(441 days)
OCS-BTM cancellous and cortical granules are recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of defects after root resection; apicoectorny, and cystectorny
- 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 (GBR)
OCS-B™ is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Standard (as implied by comparison to predicate) | OCS-B™ Reported Performance |
|---|---|---|
| Intended Use | Used as an adjective therapy in restoring bony defects | Used as an adjective therapy in restoring bony defects |
| Target Population | Human Oral, Periodontal | Human Oral, Periodontal |
| Dosage Form | Granules contained in single use container | Granules contained in single use container |
| Granule Sizes | 0.25mm to 1.0mm or 1.0mm to 2.0 mm granules | 0.2mm to 1.0mm or 1.0mm to 2.0 mm granules |
| Material | Anorganic derived osteoconductive hydroxyapatite bone mineral | Anorganic derived osteoconductive hydroxyapatite bone mineral |
| Source Bone | Bovine bone | Bovine bone |
| Physical Morphology | Trabecular, interconnecting macro and micro pores | Trabecular, interconnecting macro and micro pores |
| Biocompatibility | Biocompatible (as demonstrated in published literature) | Biocompatible, demonstrated by a full range of tests (genotoxicity, intracutaneous reactivity, maximization/sensitization, pyrogen, acute systemic toxicity, cytotoxicity, implantation, preclinical safety/efficacy, clinical case studies) |
| Performance (Bone Formation) | Bone formation | Bone formation (demonstrated in animal studies and clinical case series) |
| Compatibility with other devices | Can be used with GTR membrane | Can be used with GTR membrane |
| Sterilization Process | Sterile by Gamma irradiation | Sterile by Gamma irradiation (SAL 1 x 10^-9 maintained) |
| Chemical Composition | Similar to predicate | Similar to Bio-Oss® based on chemical analysis, XRD, FT-IR, and ICP analysis |
| Anatomical Sites | Oral, Periodontal | Oral, Periodontal |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | Determined by Manufacturer (predicate) | 3 years |
| Risk Factors | Controlled risks similar to predicate | Controlled risks demonstrated by TSE inactivation process validation, virus clearance study, analysis of residual solvent, risk analysis, cleaning validation |
The study that proves the device meets the acceptance criteria is a compilation of data supporting substantial equivalence to the predicate device, Bio-Oss®. Specifically, the submission highlights:
- Chemical and Physical Characterization: OCS-B™ and Bio-Oss® were found to be comparable in their physical and chemical characteristics.
- Animal Studies: Multiple animal studies showed both products promoted new bone growth and were resorbed at similar rates.
- Clinical Case Series: A summary of seven individual case studies demonstrated defect healing and new bone formation sufficient for dental implant placement using OCS-B™.
- Biocompatibility Testing: OCS-B™ underwent a full range of biocompatibility tests according to FDA's "Class II Special Controls Guidance Document: Dental Bone Grafting Devices" and ISO 10993.
- Risk Control Measures: Validation of TSE inactivation, virus clearance, analysis of residual solvent, risk analysis, and cleaning validation were conducted.
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- Clinical Case Studies: 7 individual case studies for OCS-B™.
- Animal Studies: "Several animal studies" were conducted. The exact number of animals or studies is not specified.
- Biocompatibility Testing: Not specified, but a full range of tests indicates multiple samples/groups would have been used for each test.
- Data Provenance:
- The document implies data was generated directly by the sponsor or their contracted labs for OCS-B™.
- The origin (e.g., country) of the animal studies and biocompatibility testing is not specified.
- The clinical case studies are presented. While the country isn't explicitly stated, the sponsor is based in Korea.
- The data is retrospective for the clinical case series, as they are presented as a summary of existing cases rather than from a prospective clinical trial. The animal studies and biocompatibility testing would have been specifically conducted for the submission, making them prospective in nature.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Clinical Case Studies:
- Experts: Not explicitly stated how many experts established the ground truth. However, the report mentions "histological evaluation" and "radiographs," implying examination by qualified dental/medical professionals.
- Qualifications: Implied to be dental/medical professionals capable of interpreting radiographs and performing histological evaluations for assessing bone growth and defect healing. Specific qualifications (e.g., years of experience, specific certifications) are not detailed in the summary.
- Animal Studies: The experts involved in assessing bone growth and resorption in animal studies are not specified.
4. Adjudication Method (Test Set)
- Adjudication Method: Not specified for any of the studies mentioned. The clinical case series provides "histological and radiographic images demonstrate new bone growth," suggesting perhaps a single expert's assessment per case or an internal review without explicit mention of formal adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through physical/chemical comparison, animal studies, and a clinical case series, rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only)
- No, a standalone (algorithm only) performance study was not done. The device (OCS-B™) is a physical bone grafting material, not an AI algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
- Clinical Case Studies:
- Expert Consensus/Pathology/Imaging Data: Ground truth was established through a combination of histological evaluation (pathology) from core biopsies and interpretation of radiographs (imaging data), confirming new bone growth and defect healing.
- Animal Studies: Ground truth for bone growth and resorption would have been based on similar methodologies, including histological analysis and potentially imaging or quantitative analysis of bone volume.
- Biocompatibility Studies: Ground truth is based on established biological endpoints and validated assays (e.g., cell viability, immune response, genotoxicity, systemic toxicity, implantation site reaction).
8. Sample Size for the Training Set
- Not Applicable. OCS-B™ is a physical bone grafting material, not a software algorithm that requires a "training set" in the context of machine learning. The studies described are for validation and characterization of the material itself.
9. How Ground Truth for the Training Set was Established
- Not Applicable. As mentioned above, this is a physical medical device, not an AI/ML algorithm requiring a training set.
§ 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.