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FG Bone Graft M is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Typical uses include:

• Periodontal/Intrabony defects filling
• Ridge augmentation
• Implant preparation, placement in extraction sites
• Sinus lifts
• Cystic cavities filling

The Synthetic Bone Substitute, FG Bone Graft M, is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (β-TCP).

The synthetic bone substitute is presented in a porous form required for the conduction of precursor cells to the defect site to facilitate new bone growth.

This product is provided sterile for single patient use.

The synthetic bone substitute is progressively replaced by new bone according to the remodeling process.

N/A

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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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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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CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include:

• Intrabony periodontal osseous defects
• Furcation defects
• Bony defects or bony deficiencies of the alveolar ridge
• Intraoral, maxillofacial, and mandibular augmentation
• Bony defects of the upper or lower jaw
• Filling of tooth extraction sites
• Sinus elevation grafting

CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.

This is a 510(k) premarket notification for a medical device called CMFlex™, a synthetic bone grafting material. The document focuses on demonstrating the substantial equivalence of CMFlex™ to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" in the sense of predefined thresholds for performance metrics that the device must meet. Instead, it compares the characteristics and performance of the CMFlex™ (subject device) to those of predicate devices to establish substantial equivalence. The "Conclusions" column in Table 1.3 effectively serves as the reported performance relative to the predicate devices for each performed test.

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

• Test Set for Animal Model:

  • The document states "Canine critical sized defect model" but does not specify the exact number of canines or defects used.
  • Data Provenance: Prospective (animal model). The country of origin is not specified, but typically such studies supporting U.S. FDA submissions are conducted under GLP (Good Laboratory Practice) regulations, often in the U.S. or facilities elsewhere compliant with those standards.

• Test Set for Benchtop/Material Characterization:

  • For tests like mechanical strength, pH, crystallinity, porosity, etc., standard ASTM or ISO methods were used, which imply specific sample sizes for replicate testing. However, the exact sample sizes (e.g., "n=5" for each test) are not explicitly stated in this summary.
  • Data Provenance: Not specified, but generally refers to laboratory testing of the manufactured device.

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

This information is not provided in the document. The animal study involves assessments (radiography, microCT, histomorphometric analysis), which would typically be performed and interpreted by qualified experts (e.g., veterinary radiologists, pathologists specialized in bone and biomaterials), but their number or specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document. For assessments in the animal study, it is common practice to have blinded assessments and potentially multiple reviewers, but the specific adjudication method is not 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:

Not applicable. This document describes a traditional 510(k) submission for a physical bone grafting material, not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

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

Not applicable. As stated above, this is not an AI/software device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the animal study:

• Pathology/Histomorphometry: "histomorphometric analysis" was explicitly conducted, which relies on expert pathological evaluation of tissue sections.
• Imaging: "radiography, microCT" implies radiological interpretation.
• Outcomes Data: "new bone growth, residual implant material, preservation of ridge (height, width, depth), changes to surrounding bone, and any significant adverse findings" refer to biological outcomes assessed in the animal model.

For benchtop tests, the "ground truth" is derived from the results of the specified standard test methods.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context. The manufacturing specifications and quality control procedures ensure consistent device characteristics, which are then verified through the performance data described.

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

Not applicable. As stated above, there is no training set for this type of device.

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InRoad® Dental Synthetic Bone Graft is intended for the filling and reconstruction of multi-walled bone defects such as:

• Defects after removal of bone cysts
• Augmentation of the atrophied alveolar ridge
• Sinus lift and sinus floor elevation (subantral augmenation)
• Filling of alveolar defects following tooth extraction for alveolar ridge preservation
• Filling of extraction defects to create an implant bed
• Filling of two- or multi- walled infra-bony pockets. and bi- and trifurcation defects
• Support function for a membrane in controlled tissue regeneration (CTR)
• Defects after surgical removal of retained teeth or corrective osteotomies
• Other multi-walled bone defects of the alveolar processes

InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense porous bioceramic for bone regeneration. It is comprised of 90 ± 5% hydroxyapatite (HA) and 10 ± 5% ß-Tricalcium Phosphate (B-TCP). The granules are provided sterile (gamma irradiated) in a capped vial packaged in a sealed tray with lid. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, a secondary channel-like structure, and tertiary small holes on the surface resulting in a biocompatible, osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental Synthetic Bone Graft is available in granule form in sizes of 0.3 - 1.0 mm (Small) and 0.8 - 1.8 mm (Large).

The provided text describes a 510(k) premarket notification for the "InRoad® Dental Synthetic Bone Graft" device (K202675). This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria in the context of device performance metrics often associated with AI/software devices.

