(403 days)
a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.
«-BSM™ Bone Substitute Material Kit is a synthetic, calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, to reduce alveolar bone pocket depth and increase alveolar bone thickness and height, to aid in gain in clinical attachment and for repair of cysts or other defects in the alveolar ridge or wall. &-BSM™ Bone Substitute Material Kit is provided in dry white powder form, it contains no pvrophosphates or amorphous tricalcium phosphate. The device is mixed with sterile water or saline just prior to its application to the desired periodontal defect.
The provided text describes a 510(k) summary for a medical device (α-BSM™ Bone Substitute Material Kit) and focuses on its substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria and a study demonstrating achievement of those criteria.
Therefore, many of the requested sections regarding detailed study design (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details) are not available in the provided document.
Here's an analysis of what is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance/Compliance |
|---|---|---|
| Biocompatibility | Absence of adverse reactions to tissues/body. | Tested for: Skin Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Rabbit IM. (Results are not detailed beyond "Testing... designed to... assure the biocompatibility.") |
| Material Composition | Conformance to established material standards for ceramic hydroxylapatite for surgical use. | Demonstrated through: Elemental analysis, x-ray diffraction (XRD), Fourier Transform Infrared (FTIR) Spectroscopy. Conforms to ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use. |
| Sterility | Device must be sterile. | Sterility testing (USP 23) demonstrated that the material is sterile. |
| Physical/Chemical Purity | Absence of pyrophosphates or amorphous tricalcium phosphate. (This is a product characteristic, not a test) | Device contains no pyrophosphates or amorphous tricalcium phosphate. |
| Substantial Equivalence | Similar performance and indications for use as legally marketed predicate devices. | Reviewed by FDA and deemed substantially equivalent to OsteoGen® (Impladent, Ltd.) and HAPSET® (Lifecore Biomedical). "All three products are forms of apatitic calcium phosphate with similar performance in the body." The 510(k) clearance itself is the ultimate "report" of meeting this criterion. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "Testing of x-BSM™ Bone Substitute Material was designed to characterize the finished material and assure the biocompatibility of the device," but does not detail sample sizes, study design (retrospective/prospective), or data provenance for these tests. This is typical for a 510(k) where the focus is on substantial equivalence based on material properties and basic safety, rather than clinical performance trials with controlled test sets.
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/Not provided. No clinical test set requiring expert ground truth is described. The 'testing' refers to material characterization and biocompatibility assays, not diagnostic or clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical test set requiring adjudication is described.
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 device is a bone substitute material, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a bone substitute material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the material and biocompatibility testing, the "ground truth" was based on:
- Biocompatibility Standards: Established guidelines for biological response to materials.
- Material Standards: ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use.
- Sterility Standards: USP 23 (United States Pharmacopeia).
- For the substantial equivalence claim, the "ground truth" was the performance and properties of the predicate devices (OsteoGen® and HAPSET®) and the regulatory framework that deems devices with similar characteristics and indications as equivalent.
8. The sample size for the training set
- Not applicable/Not provided. There is no "training set" in the context of this device and testing. The device is a material, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set, this question is not relevant.
§ 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.