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BoneGen-TR is indicated for use as follows:

1. By itself in bone regeneration procedures
2. Mixed with other bone graft materials (e.g. PRP, bone allograft, bone xenograft, demineralized freeze dried bone and/or a pure calcium sulfate based bone graft material)

Oral Surgery: Post-extraction.
Periodontics: Infra-osseous defects.
Endodontics: Apioectomy, Root perforations, Open apices.
Implantology: Dehiscences, fenestrations, sinus lifts.

BoneGen - TR is manufactured by BioLok-International Inc. It is a composite of medical grade calcium sulfate hemihydrate and poly (1 lactic acid) in a 96:4 ratio. It is produced in pellet form: the size of pellets ranging from 425 - 850 microns. This composite undergoes slower degradation than calcium sulfate, overcoming the occasional disadvantage of rapid degradation of the pure medical grade calcium sulfate hemihydrate. It has a half-life of approximately 60 days and is usually completely degraded by 120 days. It can be used as a bone graft material on its own or it can be combined with a pure medical grade calcium sulfate hemihydrate bone graft material such as BoneGen. BoneGen - TR will be presented in 1.5 gram packages. Bony defects can be packed with BoneGen - TR pellets and can be closed with calcium suffate based, absorbable polymer based, collagen based or ePTFE based barriers. With time, BoneGen - TR pellets undergo degradation and is replaced by a calcium phosphate "trellis" that stimulate bone growth in the defect.

The provided text describes the 510(k) summary for BoneGen-TR, a bone filling augmentation material. While it outlines the device's composition, intended use, and substantial equivalence to predicate devices, it does not contain information regarding traditional "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, nor does it detail a clinical study proving such performance specifications.

Instead, the provided text focuses on:

• Chemical composition testing: Ensuring the material meets specified purity and biocompatibility standards.
• Literature review: Documenting the existing use of its components in bone grafting.
• In vitro degradation profile testing: To understand its breakdown characteristics.
• Animal experiment: To study its function as a bone graft material compared to a predicate device.

Therefore, many of the requested fields cannot be answered based on the provided input.

Here's a breakdown of what can and cannot be extracted:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative clinical performance metrics (e.g., success rate, bone volume increase, healing time with specific thresholds). The acceptance criteria were more related to chemical properties, degradation rate, and biocompatibility.
     • Chemical purity (USP NSF 18, ASTM Standard F2224-03).
     • Biocompatibility (ISO 10993-1).
     • Degradation rate (half-life of approximately 60 days, complete degradation by 120 days).
   • Reported Device Performance:
     • Satisfied chemical purity as specified by ASTM Standard F2224-03.
     • Certified biocompatibility to ISO 10993-1 requirements.
     • Half-life of approximately 60 days, usually completely degraded by 120 days.
     • Functioned as a bone graft material comparable to the predicate device in an animal study.

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

   • Test Set Sample Size: Not specified for the animal experiment.
   • Data Provenance: The animal experiment was "conducted to study the function of BoneGen-TR as a bone graft material." Location and retrospective/prospective nature are not described in the provided text.

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/Not mentioned, as the study described is an animal experiment.

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

   • Not applicable/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 device is a bone filling material, 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 device is a bone filling material, not an algorithm.

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

   • For the animal study: The "ground truth" would be determined by histological analysis, micro-CT, or other animal model-specific assessments of bone regeneration and degradation, compared to the predicate device. The text states "function...as a bone graft material."

8. The sample size for the training set:

   • Not applicable. This document is about a medical device material, not a machine learning model.

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

   • Not applicable.

Summary of Acceptance Criteria and Device Performance (based on available information):

The document primarily states that the device was found substantially equivalent to predicate devices based on these tests and literature, which is the primary "acceptance criterion" for 510(k) clearance.

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