(30 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 granules. 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 and has a large inner surface area.
Geistlich Bio-Oss® is provided sterile in the following configurations:
- Geistlich Bio-Oss® spongiosa (cancellous) granules (0.125 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (0.25 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (0.5 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (1.0 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (2.0 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (5.0 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (0.5 g, particle size 1.0 – 2.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (1.0 g, particle size 1.0 – 2.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) granules (2.0 g, particle size 1.0 – 2.0 mm)
- Geistlich Bio-Oss® spongiosa (cancellous) block (approx. 1 x 1 x 2 cm)
Geistlich Bio-Oss Pen® is a pre-filled syringe-like applicator containing Geistlich Bio-Oss® granules. The pen allows for targeted delivery of Geistlich Bio-Oss® granules to the intended treatment site without the need for other sterile instruments.
Geistlich Bio-Oss Pen® is provided sterile in the following configurations:
- Geistlich Bio-Oss Pen® (filled with 0.25 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss Pen® (filled with 0.5 g, particle size 0.25 – 1.0 mm)
- Geistlich Bio-Oss Pen® (filled with 0.5 g, particle size 1.0 – 2.0 mm)
This document is a 510(k) clearance letter for a bone grafting material, Geistlich Bio-Oss® and Geistlich Bio-Oss Pen®. The core claim of the submission (K251786) is that the new devices are "substantially equivalent" to previously cleared predicate devices.
The request asks for information typically found in an FDA submission for AI/ML-enabled devices, particularly those involving diagnostic aids. This 510(k) submission, however, is for a physical medical device (bone grafting material) and does not involve AI or algorithms for diagnostics or image analysis. Therefore, many of the requested elements are not applicable to this type of traditional medical device clearance.
Here's a breakdown of the requested information based on the provided document, highlighting what is not applicable:
Acceptance Criteria and Device Performance for Geistlich Bio-Oss® and Geistlich Bio-Oss Pen® (K251786)
It is crucial to understand that this 510(k) is for a physical bone grafting material, not an AI/ML-enabled diagnostic device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices through material properties, manufacturing consistency, biocompatibility, sterilization, and basic handling characteristics, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and reader studies typically associated with AI.
The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate devices, particularly concerning the addition of an alternate raw material supplier and minor manufacturing/release testing changes, without raising new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance
For a physical bone grafting material, the "acceptance criteria" relate to material composition, physical properties, biocompatibility, sterility, and manufacturing consistency. The provided document details the comparison of characteristics to the predicate and references studies demonstrating these aspects.
| Acceptance Criteria Category (Implied by Submission) | Reported Device Performance (as described in 510(k)) |
|---|---|
| Material Composition | Identical to predicate: purified spongiosa (cancellous) bovine bone mineral granules. (New: alternate raw material supplier for bovine material, deemed not to raise new safety/effectiveness questions.) |
| Form | Identical to predicate: Granules or block form. Geistlich Bio-Oss Pen® is granules pre-filled in a syringe-like applicator. |
| Particle Size | Identical to predicate: 0.25 – 1.0 mm, 1.0 – 2.0 mm. |
| Block Size | Identical to predicate: ~1 x 1 x 2 cm. |
| Single-Use | Identical to predicate: Yes. |
| Sterilization Method | Identical to predicate: Gamma, X-ray (Geistlich Bio-Oss® only). |
| Manufacturing Methods | Non-significant changes to manufacturing facilities and equipment. Deemed not to raise different questions of safety/effectiveness. |
| Release Testing Methods | Non-significant changes to release testing methods. Deemed not to raise different questions of safety/effectiveness. |
| Biocompatibility | Leverage results from predicate/reference devices (K120601, K240661). Conforms to ISO 10993-1:2018. |
| Sterilization & Shelf-Life | Leverage results from predicate/reference devices (K120601, K240661). Conforms to ISO 11137-1/2/3 and ISO 11607-1/2. |
| Viral Inactivation | Leverage results from reference devices (K242510, K240661). Conforms to ISO 22442-1/2/3. |
| Handling and Performance (Bio-Oss Pen) | Qualitative and quantitative handling and performance studies (and usability study) undertaken to support design modifications to the syringe. (Details are not in the provided text, but mentioned as having been done.) |
| Clinical Performance (General) | Leverage results from predicate/reference devices (K120601, K240661, K122894, K970321) for bench and non-clinical/clinical performance. No new clinical trials were explicitly required or presented in this summary for the "substantial equivalence" claim. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the typical AI/ML context. For a physical device like a bone graft, "test set" would typically refer to batches subjected to quality control, biocompatibility testing, or perhaps animal studies for efficacy. The document references leveraging prior studies for performance data.
- Data Provenance: The document does not specify the country of origin for the leveraged study data or whether it was retrospective or prospective, as this level of detail is not required for a 510(k) summary focused on substantial equivalence of a material.
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. This pertains to establishing ground truth for diagnostic image interpretation, which is not relevant for a bone grafting material. Ground truth for a bone graft is established through material characterization, biocompatibility testing (e.g., cytotoxicity, sensitization, implantation tests analyzed by pathologists), and gross/histological evaluation in animal models. These "experts" would be materials scientists, toxicologists, and veterinary pathologists, but their number and specific qualifications are not detailed in this 510(k) summary because new studies of this nature were not performed for this submission; prior data was leveraged.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This refers to consensus methods for establishing ground truth in diagnostic studies (e.g., by radiologists). This is irrelevant for a bone grafting material.
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 is specific to AI-enabled diagnostic devices assessing human reader performance. This device is a physical bone graft.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is specific to the performance of an AI algorithm in isolation. This device does not have an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device, "ground truth" for performance relates to:
- Material Characterization: Physical and chemical properties confirmed through lab assays (e.g., composition, particle size, porosity).
- Biocompatibility: Established through standardized in vitro and in vivo tests (e.g., cytotoxicity, irritation, sensitization, genotoxicity, implantation tests), with histological and pathological evaluations of tissues for reaction.
- Sterility: Confirmed through microbiological testing.
- Viral Safety: Demonstrated through validated viral inactivation processes.
- Bench and Non-clinical/Clinical Performance: Based on previous studies (potentially animal models or human clinical data from the predicate) demonstrating the material's ability to integrate with bone, support bone formation, etc. The document generally mentions "bench and non-clinical/clinical performance" data leveraged from predicates.
8. The sample size for the training set
- Not Applicable. This refers to AI model training data. This device does not use an AI model.
9. How the ground truth for the training set was established
- Not Applicable. This refers to how data used to train an AI model was labeled or validated. This device does not use an AI model.
In summary, the provided FDA 510(k) letter is for a traditional physical medical device. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for such devices revolve around demonstrating that the new device (or changes to an existing one) meets established safety and performance benchmarks relevant to its physical and biological function, primarily by showing substantial equivalence to existing, cleared devices. This is a fundamentally different assessment from that of an AI/ML diagnostic tool, which would necessitate the detailed information requested in the prompt.
§ 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.