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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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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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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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S1 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, apicocectomy, and cystectomy
• · Filling of extraction sockets to enhance preservation of the alveolar ridge
• · Elevation of the maxillary sinus floor
  · Filling of periodontal defects in conjuncts 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).

S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.
S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area.
S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite.
The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.

The provided text describes a 510(k) submission for a bone grafting material called "S1," manufactured by MedPark Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not contain any information about an AI/ML-based medical device or a study proving its performance against specific acceptance criteria for such a device. The device "S1" is a physical bone grafting material, and the tests described are non-clinical (physical, chemical, biocompatibility, sterilization, packaging, and animal studies) typically performed for such medical implants.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are relevant to AI/ML device evaluations, not to the physical bone grafting material described in this document.

The document focuses on comparing the physical, chemical, and biological properties of S1 to predicate bone grafting materials (Geistlich Bio-Oss® and MBCP Gel™) to demonstrate substantial equivalence for regulatory clearance.

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InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for:

Filling of extraction sockets to enhance preservation of the alveolar ridge

Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps InterOss® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation.

The product is available in the following shapes and sizes:

| Type | Weight
(mg) | Dimension
(mm) | Ref# |
|-------|----------------|-------------------|----------|
| Block | 50 | 6 x 6 x 3 | IOC-50 |
| Block | 100 | 6 x 6 x 6 | IOC-100 |
| Block | 250 | 7 x 9 x 8 | IOC-250 |
| Block | 350 | 8 x 10 x 9 | IOC-350 |
| Block | 500 | 10 x 12 x 10 | IOC-500 |
| Plug | 150 | 6 x 10 | IOC-P150 |
| Plug | 250 | 8 x 10 | IOC-P250 |
| Plug | 400 | 11 x 9 | IOC-P400 |
| Plug | 450 | 10 x 12 | IOC-P450 |

The provided document is a 510(k) premarket notification for the InterOss® Collagen bone grafting material. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning device. The "acceptance criteria" and "device performance" in the tables are for the physical and chemical properties and biocompatibility of the bone grafting material itself, not for an AI-powered system evaluating its efficacy or providing diagnostic information.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone performance (algorithm only).
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a traditional medical device (bone grafting material), not an AI/ML medical device, and thus the requested AI-specific information is not present.

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Wishbone HA is intended for the following uses:

· Filling of infrabony periodontal defects;

· Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration:

· Filling of defects after root resection, apicectomy and cystectomy;

• · Filling of extraction sockets to enhance preservation of the alveolar ridge;
• · Augmentation or reconstructive treatment of the alveolar ridge;
• · Elevation of the maxillary sinus floor;

· Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.

Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.

Wishbone HA is supplied as a mix of cancellous and cortical particles size 0.25 to 1.0 mm) in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.

The device is intended to be used in medical procedures, by a qualified physician (academically trained dentists, periodontists and oral surgeons).

This document is an FDA 510(k) summary for the medical device "Wishbone HA," a bone grafting material. It details the device's characteristics, intended use, and a comparison to a predicate device (Geistlich Bio-Oss), along with performance data to support its substantial equivalence.

Based on the provided text, the document describes performance testing for substantial equivalence of a bone grafting material (Wishbone HA) to a predicate device (Geistlich Bio-Oss). This is not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) study, so many of the requested criteria regarding AI model performance, ground truth, and human reader studies are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its equivalence.

Here's a breakdown of the information as it relates to the provided document:

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

The document does not explicitly present a table of acceptance criteria with reported performance in a quantitative manner for specific benchmarks. Instead, it describes various tests performed to demonstrate "substantial equivalence" to a predicate device. The general "acceptance criteria" here appear to be demonstrating equivalence across several key characteristics and performance aspects.

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

• Non-Clinical Bench Testing: The document states "Wishbone HA was the subject of the full range of physical and chemical bench testing characterization tests." It does not specify sample sizes for each test but implies adequate testing for characterization.
• Non-Clinical Animal Performance Testing: "A pre-clinical GLP study was performed in canine mandibular defect model system in Beagle dogs." The exact number of dogs is not specified, but "Beagle dogs" implies a cohort. This is prospective animal data.
• Biocompatibility Testing: "Wishbone HA was the subject of a range of biocompatibility tests in accordance with ISO 10993 series." No specific sample sizes given, but implies standardized testing.
• Viral Inactivation Studies: "The results of the viral inactivation studies showed that the raw material and device manufacturing processes...". No specific sample size is given.
• Sterilization, Packaging, Shelf Life Studies: Validation studies were performed according to specified standards. No explicit sample sizes are provided, but these studies typically involve specific sample numbers defined by the standards.

Data Provenance: The studies were performed to support an FDA 510(k) submission, suggesting they were conducted in a controlled environment (e.g., GLP for animal studies) by the manufacturer or their designated testing facilities. The canine study is "pre-clinical GLP," indicating a controlled, prospective animal study.

