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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.

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.

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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®

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. |

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