(330 days)
PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.
PolyBone® Dental is a synthetic resorbable calcium phosphate bone grafting material which consists of 100% beta-tricalcium phosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 7585% with a 200500 um pore size. Mechanism of PolyBone Dental's bone regeneration works by bone cells resorbing dicalciumphosphate dihydrate (DCPD, brushite), which is a conversion material of ß tricalcium phosphate.
This document describes a 510(k) submission for a device called "PolyBone® Dental". The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, many of the requested details are not available in the provided text.
Here is the information that can be extracted or inferred:
1. Table of acceptance criteria and the reported device performance
No explicit acceptance criteria or quantitative performance metrics are provided in the document. The submission's goal is to demonstrate "substantial equivalence" to predicate devices, focusing on similar technological characteristics, components, indication for use, chemical properties, and performance properties.
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission based on demonstrating substantial equivalence, not a clinical trial with a test set of patient data from specific geographical locations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not discussed as this is not a study assessing diagnostic or prognostic performance based on patient data.
4. Adjudication method 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
No MRMC study was done. This device is a bone grafting material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone grafting material, not an algorithm.
7. The type of ground truth used
Not applicable in the context of a performance study for a diagnostic algorithm. The "ground truth" for this 510(k) submission is the demonstrated equivalence to legally marketed predicate devices, which implies that the predicate devices themselves are considered safe and effective.
8. The sample size for the training set
Not applicable. PolyBone® Dental is a physical medical device (bone grafting material), not an AI algorithm that requires a training set.
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.