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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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ABCcolla® Bone Matrix is intended to fill bony voids or gaps of skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of bone structure. ABCcolla® Bone Matrix provides resorbs and is replaced by bone during the healing process.

ABCcolla® Bone Matrix is a bone mineral matrix of porcine origin. ABCcolla® Bone Matrx is physically and chemically comparable to the mineralized matrix of human bone.

This document (K212156) is a 510(k) premarket notification for a medical device called "ABCcolla® Bone Matrix." It concerns a resorbable calcium salt bone void filler.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The document is for a traditional medical device (bone matrix), not an AI/ML driven device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study data for an AI/ML device based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on material characteristics, manufacturing processes, and physical specifications.

To answer your request, I would need a document related to an AI/ML medical device and its validation study.

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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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ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ABCcolla® Bone Graft resorbs and is replaced with bone during the healing process.

ABCcolla® Bone Graft is a bone mineral matrix of porcine origin. ABCcolla® Bone Graft is physically and chemically comparable to the mineralized matrix of human bone.

The provided text describes a 510(k) premarket notification for the "ABCcolla® Bone Graft" device, which is a resorbable calcium salt bone void filler. Here's an analysis of the acceptance criteria and study information, focusing on the lack of specific details regarding a "study that proves the device meets acceptance criteria" as would be expected for an AI/ML device:

Important Note: The provided document is a 510(k) summary for a bone graft medical device, not an AI/ML powered device. As such, concepts like "test set," "human readers," "AI assistance," "ground truth establishment for training set," and "adjudication method" are not applicable in their typical AI/ML context. The document describes traditional medical device testing for substantial equivalence, focusing on biocompatibility, physical properties, and pre-clinical animal performance.

Therefore, many of the requested fields will be marked as "Not Applicable" or "Not Provided" in the context of an AI/ML device. I will extract the relevant information from the document as it pertains to a traditional medical device's testing and acceptance.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ABCcolla® Bone Graft are implicitly set by demonstrating "substantial equivalence" to predicate devices and meeting established medical device standards. The "performance" in this context refers to its physical, chemical, and biological properties, as well as its ability to facilitate bone formation in animal models.

Study Details (Interpreted for a non-AI/ML medical device)

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

   • Test Set Sample Size:
     • For chemical, physical, and in vitro biological tests: Not explicitly stated in terms of sample count (e.g., number of batches, units). These would typically involve multiple samples to establish consistency.
     • For pre-clinical animal performance testing: A "critical-size bone defect model" was performed. The number of animals used is not specified.
   • Data Provenance: The studies were performed by ACRO Biomedical Co., Ltd. (Taiwan). The document does not specify if the studies were retrospective or prospective, but animal studies are typically prospective by nature.

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

   • Not Applicable / Not Provided. For a bone graft device, "ground truth" is established through standardized laboratory analyses (e.g., chemical assays, physical measurements) and histological examination of animal tissue, performed by qualified scientists and pathologists, rather than expert clinicians rendering a diagnostic opinion. The number of such specialists is not specified.

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

   • Not Applicable. Adjudication methods like 2+1 are relevant for interpreting ambiguous diagnostic images or clinical scenarios, typically in studies involving human readers or AI. For the described medical device testing, results are derived from objective measurements, biochemical analyses, and histological assessments in animal models.

4. 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 graft, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance comparison would be performed.

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

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

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

   • For chemical and physical properties: Analytical measurements against established standards (e.g., hydroxyapatite content, porosity).
   • For biocompatibility: Adherence to ISO 10993 series standards, which involves evaluating cellular responses, systemic toxicity, etc.
   • For pre-clinical animal performance: Histological evidence of new bone formation and healing in the critical-size bone defect model, likely compared to control groups or expected healing patterns. This would involve pathology and quantitative analysis of bone growth.

7. The sample size for the training set:

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

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant for this device.

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