Because this is a bone graft material, the "acceptance criteria" and "study" are related to its biological safety and performance in vivo against a predicate device, not statistical performance metrics of algorithms. Therefore, many of the requested fields (such as sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

Here's an interpretation based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/software device. Instead, acceptance for this medical device (a bone graft) is based on demonstrating biocompatibility and equivalent in-vivo performance to a legally marketed predicate device.

The reported performance criteria and findings are summarized as follows:

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

• Animal Testing: The "sample size" for the in-vivo performance study is "dogs" with a "one-wall periodontal defect model." The exact number of dogs is not specified in this summary.
• Data Provenance: The animal study was conducted with a "US marketed membrane" and compared against a "US marketed predicate device." This suggests the study was conducted within a context relevant to the US market, likely in the US, but the specific country of origin is not explicitly stated. The study is prospective in nature as it involves treatment and observation over time (4, 8, and 12 weeks).

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

• Not Applicable. For a bone graft material, "ground truth" is typically established through observable biological responses and measurements (e.g., histopathology, micro-CT analysis) by qualified personnel (veterinarians, histopathologists, statisticians). The document does not specify the number or qualifications of experts in this context, nor is it a requirement for this type of device submission to detail expert consensus on "ground truth" in the way it would be for an AI diagnostic device.

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

• Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for human interpretation tasks, especially in AI diagnostic studies. For an animal study evaluating bone growth and graft resorption, the assessments (e.g., radiographic, micro-CT, histopathological, histomorphometry) are objective measurements and interpretations performed by a team, rather than a consensus-based adjudication process for subjective human readings.

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 is a bone graft material, not an AI/software device. Therefore, no MRMC study involving human readers with or without AI assistance was performed.

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

• No. This is a physical medical device (bone graft), not an algorithm. Therefore, no standalone algorithm performance study was done.

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

• The "ground truth" for the animal study was established through a combination of objective and interpretative methods:
  • Animal health observation
  • Radiographic assessment
  • Micro-CT evaluation with statistical analysis
  • Histopathological evaluation
  • Histomorphometry

8. The sample size for the training set

• Not Applicable. This is a physical medical device (bone graft), not an AI/software 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, there is no ground truth for a training set to be established.

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OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.

OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and < 10% Hydroxyapatite (Ca10(PO4)6 (OH)2) resorbable micro-structured bone grafting material for the repair of bony defects. OsOpia induces and guides the three-dimensional regeneration of bone in the defect site into which it is implanted. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all planes (e.g. bioresorbable barrier membranes). When placed next to viable host bone, new bone will be deposited on the surface of the implant resorbs and is replaced by bone during the natural process of bone remodelling.

OsOpia is gamma sterilized, comes in several sizes in granular form, and is double sterile packaged for single use only.

The provided text describes the regulatory clearance for the OsOpia Synthetic Bone Void Filler. It does not, however, describe the acceptance criteria of a device (e.g., an AI/ML algorithm or diagnostic tool) in the typical sense of performance metrics like sensitivity, specificity, or F1-score. Instead, it details the criteria and studies used to demonstrate substantial equivalence for a medical device (a bone grafting material) to existing legally marketed predicate devices, as required for a 510(k) submission to the FDA.

Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in the context of this traditional medical device submission, which is not for an AI/ML device.

However, I can extract the relevant information from the provided document regarding how the device (OsOpia Synthetic Bone Void Filler) met the criteria for substantial equivalence.

Here's a breakdown based on the document:

1. Table of "Acceptance Criteria" (for Substantial Equivalence) and Reported Device Performance

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

• Clinical Studies (Test Set):
  • Sample Size: 90 patients overall, across six clinical studies.
  • Data Provenance: Not explicitly stated from which country/countries the patients originated, but the studies were prospective. One study was randomized, and the others were single-arm.

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. For this bone grafting material, the "ground truth" in clinical studies would typically be assessed by the treating surgeons, periodontists, or oral and maxillofacial surgeons, and confirmed through histological analysis (for bone formation) or clinical follow-up (for implant survival). The document does not specify the number or qualifications of experts for these assessments, but rather the results of those assessments.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for discordance resolution in image interpretation or diagnostic evaluations, which is not relevant for the assessment of 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 a medical device (bone grafting material), not an AI/ML diagnostic or image analysis tool. MRMC studies are not relevant here.

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

• Not Applicable. This is a bone grafting material, not an algorithm.

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

• Clinical Ground Truth:

  • Bone Histology: Used in two studies (at 5-6 months post-implantation) to assess new bone formation. This is a form of pathology/histological analysis.
  • Implant Survival: Used in four studies, representing outcomes data.
  • Adverse Events: Monitoring for adverse events is also a form of outcomes data/safety assessment.

• Pre-clinical/Bench Ground Truth:

  • Biocompatibility: Based on compliance with ISO standards.
  • Sterility: Based on compliance with ISO standards and SAL testing.
  • Material Properties: Based on analytical techniques like XRD, FTIR, ICP/MS, and mercury intrusion porosimetry, compared against known characteristics of similar materials (predicates).
  • Animal Model Performance: Assessment of bone regeneration in a sheep model.

