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FG Bone Graft B is 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).

FG Bone Graft B is a sterile, synthetic, multi-porous biocompatible ceramic matrix in granular form for filling bone defects. The material with microporous structure supports rapid ossification with local bone. With its phase purity of >= 99%, the ceramic material complies with US standard specification ASTM F 1088-04. The validated manufacturing process guarantees batch conformity and reproducibility.

The FDA 510(k) clearance letter for FG Bone Graft B indicates that the device is substantially equivalent to a predicate device (CERASORB M DENTAL). The clearance letter references non-clinical tests performed to demonstrate this equivalence, focusing on chemical composition, physical properties, and performance in vivo.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample size for the test set: The document states that the in vivo study used a "Beagle dog" model, and the animals were "divided into groups: test group (FG Bone Graft B), positive control group (Cerasorb, a commercial β-TCP), and a negative control (empty defect)." However, the exact number of animals in each group or total animal count is not specified in the provided text.
• Data provenance: The study was a prospective in vivo animal study performed on Beagle dogs. The location/country of origin of the study is not explicitly stated in the provided text, but the submitter "Full Golden Biotech Co., Ltd." is located in Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of experts: Not explicitly stated. The histological and radiographic analyses were likely performed by trained professionals (e.g., veterinary pathologists, radiologists), but the number of reviewers or their specific qualifications are not detailed in the provided text.
• Qualifications of experts: Not specified beyond the implied expertise in conducting and analyzing in vivo studies (e.g., histology, micro-CT).

4. Adjudication Method for the Test Set

• Adjudication method: Not explicitly stated. For animal studies, consistency and blinding are typically employed, but a formal "adjudication method" in the sense of multiple human readers for consensus is not described for this non-AI bone graft device. The results are presented as quantitative measurements and observations (e.g., "new bone formation increased," "minimal to mild inflammatory response").

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/image analysis devices where the AI's impact on human reader performance is being assessed. This document describes a traditional preclinical performance study for a bone graft material.

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

• Standalone performance: N/A. This is a bone graft material, not an algorithm or AI device. The "performance" refers to the biological and physical properties of the material itself, not the output of a software algorithm.

7. The Type of Ground Truth Used

• Type of ground truth: The ground truth for the in vivo study (which is the primary performance study) was established through direct anatomical, histological, and radiographic assessments of the bone defects in the animal model.
  • Histological analysis: Quantified new bone formation, material degradation, and inflammatory response. This involves microscopic examination of stained tissue sections, which is considered a gold standard for assessing tissue regeneration and integration.
  • Radiographic analysis: Used micro-CT to assess bone density and bone volume, providing quantitative structural data.
  • Comparison to predicate: The "ground truth" for showing substantial equivalence was the performance of the established predicate device (Cerasorb) under the same study conditions.

8. The Sample Size for the Training Set

• Sample size for training set: N/A. This device is a bone graft material, not an AI or machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Ground truth for training set: N/A. As there is no AI component, there is no training set and no ground truth establishment for such a set.

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Geistlich Bio-Gide® is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects; and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Shape is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth; and
• guided bone regeneration in dehiscence defects.

Geistlich Bio-Gide® Compressed is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Forte is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Perio is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

• augmentation or reconstructive treatment of the alveolar ridge;
• filling of 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-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 30 x 40 mm, 40 x 50 mm.

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

Geistlich Bio-Gide® Forte is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 mm.

Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

The provided FDA 510(k) clearance letter and associated S510(k) summary documents describe a class II medical device, Geistlich Bio-Gide and its variants, which are resorbable bilayer membranes and bone grafting materials. This submission is for a determination of substantially equivalent to a predicate device.

Crucially, this document is focused on demonstrating substantial equivalence based on material characteristics, manufacturing processes, and performance data for the device itself (a physical membrane and bone grafting material), not on the performance of an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and effect sizes for AI assistance are not applicable to this type of medical device submission. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted to confirm the physical and biochemical properties of the new device are equivalent to the predicate device, especially after changes to supplier and manufacturing processes.

