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

Vertaplex is Polymethyl Methacrylate cement used for the treatment of painful vertebral fractures based on the predicate device Spineplex. Vertaplex can be injected directly into the fractured vertebral body by either Vertebroplasty or Kyphoplasty procedures to relieve pain.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, or a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) summary for a medical device (Stryker Vertaplex Radiopaque Bone Cement). It focuses on demonstrating substantial equivalence to a predicate device (Stryker Spineplex Radiopaque Bone Cement).

Here's what the document does state, which is relevant to your request, but doesn't fully answer it:

• Performance Standards: "Stryker Vertaplex has been developed in accordance with the FDA Guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement."" This implies that certain performance characteristics relevant to PMMA bone cement are expected to be met, as per the guidance document. However, the specific acceptance criteria from that guidance are not detailed in this 510(k) summary.
• Safety and Effectiveness: "In vitro testing shows that the device meets similar performance specifications as those for the predicate device." This indicates that some form of testing was done to compare its performance to the predicate, but again, the specific results, acceptance criteria, or a detailed study description are not provided.
• Biocompatibility: "All appropriate biocompatibility tests have been performed on Vertaplex and have met the standard requirements." This confirms biocompatibility testing was performed and met standards, but doesn't specify the tests or criteria.

The 510(k) process primarily relies on demonstrating equivalence rather than exhaustive clinical trials for de novo authorization. Therefore, the detailed study design (like sample sizes, ground truth establishment, MRMC studies, etc.) you're asking about is not typically part of what's presented in a 510(k) summary for this type of device.

Therefore, I cannot populate your table or answer most of your detailed questions because the provided text does not contain that information.

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