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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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EQUIMATRIX™ 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, 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).
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

EquiMatrix™ is a sterile, natural, non-antigenic, porous bone mineral matrix produced by the removal of organic compounds from equine bone. Due to its natural structure EquiMatrix™ is physically and chemically comparable to the mineralized matrix of human bone. The anorganic bone matrix of EquiMatrix™ has a macro and microporous structure similar to human bone. The formation and in-growth of new bone at the implantation site of EquiMatrix™ is favored due to its trabecular architecture, interconnecting macro and micro pores, and its natural consistency. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by v-irradiation.

The provided document is a 510(k) summary for the EquiMatrix™ Natural Bone Mineral Matrix. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, Bio-Oss®.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:

The document does not describe an AI/ML device. It is a regulatory submission for a medical device (bone grafting material) that is a physical product, not a software algorithm. Therefore, many of your specific questions related to AI/ML device performance (like sample sizes for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training sets) are not applicable to this document.

However, I can extract information related to the device's "performance" and "acceptance criteria" as understood in the context of this biological material.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically demonstrating equivalence to a recognized standard or predicate device in terms of material properties, biocompatibility, and intended biological function (e.g., bone formation). The document argues for substantial equivalence to Bio-Oss®.

Since this is a non-AI/ML device, the following points are not applicable or cannot be extracted from the document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as this is not an AI/ML device. The document mentions "several animal studies" and a "clinical case series" but does not provide sample sizes or data provenance details for these studies.

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 as this is not an AI/ML device. Ground truth, in a clinical sense for this device, would be histological analysis of bone growth, clinical outcomes (implant placement success), and assessment of defect healing, typically done by attending clinicians or pathologists, but not "experts establishing ground truth for a test set" in the AI/ML context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/ML device.

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 as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the biological performance of the device (bone formation), the document implies:
  • Histological assessment: Implied by "formation and in-growth of new bone," likely from the animal studies.
  • Clinical outcomes data: Mention of "defect healing and formation of new bone of sufficient quality to obtain dental implant placement" from the "clinical case series" suggests clinical assessment of surgical sites and successful subsequent treatment.
  • Physico-chemical characterization: Ground truth for material properties (composition, morphology) is established through analytical techniques like XRD, FT-IR, ICP analysis.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable as this is not an AI/ML device.

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