Here's an attempt to extract relevant information and note the inapplicable sections based on your request:

Acceptance Criteria and Device Performance (for a physical medical device)

1. A table of acceptance criteria and the reported device performance

Since this is not an AI/ML device, the acceptance criteria are not typically expressed in terms of accuracy, sensitivity, or specificity. Instead, they are based on physical, chemical, and biological properties demonstrating equivalence to a predicate device. The performance data provided is primarily comparative to the predicate.

The "analysis" column in the provided tables consistently states "The material of construction is identical," "The sizes offered are identical/similar," etc., implying the acceptance criterion is indeed identity or substantial similarity to the predicate.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of an AI/ML model. The performance data consists of various physical, biochemical, and experimental tests. The number of samples for each specific test (e.g., number of membranes for tensile strength testing) is not provided.
• Data Provenance: Not specified regarding country of origin. The studies are described as "in vitro and in vivo biocompatibility," "sterilization," "shelf-life," "bench," and "clinical performance studies" leveraged from previous predicate device submissions (e.g., K212463, K171643). These are likely a mix of lab-based and potentially historical clinical data. It is not specified if these are prospective or retrospective studies; however, given they are leveraged from previous clearances, they would be historical for this specific submission.

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 is not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in that manner. The "ground truth" for a resorbable membrane involves objective physical, chemical, and biological measurements, and comparison to established standards and predicate device characteristics, not expert consensus on image interpretation.

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

• Not Applicable. No human adjudication method is described or relevant for the physical and chemical performance tests conducted on this medical 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. This is not an AI-assisted device, so MRMC studies are not relevant.

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

• Not Applicable. This is not an AI algorithm. Its "standalone" performance refers to its intrinsic physical and chemical properties.

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

• Not Applicable / Different Context. The "ground truth" for this device's performance is established by:
  • Objective Measurements: Results of standardized physical and biochemical tests (e.g., SEM, porosity, tensile strength, DSC, solubility, degradation, molecular weight, hydration capacity, suture pull-out force).
  • Regulatory Standards: Compliance with ISO and ASTM standards (e.g., ISO 10993-1, ISO 11137 series, ISO 22442-3, ASTM F2450-18, ASTM F2150-19, ASTM F2212-20).
  • Predicate Device Data: Comparison and leveraging of performance data (biocompatibility, sterilization, shelf-life, bench, clinical) from previously cleared predicate devices. The claim is substantial equivalence, meaning it performs as safely and effectively as the legally marketed predicate.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary of the Study Proving Device Meets Acceptance Criteria (in this context):

The "study" conducted for the Geistlich Bio-Gide product family in this 510(k) submission primarily consists of a comprehensive battery of non-clinical performance tests combined with the leveraging of existing performance data from previously cleared predicate devices. The purpose of these tests was to demonstrate that modifications (e.g., new slaughterhouse, non-significant manufacturing changes) did not alter the fundamental safety and effectiveness of the device, making it substantially equivalent to its predicates.

The non-clinical tests included:

• Physical and Biochemical Testing: SEM (surface morphology), porosity, tensile strength, DSC (onset temperature), suture pull-out force, solubility, enzymatic degradation, SDS-PAGE (molecular weight distribution), and hydration capacity. For Geistlich Bio-Gide Forte and Compressed, handling properties were also evaluated.
• Other Experimental Testing: Viral safety according to ISO 22442-3:2007.

These tests, performed on the modified devices, aimed to show that their properties were consistent with a product that would continue to perform as intended and as safely and effectively as the predicate devices. The acceptance criteria were implicitly that the new devices exhibit equivalent performance characteristics to the cleared predicate devices, as supported by these various in vitro and experimental studies and referencing past clinical data from the predicates.

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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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SwissGraft X 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)
• filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

SwissGraft X is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral granules. SwissGraft X serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous, hydrophilic, and has a large inner surface area. SwissGraft X is sterilized by x-ray irradiation. SwissGraft X is provided in granule form.

The provided document is an FDA 510(k) clearance letter for a bone grafting material called "SwissGraft X." It does not describe an AI medical device or present a study comparing the device's performance against acceptance criteria in the manner typically expected for AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document describes a traditional medical device (bone grafting material) seeking clearance based on substantial equivalence to a predicate device. The performance data section refers to standard biocompatibility, sterilization, shelf-life, and packaging validation, along with characterization of structural, mechanical properties, and granule size distribution – all common for a physical medical product.

Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for training/test sets) are not applicable to the information contained in this specific FDA clearance letter for SwissGraft X.

Here's an analysis based on the available information, with notes where information is not present or not applicable to an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

As "SwissGraft X" is a bone grafting material and not an AI or diagnostic device, the acceptance criteria relate to its physical and biological properties rather than diagnostic performance metrics (like sensitivity, specificity, AUC). The document refers to "testing against final product specifications" and "characterization of structural and mechanical properties" for the new product line's smaller granule sizes and different filling weights compared to the predicate device. Specific numerical acceptance criteria or performance values are not detailed in this summary, but the conclusion states that these evaluations support substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary as it typically would be for a clinical validation or AI performance study. The "Performance Data" section states that results from the applicant's own predicate device (K240661) were "leveraged" for biocompatibility, sterilization, shelf-life, and packaging validation. For the specific differences (granule size and filling weights), "testing against final product specifications" and "characterization of structural and mechanical properties" were undertaken. The exact sample sizes for these bench tests are not disclosed.

Data Provenance: The manufacturer is "Geistlich Pharma AG" based in Wolhusen, Switzerland. The predicate device's data was used, but details on the provenance of those original studies are not given here. The studies mentioned are primarily bench/laboratory based for material characterization, not typically clinical or retrospective/prospective data sets in the AI sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not applicable here. The device is a physical bone grafting material, not a diagnostic AI that requires expert-established ground truth for performance evaluation. Its performance is assessed through laboratory tests (e.g., material characterization, sterilization validation) against technical specifications, not against expert clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of expert adjudication for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a clearance for a bone grafting material, not an AI device, so MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. "SwissGraft X" is not an algorithm or software. It is a physical bone grafting material.

7. The Type of Ground Truth Used

For a physical device like SwissGraft X, "ground truth" refers to established scientific/engineering principles, material standards, and validated test methods (e.g., for biocompatibility, sterility, material properties) rather than clinical ground truth (like pathology or expert consensus). The product is evaluated against its own "final product specifications" and characterization results are compared against those of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. The device is a physical product, not an AI model that requires a ground truth for a training set.

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SwissMembrane X is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects; and
• guided tissue regeneration procedures in periodontal defects.

SwissMembrane X Socket is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects.

SwissMembrane X and SwissMembrane X Socket are resorbable collagen membranes made of porcine collagen. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membranes are made of collagen without further cross-linking and are sterilized by gamma irradiation.

SwissMembrane X is provided in the following variants and sizes:

• SwissMembrane X D-Line
  • 13 x 25 mm (rectangle)
  • 25 x 15/25 mm (trapezoid)
  • 30 x 25/40 mm (trapezoid)
• SwissMembrane X Socket D-Line
  • 14 x 24 mm

The provided FDA 510(k) Clearance Letter for SwissMembrane X and SwissMembrane X Socket indicates that the device has been cleared based on substantial equivalence to a predicate device, Geistlich Bio-Gide® and Geistlich Bio-Gide® Shape (K212463).

This type of clearance (510(k)) generally means that the device does not require new detailed performance data to prove safety and effectiveness if it can demonstrate through comparison that it is as safe and effective as a legally marketed predicate device. Therefore, the document does not describe acceptance criteria for performance, nor does it detail a study proving device performance against specific metrics in the way one might expect for a novel device or a device involving an AI component.

The document explicitly states:

"Non-clinical data was not deemed necessary to support the extension to the product line. As the subject devices fall within the range of size configurations cleared under the predicate device, there is no new worst-case configuration."

"Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K212463) were leveraged in support of substantial equivalence."

Because the clearance is based on substantial equivalence to an existing and already cleared device, the typical requirements for a new performance study with specific acceptance criteria, test sets, and ground truth establishment (as is common for AI/ML-driven devices or novel diagnostic tools) are not present or reported in this 510(k) summary.

