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Vertaplex HV Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Vertaplex HV is Polymethyl Methacrylate cement used for the treatment of painful vertebral fractures based on the predicate device Stryker Vertaplex PMMA Radiopaque Bone Cement (Vertaplex). Vertaplex HV can be injected directly into the fractured vertebral body by either Vertebroplasty or Kyphoplasty procedures to relieve pain.

The provided text describes a 510(k) summary for the Stryker Vertaplex HV, a PMMA Bone Cement. The submission focuses on demonstrating substantial equivalence to a predicate device, the Stryker Vertaplex Radiopaque Bone Cement (K072118), rather than presenting a study proving performance against defined acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, many of the requested categories related to AI device performance evaluation (such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and standalone performance) are not applicable to this document.

Here's an attempt to answer the questions based only on the provided text, primarily focusing on the "Safety and Effectiveness" section of the 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This document describes a 510(k) submission for a bone cement device, not an AI device. The testing mentioned refers to physical/chemical properties and performance, not evaluation against a test set of data like an AI algorithm. No information about data provenance (country of origin, retrospective/prospective) is provided as it's not relevant to this type of device submission.

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

• Not applicable. Ground truth establishment by experts for a test set is relevant for AI/algorithm performance evaluation. This document describes a traditional medical device submission, where "ground truth" would relate to laboratory testing results or clinical outcomes, not expert interpretation of data for an algorithm.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations when establishing ground truth for evaluating AI/algorithm performance. This is not mentioned as it's not applicable to this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretive devices involving human readers. This document is for a bone cement, not an AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This question pertains to AI algorithms. The device described, Stryker Vertaplex HV, is a physical bone cement, not an algorithm.

7. The Type of Ground Truth Used

• For the purpose of demonstrating substantial equivalence for this bone cement, the "ground truth" implicitly relies on physical, chemical, and mechanical testing results (e.g., meeting specifications for strength, setting time, radiopacity) that are deemed similar or equivalent to the predicate device. The document states, "Testing shows that the device meets similar performance specifications as those for the predicate device."

8. The Sample Size for the Training Set

• Not applicable. This question refers to AI model training. The document describes a physical medical device.

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

• Not applicable. This question refers to AI model training. The document describes a physical medical device.

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