8. The sample size for the training set

• Not Applicable. This is a traditional medical device, not an AI/ML algorithm that requires a training set. The "data" here supports substantial equivalence rather than training a model.

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

• Not Applicable. See point 8.

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Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:

• Intrabony periodontal osseous and furcation defects
• Augmentation of bony defects of the alveolar ridge ●
• Filling tooth extraction sites ●
• Sinus elevation grafting .

Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling.
BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.

This document is an FDA 510(k) summary for the Straumann® BoneCeramic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, many of the requested elements are not applicable in the context of this 510(k) summary.

However, based on the provided text, here’s an analysis:

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

The document does not present specific acceptance criteria in a quantitative table format with corresponding device performance metrics for a clinical study. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (K040646 Straumann Granules) by showing similar technological characteristics and relying on the predicate's established safety and effectiveness.

The "reported device performance" is primarily qualitative and inferred from the long-term use of the predicate device and the new device sharing similar characteristics.

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

This information is not provided. The document refers to "review of the relevant clinical literature included 18 clinical publications," but does not detail the sample sizes, study designs (retrospective/prospective), or data provenance of these publications. For the internal device performance checks (biocompatibility, packaging, sterilization, pyrogenicity), the "sample size" would refer to the number of units tested, but this detail is not given.

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. The document does not describe a test set with a ground truth established by experts in the context of an AI/image analysis device. The "ground truth" for the device's performance is inferred from compliance with standards and clinical literature demonstrating real-world efficacy.

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

Not applicable. There is no mention of an adjudication method as would be used in a study evaluating diagnostic accuracy with expert 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

Not applicable. This device is a bone grafting material, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance 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 algorithm or AI device.

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

For the "clinical performance," the ground truth is indirectly based on outcomes data from the "device marketing and complaint history" and the "relevant clinical literature" (which would detail clinical outcomes in patients). For the technical characteristics (biocompatibility, sterilization, pyrogenicity, packaging), the ground truth is established by adherence to international standards (e.g., ISO, ASTM) and in vitro or in vivo test results demonstrating compliance.

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 above, this is not an AI/machine learning device.

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-Augmentation or reconstructive treatment of the alveolar ridge.
-Filling of periodontal defects.
-Filling of defects after root resection, apicocetomy, 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 Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
-Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Cytrans Granules is composed of carbonate apatite. The material of Cytrans Granules has been formulated in terms of carbonate apatite content to the mineral content of natural bone. As Cytrans Granules is completely synthetic, there are no animal derived ingredients in the formula. Cytrans Granules is gradually resorbed and eventually replaced with new bone. Resorption is by osteoclasts under acidic conditions. Cytrans Granules is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. It is sterilized via gamma irradiation and will be marketed/sold in sterile vials for single use.

The provided text describes the 510(k) submission for Cytrans Granules, a bone grafting material. While it discusses performance testing, it does not explicitly state acceptance criteria in a quantitative table or directly link numerical performance results to specific criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting predefined acceptance criteria for a novel performance claim.

However, based on the information provided, we can infer the aspects of performance that were evaluated and deemed acceptable for the device to be considered substantially equivalent.

Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance for Cytrans Granules

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for the device's clinical performance are not explicitly stated in the document (which is common for 510(k) submissions focusing on substantial equivalence), the table below infers the performance aspects that were evaluated and found acceptable relative to the predicate devices and general expectations for bone grafting materials. The "Reported Device Performance" column reflects the findings from the non-clinical and clinical studies.

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

• Test Set (Clinical Study):

  • Sample Size: 22 cases (patients) for sinus floor augmentation (excluding 6 cases due to exclusion criteria).
  • Data Provenance: Japan (stated as "three institutions in Japan"). The study was prospective clinical testing.

• Test Set (Animal Studies):

  • Sample Size: Not explicitly stated beyond "a beagle dog model" where "three commercially available bone substitutes" were compared. It implies multiple animals were used, but the exact number is not provided.
  • Data Provenance: Not specified, but generally animal studies typically involve institutional animal care and use committee approval from the research facility.

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

• The document does not explicitly state the number of experts used or their detailed qualifications for establishing ground truth in the clinical study.
• For a clinical study involving sinus floor augmentation and dental implants, it is implicitly understood that the "ground truth" (e.g., successful implant placement, bone formation assessment, complication rates) would be established by qualified dental surgeons and potentially radiologists/pathologists involved in patient follow-up and evaluation (panoramic X-ray, CT imaging, tissue biopsy).
• The study was conducted across "three institutions in Japan," suggesting that multiple clinical professionals were involved in the evaluations.

