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KyphX HV-R® Bone Cement is indicated for the treatment of pathological fractures of the verteral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

KyphX HV-R® Bone Cement is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The provided text is a 510(k) premarket notification summary and an FDA clearance letter for a bone cement, not a study evaluating a device's performance against acceptance criteria in the context of AI/software. Therefore, it does not contain the specific information requested in the prompt, such as:

• A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc., for a diagnostic AI).
• Sample sizes for test or training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC study details.
• Standalone performance or type of ground truth for an AI device.

The document describes the KyphX HV-R® Bone Cement and focuses on its substantial equivalence to predicate devices, its intended use, and its physical/chemical properties.

It mentions a "study" in the context of "Testing was conducted to verify the KyphX HV-R® Bone Cement performance for in vivo applications in support of the labeling changes." However, this is not an effectiveness study as typically performed for AI or diagnostic devices, but rather performance testing related to the physical properties of the bone cement.

Here's what can be extracted, acknowledging the mismatch with the prompt's focus on AI/diagnostic device studies:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for clinical performance (like sensitivity or specificity) for a diagnostic device, nor does it report such performance. Instead, it mentions:

• Acceptance Criteria (Implied): The device's performance (specifically handling properties like dough times and hardening times) must be within the "Setting Time specification range."
• Reported Device Performance: "Handling properties (dough times) were assessed on multiple lots of bone cement, including lots that were manufactured at the extremes of the Setting Time specification range. The dough time and hardening time were also measured at various ambient temperatures using bone filler devices, the intended mode of clinical application." The conclusion drawn is that "The results of this testing support the determination of substantial equivalence."

A table formatted for the prompt's request would look like this, but with caveats:

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

• Test Set Sample Size: "multiple lots of bone cement" – specific number not provided.
• Data Provenance: Not specified (e.g., country of origin). The testing is related to manufacturing and physical properties rather than clinical data from patients.
• Retrospective/Prospective: Not applicable in the context of physical property testing for a bone cement.

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

• Not applicable. Ground truth in this context refers to the physical properties of the cement, measured mechanically, not interpretations by human experts for diagnostic purposes.

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

• Not applicable. No expert adjudication was involved for physical property measurements.

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. This is a bone cement, not an AI device.

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

• No. This is a physical medical device (bone cement), not an algorithm.

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

• The "ground truth" for the testing mentioned would be the measured physical properties (e.g., specific dough times and hardening times) of the bone cement, determined through laboratory testing and instrumentation, compared against predefined specifications.

8. The sample size for the training set:

• Not applicable. There is no AI model or training set involved.

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

• Not applicable. There is no AI model or training set involved.

In summary, the provided document describes a 510(k) clearance for a bone cement, focusing on its substantial equivalence through physical property testing, not an AI or diagnostic device evaluation study as anticipated by the prompt's structure.

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