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This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes.

The Bone Cement Radio-Opacifier is an additive to be used with Codman Cranioplastic (K873689) to provide radiopacity to the resin and assist in placement and visualization of material.

The provided text describes a 510(k) summary for a Bone Cement Radio-Opacifier. This submission is for a medical device that acts as an additive to provide radiopacity for imaging purposes.

Based on the available information, the device is not an AI/ML-enabled medical device. It's a physical additive (Barium Sulfate, USP) to bone cement to make it visible on X-rays. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for algorithms, sample sizes for AI training/testing, expert adjudication, MRMC studies, and standalone performance, are not applicable.

The document focuses on establishing substantial equivalence to a predicate device (Parallax Tracer Radiopaque Particles) based on identical intended use and performance attributes. The "performance testing" mentioned is likely physical/chemical testing for the radio-opacifier's ability to provide radiopacity and its impact on the functional characteristics of the bone cement.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for performance testing.
• Data Provenance: Not explicitly stated, but assumed to be from internal lab testing performed by Cardinal Health in the US. This is a non-clinical evaluation of a physical product.

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

Not applicable for this type of device. The "ground truth" would be objective measurements of radiopacity or material properties, not expert interpretations of images.

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

Not applicable. Testing would involve objective measurements against specifications, not subjective adjudication of results.

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 is not an AI/ML device.

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

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

7. The type of ground truth used

The "ground truth" in this context would be objective measurements of physical and chemical properties (e.g., radiopacity, set time, mechanical strength after mixing) to demonstrate equivalence to the predicate and ensure the additive doesn't compromise the bone cement's function. No specific type of "ground truth" (like pathology or outcomes data) is mentioned as it's not relevant to this device's function.

8. The sample size for the training set

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

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

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

Summary of Study Type:

This appears to be a non-clinical performance study focused on demonstrating substantial equivalence of a physical medical device (a radio-opacifying additive) to a legally marketed predicate device. The study would involve laboratory testing to compare the physical and functional characteristics of bone cement mixed with the new radio-opacifier against bone cement mixed with the predicate radio-opacifier. The specific tests (e.g., related to radiopacity, setting time, strength) are not detailed but are implied by the claim of "substantially equivalent... with regard to functional characteristics."

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