4. Adjudication Method for the Test Set

• The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1).
• Clinical trials typically involve standardized protocols for evaluation and data collection, and any discrepancies might be resolved by consensus or a senior investigator, but a formal adjudication process beyond standard clinical practice is not mentioned. Outcomes like "success rate...exceeded the level deemed to be effective" suggest a predefined standard, but not a specific adjudication protocol.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This document describes a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Not applicable. This device is a bone grafting material, not an algorithm or AI system. Its performance is evaluated through its biological interaction within the patient's body, not as a standalone software algorithm.

7. Type of Ground Truth Used

• Clinical Study (Sinus Floor Augmentation):
  • Clinical Outcomes Data: Successful implant placement, lack of rotation/movement, implant placement torque, absence of complications.
  • Imaging Data: Opacity on panoramic X-ray and vertical residual bone on CT imaging confirming new bone formation.
  • Pathology/Histology: Tissue biopsy confirming new bone formation in all cases of the two-stage group.
• Animal Studies: New bone formation, bone-to-implant contact ratio (likely assessed histologically and/or with imaging).
• Biocompatibility Testing: Lab-based tests (Cytotoxicity, Sensitization, Genotoxicity, etc.) with established assay endpoints and interpretations.

8. Sample Size for the Training Set

• Not applicable. This is a medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's development involved material science, preclinical, and clinical testing, but not an ML training paradigm.

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

• Not applicable. As there is no training set (for AI/ML), there is no ground truth established for it. The "ground truth" equivalent in medical device development would be the scientific and clinical validation of its material properties, biological interactions, and clinical efficacy through established testing methods and clinical trials.

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OSTEON III is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

• Periodontal/infrabony defects
• Ridge augmentation
• Extraction Sites(implant preparation/ placement)
• Sinus lifts
• Cystic cavities

This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (ß-TCP). This product presents an interconnected porous structure, similar to that human cancellous bone. This product is available as irregular shape particle of size 0.2~2.0mm. It is sterilized by gamma-radiation.

The provided text is a 510(k) summary for a medical device called OSTEON III. It describes the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence, but it does not provide the details requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not contain any information about:

1. A table of acceptance criteria and reported device performance for clinical endpoints. It has a table comparing technological characteristics (composition, physical properties) to predicate devices, and lists biocompatibility and performance bench tests conducted, but not acceptance criteria for clinical outcomes.
2. Sample size used for a test set or data provenance for a clinical study. The document only references non-clinical testing.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance. (This device is a bone grafting material, not a software algorithm).
7. Type of ground truth used for a clinical study.
8. Sample size for a training set. (Again, this relates to an algorithm, which OSTEON III is not).
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

• Intended Use and Indications for Use: OSTEON III is for bone grafting to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, similar to its predicates.
• Technological Characteristics: Comparison of main materials (HA and β-TCP), device design (interconnected porous structure), composition, and physical properties (porosity, pore size, particle size, Ca/P ratio, crystallinity).
• Biocompatibility Testing: A list of ISO 10993 tests performed (Cytotoxicity, Sensitization, Pyrogenicity, Intracutaneous reactivity, Systemic toxicity, Subchronic toxicity, Genotoxicity-Ames, Genotoxicity-Micro nucleus, Implantation, Genotoxicity-Chromosomal aberration, Endotoxin (LAL)). The results are stated as showing the materials are non-toxic and non-sensitizing.
• Performance Bench Testing: A list of engineering tests like Visual Test, Size, Capacity, Density, Trace Elements, Ca/P ratio, Crystalline phase Composition, Crystallinity, Morphology & Surface Characteristics, Water Solubility, Elution Test (pH, Pb), Potassium permanganate consumed, Ultraviolet rays absorption spectrum, Resorption, Particle size distribution, Compressive strength, Shear and Elastic modulus. The document states "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON III met the established specifications necessary for consistent performance according to its intended use."

In summary, the provided document is a 510(k) summary for a bone grafting material, not a clinical study report for an AI/software device. Therefore, it does not contain the information requested in your prompt regarding clinical acceptance criteria, study design, or expert consensus details.

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ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. Typical uses include:

• Periodontal / infrabony defects
• Ridge augmentation (sinusotomy, osteotomy, cystectomy)
• Extraction sites (ridge maintenance/augmentation, implant preparation/ placement)
• Sinus lifts
• Cystic cavities
• Oral and maxillofacial augmentation

ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material. It is resorbable and has a porous structure with a particle size of 90-710 micron. It is processed by thermal treatment to bond the chemical components together. It is packaged in a sealed glass vial containing 1 gm (1cc) of SCPC particles, sealed in an aluminum sterilization pouch, and sterilized by Gama radiation.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) premarket notification approval letter for a medical device (ShefaBone SCPC Resorbable Bone Graft) and includes a summary comparing it to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

Ask a specific question about this device