Therefore, the following information cannot be extracted from this document as no new performance study, in the sense of demonstrating a device's de novo performance against predefined metrics, was conducted or reported for this submission.

Based on the provided document, the following information cannot be extracted for the reasons stated above:

1. A table of acceptance criteria and the reported device performance: Not applicable. Performance data against specific acceptance criteria for a new study is not provided, as substantial equivalence was based on the predicate device's data.

2. Sample sized used for the test set and the data provenance: Not applicable. No new test set for proving performance was described. The submission leveraged existing data from the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment process for a performance study is described.

4. Adjudication method for the test set: Not applicable. No new test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. No MRMC study described. The device is a physical bone grafting material/membrane, not one that typically involves human readers assisted by AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.

7. The type of ground truth used: Not applicable. No new performance study requiring independent ground truth is described.

8. The sample size for the training set: Not applicable. This is not an AI/ML device; therefore, no training set is relevant.

9. How the ground truth for the training set was established: Not applicable. No training set is relevant.

Summary of what the document DOES state regarding "performance data":

The "Performance Data" section (Page 7) explicitly states that "Non-clinical data was not deemed necessary to support the extension to the product line." It further clarifies that "Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K212463) were leveraged in support of substantial equivalence."

This means the acceptance criteria and performance data for this particular 510(k) submission refer back to the studies and their results that supported the initial clearance of the predicate device (K212463). The current submission argues that since SwissMembrane X and SwissMembrane X Socket are essentially variants (different shapes and sizes within an existing range) of the already cleared predicate device, no new performance studies are required. They are considered "substantially equivalent" based on identical materials, manufacturing, sterilization, and similar use cases, and the safety and efficacy of the underlying technology have already been established by the predicate device's clearance.

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Geistlich Bio-Flow® is intended for bone regeneration of contained defects around teeth or dental implants for the following uses:

1. filling of extraction sockets to enhance preservation of the alveolar ridge in contained situations with entirely intact, circumferential bone walls.

2. filling of contained periodontal defects of limited size with intact lingual and buccal walls, i.e. 3-wall intrabony defects.

3. filling of contained peri-implant defects of limited size to include 3-wall defects of a size up to 4 mm x 5 mm x 4 mm.

Geistlich Bio-Flow® is a flowable, sterile, biocompatible bone mineral plus collagen matrix consisting of Geistlich Bio-Oss® granules (K122894) and processed Geistlich Bio-Gide® collagen (K212463) in an 80:20 (dry weight) ratio. Geistlich Bio-Flow® is provided as dry granulated material pre-filled in a mixing syringe (0.2 cc or 0.5 cc fill volumes). Cannulas and a syringe for applying saline or blood to hydrate the product prior to extrusion are included with the product.

The provided text is a 510(k) Summary for a medical device (Geistlich Bio-Flow®), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics for a diagnostic or AI-based device. This document describes the device, its intended use, and non-clinical performance data to support its safety and effectiveness. It does not contain an "acceptance criteria" table with specific thresholds or a detailed study of an AI device's performance against ground truth as would be found in a typical AI/diagnostic device submission.

However, I can extract the relevant information from the document that best approximates the requested points based on the nature of this submission. Since this is a bone grafting material, the "performance" is assessed through non-clinical (material characterization and animal) studies rather than a multi-reader, multi-case study, or standalone AI performance.

Here's an interpretation based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state quantitative acceptance criteria or a performance table in the format typically used for AI/diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, "performance" is demonstrated through various non-clinical tests and a non-clinical animal study, with the overarching "acceptance criterion" being comparable performance to the predicate device in relevant biological and material characteristics.

2. Sample size used for the test set and the data provenance

• Test Set (Animal Study): The document states "a non-clinical performance study was conducted to support the indications for use for the device," and "In a study assessing new bone growth and device resorption (4, 8, and 12 weeks), at both 8 and 12 weeks, the bone substitute performance of the test and control groups was comparable."
  • Sample Size: The document does not specify the exact number of animals or defects studied.
  • Data Provenance: Non-clinical (animal study). No country of origin is specified. It is a prospective study as it involved conducting tests with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable to this type of submission. The performance study was an animal model, not a human reader study requiring expert interpretation to establish ground truth for a diagnostic output.

