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The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Conduit™ TCP Granules is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Conduit™ TCP Granules are a synthetic material, obtained after high-temperature ceramicization of a mixture of tribasic calcium phosphate. The Conduit™ TCP Granules are composed of interconnected pores occupying approximately 70% of the volume of the implant, and ranging in diameter between 1 and 600 um. Conduit™ TCP Granules come in the form of irregular shaped granules having an average diameter between 1.5 and 3 mm inclusive.

The provided text describes a 510(k) premarket notification for "Conduit™ TCP Granules," a bone graft substitute. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed independent study with specific acceptance criteria and performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, explicit numerical acceptance criteria are not stated, nor is a direct table showing performance against such criteria. The submission relies on "Physico-Chemical Characterization testing and animal testing" to demonstrate equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The text mentions "Physico-Chemical Characterization testing and animal testing" were conducted. However, specific sample sizes for these tests are not provided.

• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective for the animal testing. Physico-chemical characterization is typically lab-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this 510(k) submission. For bone graft substitutes like Conduit™ TCP Granules, "ground truth" is typically established through:

• Standardized material characterization tests (e.g., chemical composition, porosity measurements).
• In vivo animal studies where outcomes are assessed histologically, radiographically, and sometimes mechanically by veterinary pathologists or specialized researchers.
• Clinical outcomes from predicate devices.

Expert consensus, in the sense of multiple human readers interpreting results, is not typically the primary method for establishing "ground truth" for the fundamental safety and efficacy of such a material for a 510(k) clearance based on substantial equivalence.

4. Adjudication Method for the Test Set

This is not applicable as there are no human readers or interpretations described that would require an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or described in this submission. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a bone graft substitute, not an imaging AI.

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

This question is not applicable to the "Conduit™ TCP Granules" device. This is a material device (bone graft substitute), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for showing the device meets its intended use and is safe/effective is established through:

• Physico-Chemical Characterization: Measurements of material properties like composition, porosity, and granule size, which are objectively verifiable.
• Animal Testing: In vivo studies to assess biocompatibility, resorption, and bone ingrowth. The "ground truth" in these studies would typically involve histopathology (examining tissue samples under a microscope) and potentially radiographic imaging (X-rays, CT scans) interpreted by trained veterinary pathologists and researchers.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product (bone graft substitute), not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no training set for this device.

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