specify how these were integrated or prioritized to form a definitive "ground truth" for evaluating the device's efficacy. For example, was a specific histology finding paramount, or a composite score?
- Sample Size for Training Set: The document does not discuss a training set, as it pertains to AI/machine learning models, which is not applicable to this medical device.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, the provided 510(k) only offers a general affirmation of safety and effectiveness based on existing studies and clinical experience, but it lacks the granular detail about specific study designs, acceptance criteria, and performance metrics that your request asks for. This level of detail is typically found in the full clinical trial reports or FDA review memoranda, which are not part of the publicly available 510(k) summary.
§ 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.