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

This section is not applicable as the document describes the substantial equivalence of a physical medical device (bone graft material), not an AI/SaMD product requiring expert ground truth for classification/detection tasks. The "ground truth" here is the physical and chemical properties and biological performance of the device itself and its comparison to a legally marketed predicate. The experts involved would be laboratory scientists, veterinarians (for animal studies), and potentially pathologists for tissue analysis.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among human readers, typically for image interpretation in AI/SaMD studies. This document concerns a physical device and its material properties/biological performance, which are evaluated through scientific measurements and observations, not reader consensus.

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 section is not applicable. This is not an AI/SaMD product, so no MRMC studies involving human readers and AI assistance were performed or are relevant.

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

This section is not applicable. This is not an algorithm or AI product.

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

The "ground truth" for this medical device is established through:

• Physical and Chemical Bench Testing: Direct measurement of material properties (e.g., chemical composition via analytical techniques, porosity, pH).
• Biocompatibility Testing: In vitro and in vivo tests against established ISO standards.
• Animal Performance Testing (Histopathology/Clinical Observations): Evaluation of tissue response, bone regeneration, and local effects in a canine model, likely through histological analysis and other veterinary assessments, compared to the predicate device.
• Sterilization & Packaging Validation: Conformance to recognized international standards (e.g., ISO, ASTM).

Essentially, the ground truth is based on scientific measurements, established international standards, and animal model outcomes.

8. The sample size for the training set

This section is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

This section is not applicable. As there is no training set for an AI model, there is no ground truth for it. The "ground truth" for the device itself is established through the robust testing methodologies described above.

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Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.

Porcine Mineral Collagen Composite is indicated for:

• Augmentation or reconstructive treatment of 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 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).

Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.

The product is available in the following shape and sizes:

This document describes the performance data for a medical device called "Porcine Mineral Collagen Composite" in the context of its 510(k) premarket notification to the FDA. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence through various performance tests rather than against explicit numerical "acceptance criteria" in the way one might see for an AI algorithm's sensitivity/specificity. However, the outcomes of these tests effectively serve as the criteria for acceptance to demonstrate equivalence to the predicate device.

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

• Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of guinea pigs for sensitization, number of mice for acute systemic toxicity) are not explicitly stated in the summary. The tests were performed in vitro (e.g., L929 MEM Elution) and in vivo (e.g., Guinea Pig Maximization, Rabbit Intracutaneous Reactivity, mice for systemic toxicity, canine for implantation).
• Bench Testing: Sample sizes for each bench test are not specified. These tests are inherently in vitro.
• Animal Testing (Canine Study): The sample size (number of canines) for the intrabony defect model is not specified. The study was in vivo, involving implantation at 4, 8, and 13 weeks. Its provenance is not stated (e.g., specific country or institution), but it's an animal study conducted to demonstrate performance.
• Data Provenance: The document does not explicitly state the country of origin for the data for any of the studies, nor does it explicitly classify them as "retrospective" or "prospective" as one would for human clinical trials. However, given the nature of the studies (biocompatibility, bench, animal), they would generally be considered prospective studies designed to evaluate the device.

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

This level of detail is not provided for most tests.

• Animal Testing (Canine Study): Radiographic, Micro CT, Histology, and Histomorphometry analyses were conducted. While these analyses require expert interpretation (e.g., veterinary pathologists, radiologists), the number of experts and their specific qualifications are not specified in this summary. The "ground truth" here is derived from the scientific measurements and observations from these analyses compared to a predicate device and sham control.
• For in vitro and other standardized tests (e.g., cytotoxicity, pyrogenicity), the "ground truth" is typically the result of the standardized test itself, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable or specified for the types of tests conducted. These are not studies requiring human expert adjudication of ambiguous cases, as would be common for AI in medical imaging. The studies focus on objective measurements and established biological responses.

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. This type of study (MRMC for AI assistance) was not performed because:

• The device is a medical implant (bone graft material), not a software or AI-driven diagnostic tool.
• "Clinical performance data was not required to determine substantial equivalence" (Page 8), meaning human clinical trials comparing device performance or AI assistance were not deemed necessary for this 510(k) submission.

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

No. This question is also specifically relevant for AI algorithms. The "Porcine Mineral Collagen Composite" is a physical device, so the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluation of this device is established through a combination of:

• Standardized Test Results/Reference Values: For biocompatibility tests (e.g., non-cytotoxic, non-mutagenic), specific thresholds or qualitative outcomes defined by recognized standards (ISO, USP) serve as the ground truth.
• Predicate Device Equivalence: For many bench tests (e.g., mineral content, calcium to phosphate ratio, porosity, pH), the "ground truth" is similarity to the legally marketed predicate devices, as the goal is to demonstrate substantial equivalence.
• Pathological/Histological Findings: In the canine intrabony defect model, ground truth is derived from objective measurements (e.g., radiographic density, Micro CT analyses) and expert evaluation of tissue samples (histology, histomorphometry) for parameters like tissue reaction, new bone formation, etc.

8. The Sample Size for the Training Set:

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable.

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

As there is no training set for an AI model, this question is not applicable. The device's characteristics are inherent to its manufacturing process and tested through established laboratory and animal study protocols.

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