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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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ORTHOSS® is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). ORTHOSS® can be used with autograft as a bone graft extender in a posterolateral spine fusion. These osseous defects may be surgically created or be the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device resorbs and is replaced with bone during the healing process.

Orthoss® is an inorganic bone matrix, manufactured from bovine bone, with an interconnected macro- and microporous structure that supports the formation and ingrowth of new bone. Over time, Orthoss® is partially remodeled by osteoclasts (physiological remodeling). The single-use product is provided sterile (via gamma irradiation) in block (1 x 1 x 2 cm and 2 x 2 x 1.3 cm) or granular (1 - 2 mm and 2 - 4 mm) form in double-blister packs or glass vials in a blister pack, respectively.

This document discusses the 510(k) premarket notification for Orthoss®, a resorbable calcium salt bone void filler. It describes the device, its indications for use, comparison to a predicate device, and performance data provided to support its substantial equivalence.

Here's an analysis to extract the requested information:

Analysis of the document for Acceptance Criteria and Study Details:

The document describes a medical device (Orthoss®), not an AI/software device. Therefore, the questions related to AI performance metrics (e.g., human reader improvement with AI, standalone AI performance, training set details, expert ground truth establishment for AI) are not applicable to this submission.

The "acceptance criteria" for this device are primarily demonstrated through substantially equivalent (SE) determination to a predicate device, supported by performance data demonstrating safety and effectiveness. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance studies, particularly an animal study for an extended indication.

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

Since this is not an AI device, there isn't a table of statistical performance metrics like sensitivity/specificity for disease detection. Instead, "acceptance criteria" are implied by the demonstration of substantial equivalence across various aspects.

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

• Test Set Description: The "test set" here refers to the animal study conducted to support the extended indication.
• Sample Size: The document states "Rabbits were randomized to receive Orthoss®, MASTERGRAFT® Resorbable Ceramic Granules, or autograft control." (Page 5). It does not specify the exact number of rabbits in each group or overall.
• Data Provenance: The study used a "validated Boden rabbit spinal fusion model." (Page 5). This is a prospective animal study. The country of origin of the data is not explicitly stated but implies a controlled laboratory setting.

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

• This question is Not Applicable in the context of this device. The ground truth for the animal study (bone healing, fusion, etc.) was established through direct observation, radiographic analysis, micro-computed tomography, and histological analysis of the animal tissue, not by human expert readers interpreting images for disease diagnosis. The evaluation was primarily objective measurements and pathological assessment.

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

• Not Applicable. As this is an animal study involving direct biological and imaging measurements (radiographs, micro-CT, histology, manual palpation), there is no mention of "adjudication" in the sense of multiple human readers resolving disagreements on interpretations. The results were based on direct observation and analysis by the researchers and pathologists involved in the study.

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 void filler), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• For the animal study: The ground truth was established through a combination of:
  • Radiographic appearance (direct imaging evidence)
  • Micro-computed tomography (detailed 3D imaging of bone structure)
  • Histology (microscopic examination of tissue, considered the gold standard for bone formation and remodeling)
  • Manual palpation (a physical assessment of fusion rigor)
  • Multidirectional flexibility measurements of the spine.

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. No training set was involved.

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Anorganic Bone Mineral with Collagen in Delivery Applicator 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 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 conjuncts 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.

Anorganic Bone Mineral with Collagen in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone with the addition of bovine type I collagen, pre-loaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. The type I collagen component is derived from bovine Achilles tendon. Anorganic Bone Mineral with Collagen in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.

The provided document is a 510(k) summary for the "Anorganic Bone Mineral with Collagen in Delivery Applicator" device. It describes the device, its indications for use, and a comparison with predicate devices to establish substantial equivalence. However, it does not contain information typically found in a study proving a device meets specific acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader effectiveness for an AI/ML medical device.

This document describes a bone grafting material and its delivery applicator, a Class II medical device. The focus is on demonstrating substantial equivalence to existing predicate devices through material properties, biocompatibility, sterilization, and functionality. It is not an AI/ML device, and therefore the concepts of "acceptance criteria" in the context of statistical performance metrics, "test set," "training set," "ground truth," "expert adjudication," or "MRMC studies" as they apply to AI/ML devices are not relevant here.

Therefore, I cannot provide the requested information for an AI/ML device.

Here's what I can extract based on the document's content, focusing on non-clinical performance testing:

While not in the format of AI/ML acceptance criteria, the document describes "Non-Clinical Performance Testing" which serves a similar purpose of verifying device performance.

