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TricOs T Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs T Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

TricOs T Resorbable Bone Substitute consists of an inorganic calcium phosphate scaffold that is mixed with a heterologous human fibrin matrix prior to application. The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure, and acting as a three-dimensional matrix that supports the in-growth of bone.

The provided text describes a 510(k) premarket notification for a medical device called TricOs T™ Resorbable Bone Substitute. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and device performance through a detailed clinical study with numerical metrics. Therefore, many of the requested elements for describing such a study are not explicitly present in the provided document.

However, I can extract information related to the study conducted to support the expanded indication.

Here's the information derived from the provided text, addressing your questions to the best of its ability:

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

The document does not specify quantitative acceptance criteria (e.g., specific percentages, thresholds for bone growth, strength, etc.) or report numerical device performance metrics against such criteria. The "assessment of nonclinical data" section states that the device's performance has been addressed by comparative testing. The conclusion states the device "performs well" and is "as safe and effective as the predicate devices."

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

• Sample Size: Not specified in the document. It mentions "a sinus lift animal model study."
• Data Provenance: The study was conducted on "a sinus lift animal model." No country of origin is specified. The study design appears to be prospective (pre-clinical testing for regulatory 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. This was an animal model study, not a human reader study requiring expert interpretation of diagnostic images. The "ground truth" would likely be histological analysis of the animal tissue, performed by veterinary pathologists or similar specialists, but this is not detailed in the provided text.

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

Not applicable. This was an animal model study, not a human reader 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

No, an MRMC comparative effectiveness study was not done. The study described is an animal model study to demonstrate performance for a bone void filler.

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

Not applicable. This device is a bone void filler, not an AI algorithm. The performance evaluation was of the physical device in an animal model.

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

The ground truth would likely be established through pathology (histological analysis) of the animal model tissue to assess bone ingrowth and resorption of the material, but this is not explicitly stated in the document.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. The "training set" concept does not apply.

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

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

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TricOs T is indicated for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T is a bone void filler without initial mechanical properties, therefore rigid fixation techniques may often be recommended.

TricOs T is intended to be packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, TricOs T is resorbed and replaced with bone during the healing process.

Fibrin matrix without the HA/TCP granules is not indicated for use as a bone void filler.

TricOs T is a resorbable bone substitute that is replaced over time by newly formed bone. TricOs T consists of an inorganic calcium phosphate scaffold (HA/TCP granules) combined with a heterologous human fibrin matrix. The fibrin matrix acts as a 3D matrix and enhances the handling of the product by making it moldable and allows it to hold its shape.

This appears to be a 510(k) summary for a medical device called TricOs T Bone Void Filler, submitted to the FDA in 2005. It describes the device's intended use, technological characteristics, and claims substantial equivalence to predicate devices, but does not contain the information requested in your prompt regarding acceptance criteria and a study proving those criteria.

Specifically, the document states:

• "Nonclinical tests: TricOs T has been tested in in vivo and in vitro studies that document safety and effectiveness equivalent to that of the predicate devices."
• "Substantial Equivalence Information: The intended use, composition, biocompatibility and select performance properties of TricOs T are substantially equivalent to commercially available predicate bone void filler products. The product is adequately supported by the substantial equivalence information, materials data, and testing results provided or referenced to in the Premarket Notification."

However, the provided text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (expert consensus, pathology, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory submission summary that asserts the device's safety and effectiveness based on nonclinical tests and substantial equivalence but does not provide the detailed study results, acceptance criteria, or ground truth methodology you're asking for. Such details would typically be found in the full premarket notification (510(k)) document, not just the summary.

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