4. Adjudication method for the test set

• This is not applicable as it was not a human reader study. The animal study results would likely be evaluated by veterinary histopathologists or researchers in a blinded manner, but no specific adjudication method (like 2+1) is mentioned.

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

• No, an MRMC comparative effectiveness study was not done. This device is a bone grafting material, not a diagnostic or AI-assisted device.

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

• No, a standalone performance study in the context of an algorithm or AI was not done.

7. The type of ground truth used

• For the non-clinical performance study (animal study), the "ground truth" would be established by histological analysis (e.g., measurements of new bone formation, defect fill, and resorption characteristics) and potentially other quantitative analyses in the animal model. This falls under outcomes data simulation in an animal model.

8. The sample size for the training set

• This concept (training set) is not applicable to the evaluation of this bone grafting material. There is no AI model being trained.

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

• This concept is not applicable as there is no AI model or training set.

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Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)

Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.

The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.

It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.

The provided document is a 510(k) summary for a medical device called "Synthetic Bone Graft Particulate." It focuses on demonstrating substantial equivalence to a predicate device ("PerioGlas - Bioglass Bone Graft Particulate") for regulatory clearance.

This document does not contain acceptance criteria or study details for an AI/ML-driven device's performance. The "performance data" section (Section 7) describes non-clinical tests (sterilization, shelf-life, biocompatibility, chemical/physical properties) and an animal study for the bone graft material itself, not for an AI/ML system.

Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device. The device described in the document is a physical medical implant (synthetic bone graft particulate), not an AI/ML software or system.

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Xenograft Bovine Bone Particulate is intended for use in dental surgery.

The products may be used in surgical procedures such as:

• Augmentation or reconstructive treatment of alveolar ridge
• Filling of periodontal defects
• Filling of defects after root resection, apicocectomy, and cystectomy
• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of maxillary sinus floor
• Filling of defects in conjunction with products intended for Guided Bone Regeneration (GBR)
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

The Xenograft Bovine Bone Particulate is a porous bone mineral matrix that is used in periodontal, oral, and maxillofacial surgery. It has a trabecular architecture, interconnecting macro and micro pores and consistency which allows formation and ingrowth of new bone. The particulate is available in clinically relevant sizes. The anorganic bone composition meets all requirements found in ASTM 1581-08: Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is packaged, and electron beam irradiated to meet all requirements and is non-pyrogenic. Using standard dental techniques, the dentist will loosely pack the xenograft particulate granules into the osseous defect using sterile instruments.

This document is a 510(k) premarket notification for a medical device, the "Xenograft Bovine Bone Particulate." It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove acceptance criteria for a new, novel device. Therefore, much of the requested information (like sample sizes for test/training sets, expert details for ground truth, MRMC studies, standalone performance, etc.) is not directly applicable or available in this type of submission.

However, I can extract the acceptance criteria related to the device's characteristics and the non-clinical performance testing conducted to demonstrate that the device meets its requirements and specifications, thereby supporting its substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail table for novel device performance metrics. Instead, it demonstrates that the subject device's characteristics and performance are "substantially equivalent" to a predicate device and meet recognized industry standards. The "performance" here refers to demonstrating these equivalences and adherence to standards.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document mentions an "in-vivo performance" study conducted in a "beagle mandibular intraoral critical size defect model." However, the specific number of beagles or defects used in this model is not specified in the provided text.
• Data Provenance: The in-vivo study appears to be an experimental animal study (beagle model) conducted for the purpose of this submission. The country of origin is not stated but typically these studies are conducted in a controlled lab environment. It is a prospective study for the purpose of demonstrating equivalence, as it was designed and executed to compare the subject device against the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The ground truth for the in-vivo study was assessed by histomorphometry and histopathology. The document does not specify the number of experts (e.g., pathologists, histomorphometrists) or their qualifications.

4. Adjudication method for the test set

• The document does not specify an adjudication method for the histomorphometry and histopathology assessments. It's likely standard laboratory practice was followed, but no details are given.

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

• This device is a physical medical device (bone graft particulate), not an AI or imaging diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• This question is not applicable as the device is not an algorithm or software.