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

Since this is not an AI/ML device evaluation, the "acceptance criteria" are related to physical, chemical, and biological properties, not statistical performance metrics.

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

This information is not applicable in the context of an AI/ML "test set" and statistical performance. For the non-clinical testing:

• Sample sizes for biocompatibility, sterility, and pyrogenicity: Not specified in the document, but understood to adhere to relevant ISO standards (e.g., ISO 10993, ISO 11137).
• Sample size for plunger force: Not specified for how many units were tested.
• Sample sizes for animal studies: "a canine model," "a rabbit femoral condyle defect model," "a rat subcutaneous implantation study." Specific numbers of animals are not provided.
• Data provenance: Not explicitly stated, but assumed to be from internal lab studies and potentially contract research organizations. No country of origin for test data is mentioned. The studies are prospective in the sense that they were conducted for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of an AI/ML device (e.g., disease presence/absence) is not relevant here. The "ground truth" for this device's performance is established by the direct physical, chemical, and biological testing results against predefined specifications and regulatory standards.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

As explained, "ground truth" for AI/ML devices is not applicable. For this device, the "truth" is established by:

• Direct analytical measurements (e.g., plunger force, material composition, physicochemical tests).
• Standardized biological assays (e.g., cytotoxicity, sensitization, pyrogenicity tests).
• Histopathological and physiological observations from animal models of bone regeneration.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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Anorganic Bone Mineral in Delivery Applicator 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 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 conjuncts 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.

Anorganic Bone Mineral in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone without the addition of bovine type I collagen, preloaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.

The document describes a 510(k) premarket notification for a medical device called "Anorganic Bone Mineral in Delivery Applicator". It does not describe a study involving an algorithm or AI.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set sample size, ground truth for training set) are not applicable to this document.

However, I can provide the acceptance criteria and demonstrated performance based on the non-clinical testing described.

1. Table of acceptance criteria and the reported device performance

Additional Non-Clinical Performance Testing:

• Biocompatibility of Sterile Finished Device: Cytotoxicity, irritation, and sensitization tests were performed and demonstrated biocompatibility. (Specific acceptance criteria for these individual tests are not detailed, but the conclusion states they were met.)
• Biocompatibility of Delivery Applicator: Cytotoxicity, physicochemical attributes of a polymeric material, and USP physicochemical tests were performed. (Specific acceptance criteria not detailed, but the conclusion states they were met.)
• Biocompatibility of Anorganic Bone Mineral: Cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, and subacute/subchronic toxicity tests were performed. (Previously submitted and deemed applicable, conclusion states they were met.)
• Sterilization Validation: Performed in accordance with ISO 11137-1. (Implies meeting the SAL 10^-6 requirement.)
• Bench Testing of Delivery Applicator Functionality and Customer Assessment: Performed. (Implies proper functioning of the applicator.)
• Animal Performance Testing:
  • Anorganic Bone Mineral (derived from porcine bone tissue): Tested in an intraoral defect in a canine model.
  • Anorganic Bone Mineral with and without Collagen: Tested in a rabbit femoral condyle defect model.
    (These studies supported the performance of the bone mineral component, which is part of the subject device.)

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, as this document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study. The relevant "tests" involved laboratory-based biocompatibility, sterilization validation, and bench testing, as well as animal studies. The sample sizes for these specific non-clinical tests (e.g., number of animals, number of test samples for material characterization) are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study requiring expert-established ground truth.

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

Not applicable.

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.

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

Not applicable.

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

Not applicable, as this document describes non-clinical performance testing not requiring a clinical "ground truth" as typically defined for diagnostic AI. The "ground truth" for these tests would be the established scientific standards and methods for assessing material properties, biocompatibility, and sterility.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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InterOss® small granules are recommended for:

• 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 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)

InterOss® large granules are recommended for:

• . Augmentation or reconstructive treatment 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)

InterOss® 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.

InterOss® is available in granule form and is packaged in vials or a syringe-like applicator.

InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm).

InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm).

The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting.

During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes.

All InterOss® products are supplied sterile and are intended for single use only.

The provided text describes the regulatory clearance of a bone grafting material called InterOss® and does not contain information about a medical device that relies on AI or offers performance metrics that would typically be described with acceptance criteria like sensitivity, specificity, or AUC, as commonly seen in AI/ML device descriptions.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" here are implied by the standards for bone grafting materials and the equivalence to the predicate devices.

Here's an attempt to structure the information based on the request, reinterpreting "acceptance criteria" as the properties and test outcomes required for substantial equivalence in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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