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TricOs A 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 A 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 A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

TricOs A 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 document describes a 510(k) premarket notification for the "TricOs A Resorbable Bone Substitute." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them in the way a new, high-risk device might.

Here's an analysis based on the provided text, addressing your questions where possible:

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., specific percentages for success, adverse event rates, or precise mechanical properties) for the TricOs A Resorbable Bone Substitute as a distinct set of performance targets. Instead, the core of the submission is to demonstrate that TricOs A is substantially equivalent to its predicate device, TricOs T, with regard to technological characteristics, performance, and intended use.

The "performance" described is in comparison to the predicate, and is generally qualitative, focusing on its function as a bone void filler and its ability to support bone in-growth and resorption.

Detailed Study Information:

The document describes non-clinical studies to support substantial equivalence. It does not describe a clinical study in humans or a multi-reader multi-case (MRMC) comparative effectiveness study, as it's not a diagnostic AI device.

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

   • Test Set (Animal Studies):
     • Skeletal System: A "rabbit femoral condyles model" was used. The specific number of rabbits or defect sites is not specified in the provided text.
     • Oral and Maxillofacial Region: A "sinus lift animal model study" was used. The specific number of animals or sites is not specified in the provided text.
   • Data Provenance: Animal studies. The country of origin of the data is not specified. The studies are assumed to be prospective as part of the device evaluation.

2. 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 document. For animal studies, the "ground truth" would typically be based on histological analysis, imaging, and possibly biomechanical testing performed by veterinary pathologists, researchers, or specialists in orthopedics/maxillofacial surgery.

3. Adjudication method for the test set:

   • This information is not provided.

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:

   • No. This device is a bone void filler, not an AI-powered diagnostic tool. Therefore, an MRMC study is not applicable and was not performed.

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

   • Not applicable. This device is a physical medical device (bone substitute), not a software algorithm.

6. The type of ground truth used:

   • For the animal studies, the "ground truth" likely involved:
     • Histology: Microscopic examination of tissue sections to assess bone formation, integration, and resorption of the material.
     • Imaging: X-rays, micro-CT scans, or other imaging modalities to assess bone density, defect filling, and integration.
     • Functional/Biocompatibility Testing: Assays to confirm non-toxicity and biological compatibility.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device involves product development, formulation, and manufacturing process optimization, not data-driven algorithmic training.

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

   • Not applicable. As above, there is no "training set" in the context of AI/ML for this device. The "ground truth" for the predicate device's prior clearance and the current device's development would be based on established scientific and regulatory standards for biocompatibility, material properties, and performance in animal models.

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