(126 days)
Geistlich Bio-Oss® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of infrabony periodontal defects;
- Filling of defects after root resection, apicoectomy, and cystectomy;
- Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral. The product is provided in granules or block form. Geistlich Bio-Oss® serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous, hydrophilic and has a large inner surface area. Geistlich Bio-Oss® is provided sterile via gamma irradiation or x-ray irradiation.
This FDA 510(k) summary describes a bone grafting material, Geistlich Bio-Oss®, and its claim of substantial equivalence to a predicate device. The document focuses on the technical characteristics and performance data related to manufacturing changes rather than software or AI performance.
Therefore, many of the requested categories related to AI/software performance, such as MRMC studies, effect size of human improvement with AI, standalone algorithm performance, training set details, and adjudication methods for AI performance, are not applicable or cannot be extracted from this document.
Here's the information that can be extracted, with "N/A" for sections not covered by the provided text:
Acceptance Criteria and Study for Geistlich Bio-Oss®
| Acceptance Criteria Category | Reported Device Performance / Study Details |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Device being evaluated: Geistlich Bio-Oss® Predicate Device: Geistlich Bio-Oss® (K122894) Reference Device: Orthoss® (K190754) |
The core acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device, specifically showing that changes (alternative sterilization method, new raw material supplier, new volumes) do not raise different questions of safety and effectiveness.
Reported Performance (Comparison of Technological Characteristics):
- Material: Subject Device: Mineral of bovine origin; Predicate: Mineral of bovine origin. (Same)
- Shape: Subject Device: Granules, Block; Predicate: Granules, Block. (Same)
- Particle Sizes: Subject Device: 0.25 - 1.0, 1.0 - 2.0; Predicate: 0.25 - 1.0, 1.0 - 2.0. (Same)
- Configurations (Volumes): Subject Device has additional volumes (0.125 g, 1.0 g in both particle sizes) compared to the Predicate. (Different)
- Single-Use: Subject Device: Yes; Predicate: Yes. (Same)
- Sterilization: Subject Device: Gamma, X-ray; Predicate: Gamma. (Different)
Performance Data used to support substantial equivalence:
- Sterilization: Validation per ISO 11137-1, ISO 11137-2, and ISO 11137-3 (for the new x-ray sterilization method).
- Biocompatibility: Assessments per ISO 10993-1 and ISO 10993-5 (leveraged from K190754).
- Stability/Shelf-life: Stability testing per ICH Q1A (R) guidelines (leveraged from K190754) and extended from 3 to 4 years.
- Structural and Mechanical Properties: Characterization performed (leveraged from K122984).
- Viral Inactivation: Studies per ISO 22442-3 and ICH Q5A(R2) Draft Version.
- Raw Material Validation: Validation of raw materials from the new supplier, characterized by physical and chemical composition and appearance using the same tests and acceptance criteria as the final finished product.
Conclusion: The submission concludes that the changes do not raise different questions of safety and effectiveness, and thus Geistlich Bio-Oss® is substantially equivalent to the identified predicate device based on these performance evaluations. |
| 2. Sample Size (Test Set) & Data Provenance | N/A - This document describes testing for a bone graft material, not a diagnostic or AI device with a "test set" in the traditional sense of patient data. The "samples" would refer to manufacturing batches or material samples used for physical, chemical, and biological testing. The document does not specify exact numbers of batches/samples for each test but indicates validation of raw materials from a new supplier from New Zealand and Australia. |
| 3. Number of Experts & Qualifications | N/A - Not applicable for this type of device and submission. Expert panels are typically used for establishing ground truth in diagnostic accuracy studies, which is not the focus here. |
| 4. Adjudication Method | N/A - Not applicable. |
| 5. MRMC Comparative Effectiveness Study | N/A - This device is a bone grafting material, not an AI or diagnostic tool that involves human readers or MRMC studies. |
| 6. Standalone Algorithm Performance | N/A - This document does not describe an algorithm or software device. |
| 7. Type of Ground Truth Used | The "ground truth" here refers to established scientific/engineering principles and validated methods for assessing material safety and performance. This includes:
- International Standards: ISO 11137 series (sterilization), ISO 10993 series (biocompatibility), ISO 22442-3 (viral inactivation).
- ICH Guidelines: ICH Q1A (R) (stability), ICH Q5A(R2) (viral inactivation).
- Predicate Device Performance: The predicate Geistlich Bio-Oss® (K122894) and reference Orthoss® (K190754) and their previously demonstrated safety and effectiveness serve as the established benchmark.
- Characterization Data: Physical and chemical characterization of the material itself. |
| 8. Sample Size for Training Set | N/A - No training set as this is not an AI/software product. |
| 9. Ground Truth for Training Set | N/A - No 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.