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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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The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants.

Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants.

The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Laser-Lok™ surface treatment for dental implants:

The provided 510(k) summary focuses on establishing substantial equivalence for a line extension (a surface modification) to an already cleared device. As such, the testing and claims are primarily directed at demonstrating that the new surface treatment does not negatively impact the safety and effectiveness of the base implant, and that it maintains or improves certain characteristics.

The summary does not explicitly define specific numerical acceptance criteria in the way a typical diagnostic AI/ML device might (e.g., minimum sensitivity or specificity thresholds). Instead, the acceptance is based on demonstrating mechanical equivalence and beneficial biological responses, primarily through existing literature and animal/clinical testing which is summarized qualitatively.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing: Not explicitly stated. The document refers to "Results from an independent lab" but does not give sample sizes for these tests. Data provenance is implied to be from a testing laboratory.
• Animal Studies: Not explicitly stated, but referenced generally as "animal...testing." One literature reference (Ricci et al.) relates to a chapter in "Bone Engineering," and the other (Weiner et al.) is a presentation from a 2003 meeting and pending publication. These are likely retrospective (i.e., refers to previously published or presented work).
• Clinical Testing: Not explicitly stated. The document mentions "clinical testing" but provides no details on patient numbers, demographics, or study design. Likely retrospective (referring to existing data/literature).
• Finite Element Analysis (FEA): Not applicable for sample size as it is a computational method.

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

This information is not provided in the summary. For a device like this, ground truth would typically be established by objective measurements (e.g., mechanical testing, histological analysis in animal studies, clinical outcomes observed by dental professionals). The summary does not detail the specific methods for ground truth establishment or expert involvement for the test set specifically. The cited literature involves various researchers (Ricci, Charvet, Frenkel, Chang, Nadkarni, Turner, Alexander; Weiner, Simon, Ehrenberg, Zweig, Ricci), who would be considered experts in their respective fields (e.g., biological engineering, oral and maxillofacial implants).

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the types of studies referenced (mechanical, animal, clinical observations/literature review rather than human-read image interpretation).

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 type of study is relevant for AI/ML diagnostic devices where human readers interpret images or data. The Laser-Lok surface treatment is a physical modification to an implant, not an AI/ML diagnostic tool.

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

No, a standalone AI algorithm performance study was not done. This device is a physical medical device, not an algorithm.

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

Based on the references and nature of the device, the ground truth types would likely include:

• Mechanical measurements: For static and dynamic strength.
• Histological analysis / Biological data: For soft tissue attachment, epithelial down-growth, and bone response (likely from animal studies, pathology).
• Clinical observations / Outcomes data: For in-vivo performance regarding tissue integration and overall implant success (implied from "clinical testing").
• Literature/Expert consensus: The cited references support the claims, implying that the ground truth is established through accepted scientific and clinical findings.

8. The sample size for the training set

This information is not provided and is not applicable as this device does not involve an AI/ML algorithm that requires a "training set."

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

This information is not provided and is not applicable as this device does not involve an AI/ML algorithm that requires a "training set."

Summary of Limitations in the Provided Text for This Request:

The provided 510(k) summary is typical for a medical device modification rather than an AI/ML diagnostic tool. Therefore, many of the requested elements (like explicit numerical acceptance criteria, specific sample sizes for particular studies, details on expert ground truth establishment and adjudication, or AI-specific studies) are either not present or not fully detailed. The focus is on demonstrating substantial equivalence through a combination of mechanical testing, finite element analysis, and referencing animal and clinical studies, often drawing on existing literature and prior clearances.

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The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

The Silhouette™ (hex-top) and Silhouette ™ IC (internal connectivit) incorporate a self-tapping tapered implant design that provides lateral compression of the osteotomy site to meorporate a son-apping tapping aller and is flat in the lower supporting plane of the thread, passing compression forces to the bone and eliminating shear forces common to symmetrical the thead implants. The screw thead portion of the implants are surfaced roughened with Osseo-I ok™ per Bio-Coat, Inc. specifications. Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment.

The provided text is related to a 510(k) submission for a dental implant system. It contains information about the device's description, indications for use, and a summary of testing. However, it does not provide the specific details required to complete your request for acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document states that "sufficient mechanical static and dynamic strength" was found, but it doesn't quantify what "sufficient" means (e.g., specific load values, fatigue cycles). It also mentions "biocompatibility" but doesn't list the criteria or outcomes.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all crucial details for a comprehensive study description that are entirely absent from this 510(k) summary. The summary focuses on regulatory compliance based on existing guidelines and general statements about testing.

Therefore, I cannot fulfill your request as the necessary data is not present in the provided text.

To give you an idea of what a good answer would look like if the information were available, here's a template:

Acceptance Criteria and Study Details (Hypothetical, based on typical medical device submission)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Mechanical Testing: 15 implants per test condition (e.g., 15 for static, 15 for dynamic).
  • Animal Study: 10 animals, 2 implants per animal.
  • Clinical Study: 100 patients.
• Data Provenance:
  • Mechanical Testing: Conducted in a certified independent laboratory in the USA.
  • Animal Study: Prospective study conducted in Germany.
  • Clinical Study: Prospective, multi-center clinical trial conducted across 3 sites in the USA and 2 sites in Canada.

3. Number and Qualifications of Experts for Ground Truth

• Mechanical & Biocompatibility: No expert ground truth needed; based on objective measurements.
• Animal Study (Histomorphometry): 3 veterinary pathologists, each with >15 years of experience in bone histology and implant evaluation.
• Clinical Study (Outcome Adjudication): 2 independent dentists (oral surgeons) with >10 years of experience in implantology, blind to treatment groups.

4. Adjudication Method for Test Set

• Mechanical & Biocompatibility: N/A (objective measurements).
• Animal Study: Each pathologist independently evaluated all slides. Any discrepancies (e.g., >10% difference in BIC measurement) were resolved by a consensus meeting involving all three pathologists.
• Clinical Study: 2+1 adjudication. Two dentists independently reviewed all patient outcomes. If their assessments agreed, that was the final outcome. If they disagreed, a third senior implantologist (not involved in initial reviews) would review the case and make the final determination.

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

• No MRMC study was performed for this device, as its primary evaluation was based on objective mechanical, biological (animal), and clinical (human outcomes) performance rather than diagnostic interpretation assisted by AI.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) study was performed. This is a hardware medical device (dental implant) and does not involve an AI algorithm for diagnostic or interpretative purposes.

7. Type of Ground Truth Used

• Mechanical Testing: Objective physical measurements (e.g., force, displacement, cycle count).
• Biocompatibility: In-vitro laboratory assays (e.g., cell viability, leachables testing).
• Animal Study: Histomorphometric analysis of tissue sections.
• Clinical Study: Patient outcomes as defined by the study protocol (e.g., implant survival, peri-implantitis incidence, marginal bone loss measured from radiographs).

8. Sample Size for Training Set

• N/A. As this is a hardware device without an AI component, there was no "training set."

9. How Ground Truth for Training Set was Established

• N/A. Not applicable for a hardware device.

This hypothetical example illustrates the detail typically expected in such a request, showing what specific information is missing from the provided 510(k) summary. The provided document is a high-level summary for regulatory clearance, not a detailed scientific study report.

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