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Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time

I am sorry, but the provided text is for a medical device called "Vertebroplastic™ Radiopaque Bone Cement," which is a polymethylmethacrylate (PMMA) cement used for filling spinal vertebral body defects. This is a physical product and not an AI/ML powered device. As such, the concepts of "acceptance criteria for an AI model," "sample size for test set," "ground truth," "MRMC study," or "training set" are not applicable to this document.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance studies and acceptance criteria as would be found for an AI/ML device.

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The KyphX® HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

Like the predicate device, KyphX® HV-R bonc coment 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 pcroxide as an initiator. The liquid component consists ી 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 for a medical device, the KyphX® HV-R bone cement. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and a detailed performance study as would be seen for new or high-risk devices.

Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, detailed study design for proving performance, and ground truth establishment is not available in this document.

Here's a breakdown of what can be extracted and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Information Not Provided in the Document:

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

• This document does not detail specific "test sets" for a clinical study in the way an AI/software device would. The comparisons are primarily based on material properties, biocompatibility, and intended use equivalence to a predicate device. If mechanical or biocompatibility tests involved samples, those sample sizes are not specified.

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 in this context. Ground truth establishment for a diagnostic AI is not part of a bone cement's 510(k) submission.

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

• Not applicable.

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 device is bone cement, not an AI or software product.

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

• Not applicable.

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

• The "ground truth" here is the established performance and safety profile of the predicate device (Surgical Simplex®P) and adherence to recognized standards (ISO 5833:2002, ISO-10993, FDA Blue Book Memorandum #G95-1). It's not about a diagnostic outcome for a patient.

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.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the KyphX® HV-R bone cement meets its (implicit) acceptance criteria is a direct comparison study against a legally marketed predicate device, Surgical Simplex® P. This comparison focused on:

• Chemical Composition: Comparing the exact percentages of components (PMMA copolymer, barium sulfate, benzoyl peroxide in the powder; methyl methacrylate, N,N-dimethyl-p-toluidine, hydroquinone in the liquid). The provided table (Table 5-1) serves as the evidence for this.
• Mechanical Properties: Testing performed in accordance with ISO 5833:2002, demonstrating "substantial equivalence" to the predicate. (Specific test results are not detailed in this summary).
• Biocompatibility: Evaluation against FDA Blue Book Memorandum #G95-1 and comparison to the predicate as defined by ISO-10993, demonstrating "substantial equivalence."
• Sterilization: Verification of sterility and non-pyrogenicity, with specific details on methods and SALs.
• Intended Use: Clinical information was reviewed to confirm that the new device's intended use is substantially equivalent to the predicate's and does not negatively impact safety or effectiveness.

The conclusion is that the KyphX® HV-R bone cement is substantially equivalent to the predicate device based on these comparisons, allowing it to be cleared for market without requiring a full PMA (Premarket Approval) application.

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