(455 days)
Bone Plus™ BCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
- 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
Bone Plus™ BCP is a synthetic resorbable osteo-conductive bone graft substitute composed of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (beta-TCP). Bone Plus™ BCP presents a interconnected porosity structure, similar to that of human cancellous bone. It is supplied sterile and it is dedicated for single use.
Here's the breakdown of the acceptance criteria and the study information for the Bone Plus™ BCP device, based on the provided text:
Important Note: The provided text is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed scientific paper on a clinical trial. Therefore, much of the information typically found in a study proving device performance (like specific statistical metrics, detailed ground truth establishment for a test set, expert qualifications, or MRMC studies) is not present. The purpose of a 510(k) summary is to demonstrate equivalence to a predicate device, often through non-clinical testing and comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Material Composition | 60% HA and 40% Beta-TCP (similar to predicates) | Comprised of 60% Hydroxyapatite (HA) and 40% Beta Tricalcium Phosphate (β-TCP) |
| Physical Characteristics | Interconnected porosity similar to human cancellous bone | Presents an interconnected porosity structure, similar to that of human cancellous bone |
| Sterility | Sterile | Supplied sterile |
| Single Use | Dedicated for single use | Dedicated for single use |
| Biocompatibility | No adverse tissue reactions (implied by predicate history) | (Not explicitly detailed, relies on substantial equivalence to predicates) |
| Resorbability | Resorbable (implied by predicate function) | Synthetic resorbable osteo-conductive bone graft substitute |
| Functionality/Performance | Fill, augment, or reconstruct periodontal/bony defects as intended. Must perform comparably to predicate devices in: |
- Histomorphometric Evaluation
- Chemical and Physical Analysis
- Porosity assessment
- Solubility | "Testing and other comparisons have established that the subject of Bone Plus™ BCP substantially equivalent in design, materials, indications and intended use, and performance to other predicate devices of the type currently marketed in the U.S."
Studies performed: - Histomorphometric Evaluation of Bone Plus™ BCP
- Chemical and Physical Analysis of Bone Plus™ BCP
- Porosity assessment of Bone Plus™ BCP
- Solubility Test of Bone Plus™ BCP
- Clinical Study of Bone Plus™ BCP |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions a "Clinical Study of Bone Plus™ BCP" but does not provide details on its sample size, methodology, or results. Given the context of a 510(k), this study was likely supportive evidence for substantial equivalence rather than a full-scale clinical trial with a defined test set for performance metrics.
- Data Provenance: Not specified for the "Clinical Study." The manufacturer is MegaGen Implant Co., Ltd. from South Korea, so it's possible the clinical data originated there, but this is not confirmed. It's also not specified if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not specified. The 510(k) summary does not provide details on how "ground truth" was established for any clinical or performance studies, nor does it mention the involvement of experts in that capacity.
4. Adjudication Method for the Test Set
- Not specified. No information is provided regarding adjudication methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study is not mentioned or implied. The document focuses on demonstrating substantial equivalence to predicate devices through various technical and likely non-clinical evaluations, along with a mention of a "Clinical Study," the details of which are not provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is not applicable. The device is a bone grafting material, not a software algorithm or AI-powered diagnostic tool. Performance is assessed through material properties, biological interaction, and clinical outcomes, not an "algorithm-only" evaluation.
7. The Type of Ground Truth Used
- For the technical and material characterization studies (histomorphometric, chemical, physical, porosity, solubility), the "ground truth" would be established by standard analytical methodologies, laboratory measurements, and histological examination by qualified personnel (e.g., histologists, materials scientists).
- For the "Clinical Study," the nature of the ground truth is not specified, but it would typically involve clinical assessments, radiographic evidence, and potentially histological analysis of biopsies from the implantation sites, interpreted by clinicians or pathologists. The document implies comparison to clinical outcomes of the predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical medical implant (bone graft material), not a machine learning model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable, as 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.