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Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus™ is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.

Comporus™ is an osteoconductive biodegradable scaffold used as bone void filler. It is manufactured from a mixture of poly-D/L-lactide and hydroxyapatite and provided in granule, block and cylinder forms. They may be pressed into the surgical site by hand. Comporus™ was shown to be biocompatible. Used properly, the implant is resorbed and replaced with natural bone during the healing process. Comporus™ is sterile and intended for single use only. It is radiopaque and has the ability to be modified intraoperatively by trimming or thermal transformation to be adjusted to the shape of a defect.

The provided text details a 510(k) summary for a medical device called Comporus™, a resorbable synthetic bone void filler. This submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria in a quantitative manner. Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not available in the provided document.

Here's a breakdown of what can be extracted and what is missing:

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

Not Available. The document does not specify quantitative acceptance criteria. Instead, it asserts "similar compressive strength to the predicate devices and cancellous bone" and "similar technological characteristics (i.e., design and material)" as the basis for substantial equivalence. No specific performance metrics or thresholds are presented.

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

Not Available. The document mentions "Preclinical testing was performed" but does not provide details on the sample size (number of subjects, defects, or units tested) or the provenance (e.g., country of origin, retrospective/prospective nature) of this test data.

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

Not Available. The document does not describe the establishment of a "ground truth" for a test set, nor does it refer to experts involved in such a process.

4. Adjudication method for the test set

Not Available. As no detailed test set or ground truth establishment is described, no adjudication method 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

Not Applicable. Comporus™ is a bone void filler, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study or AI-related metrics are irrelevant to this device type.

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

Not Applicable. Comporus™ is a physical medical device (bone void filler), not an algorithm or AI system.

7. The type of ground truth used

Not Available. The document asserts "Preclinical testing was performed" and states that "Used properly, the implant is resorbed and replaced with natural bone during the healing process." This implies histological or imaging-based assessment of bone formation in a preclinical setting, but the specific type of ground truth (e.g., detailed pathology reports, quantitative imaging analysis, long-term outcome data) is not elaborated upon.

8. The sample size for the training set

Not Applicable/Available. The concept of a "training set" is relevant for AI/ML devices. As Comporus™ is a physical medical device, not an AI/ML algorithm, no training set is described.

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

Not Applicable/Available. See response to #8.

Summary of what the document does provide regarding the study:

The 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against specific acceptance criteria. Key points related to the "study" are:

• Evidence of Equivalence: The submission asserts that Comporus™ has:
  • The same intended use as predicate devices.
  • The same principles of operation as predicate devices.
  • "Very similar technological characteristics" (design and material) to predicate devices.
  • "Similar compressive strength to the predicate devices and cancellous bone."
  • The minor technological differences do not raise new safety or effectiveness issues.
• Preclinical Testing: "Preclinical testing was performed and demonstrates that the device is substantially equivalent to the predicate." This is a general statement without specific details on the nature, scope, or results of these tests, beyond the assertion of similar compressive strength and the claim that the implant resorbs and is replaced by new bone.
• Biocompatibility: Comporus™ was shown to be biocompatible.

In essence, the study described in this 510(k) summary is a comparative analysis intended to demonstrate that Comporus™ is as safe and effective as existing, legally marketed devices, rather than a de novo study proving its performance against predefined benchmarks.

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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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TruGraft™ BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.

The TruGraft™ BGS Syringe is a device that can be filled with OsteoBiologics, Inc. products: PolyGraft® BGS or PolyGraft® TCP (K030288 and K033707 respectively) or other bone graft substitute. The TruGrafTM BGS Syringe can be provided as a kit configuration. The convenience kit provides the TruGrafTM BGS Syringe loaded (filled) with a variety of bone graft substitutes.

The TruGrafi™ BGS Syringe is a standard piston syringe that consists of a barrel, plunger and removable end cap. The distal end of the barrel is threaded to allow connection to adapters. While without the attachment, the open end allows for filling of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel contents or facilitate in the collection into the barrel of the syringe.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria. The document is a 510(k) summary for a medical device (TruGraft™ BGS Syringe) seeking substantial equivalence to predicate devices, not a performance study.

The text describes:

• The device's intended use and components.
• Its classification and product codes.
• The predicate devices it claims substantial equivalence to.
• Correspondence from the FDA confirming the 510(k) clearance.

It does not contain the following information typically found in a performance study:

1. Acceptance criteria and reported device performance table: No specific performance metrics or thresholds are mentioned.
2. Sample size, data provenance: No test sets, training sets, or data origin (country, retrospective/prospective) are discussed.
3. Number/qualifications of experts for ground truth: There's no mention of experts or ground truth establishment.
4. Adjudication method: Not applicable as no ground truth creation is described.
5. MRMC comparative effectiveness study: No such study is mentioned or implied.
6. Standalone (algorithm-only) performance: The device is a physical syringe, not an algorithm, so this is not applicable.
7. Type of ground truth: Not applicable as no ground truth is discussed.
8. Sample size for training set: No training set is mentioned.
9. How ground truth for the training set was established: Not applicable.

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