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

• For the in-vivo performance study, the ground truth was established through histomorphometry and histopathology assessments of new bone formation, residual graft material, and tissue reaction in beagles. This is a form of pathology/histological assessment.

8. The sample size for the training set

• This question is not applicable as the device is not an AI/ML model that requires a training set. The "training" here would refer to the manufacturing and quality control processes to ensure the consistency of the particulate.

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

• This question is not applicable as the device is not an AI/ML model. The "ground truth" for manufacturing would be established through adherence to Good Manufacturing Practices (GMP) and compliance with specified material and sterility standards.

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THE Graft Collagen is recommended for:

• Filling of extraction sockets to enhance preservation of the alveolar ridge.

THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation.
THE Graft Collagen is available in various sizes.
Block (Height x Length x Width)
3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm
THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.

Description of the Device

The device, "THE Graft Collagen," is a bone grafting material composed of a porcine-derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. It is designed to be trimmed and molded to fit various defect shapes and comes in block form in different sizes (e.g., 3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5 x 10 mm, 7 x 7 x 7 mm). It contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen. The granules act as a scaffold for new bone, while the collagen helps hold the granules together and facilitates handling. The device is sterilized using gamma irradiation.

Indications for Use

THE Graft Collagen is recommended for:

• Filling of extraction sockets to enhance preservation of the alveolar ridge.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for "THE Graft Collagen" are based on demonstrating substantial equivalence to its predicate devices, K122894 Bio-Oss® Collagen (primary predicate) and K173188 The Graft Bone Substitute (reference predicate), through non-clinical performance testing. The reported device performance aligns with these criteria, confirming substantial equivalence.

Study Details

Due to the nature of this submission being a 510(k) premarket notification for a Class II medical device (Bone Grafting Material) that primarily relies on demonstrating substantial equivalence to predicate devices, the detailed information typically found in clinical trials for AI/software devices (e.g., explicit test set sample sizes, data provenance for clinical images, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or large-scale training set details) is not applicable or not provided in the document.

The "study" that proves the device meets acceptance criteria consists of:

1. Bench Testing: Performed on the device itself to evaluate physicochemical properties (Ca/P ratio, residue on ignition, heavy metal, pH, compressive strength).
2. Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including various in vitro and in vivo tests.
3. Sterilization Validation: Performed according to ISO 11137.
4. Shelf-Life Study: A real-time aging study in accordance with ISO 11607.
5. Control of Animal Origin Materials Validation: Performed according to ISO 22442-2 and ISO 22442-3.
6. Comparative In-Vivo Study: An animal study comparing the performance of the subject device to the primary predicate device in a beagle mandibular intraoral model.

Here's the breakdown of the specific points requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance: Provided above.

2. Sample sized used for the test set and the data provenance:

   • In-Vivo Study (Beagle Mandibular Intraoral Model): The specific number of animals (beagles) used in the study is not explicitly stated, nor is the country of origin of the study. It is an animal implant study used for performance comparison.
   • Bench, Biocompatibility, Sterilization, Shelf-Life, Animal Origin Control tests: Sample sizes for these tests are not provided in this summary but would be standard for material and safety testing of medical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and study. The ground truth in the animal study would be based on scientific and pathological assessments (histology, histomorphometry, Micro-CT) performed by qualified scientific personnel (e.g., veterinarians, pathologists, histotechnicians), but their specific number and qualifications are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of animal study and material testing conducted. Data analysis would involve measurements and interpretations by individual experts or teams, rather than a consensus-based adjudication process for diagnostic labeling.

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 a bone grafting material, not an AI/software device involving human readers or interpretation of diagnostic images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

   • In-Vivo Study: The "ground truth" was established through histology, histomorphometry, and Micro-CT analyses in a beagle mandibular intraoral model, assessing new bone formation, integration, and other tissue responses. This combines pathological assessment with quantitative imaging analysis.
   • Other tests: Ground truth for bench performance, biocompatibility, sterilization, and shelf-life is based on established scientific and regulatory standards (e.g., ISO, USP) and laboratory measurements.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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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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