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VertaPlex HV Radiopaque Bone Cement is indicated for the fixation of patholoqical fractures of the vertebral body usinq vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

VertaPlex® HV Radiopaque Bone Cement is comprised of a liquid component and powder component which when mixed together polymerize to form a hardened acrylic polymer. The mixture is in a pourable and injectable state for a period of time, before it cures to form a hardened structure, capable of long-term load support and bone augmentation in the treatment of symptomatic osteoporotic vertebral compression fractures.

The powder component of VertaPlex® HV Radiopaque Bone Cement is EO(Ethylene Oxide) sterilized and is packaged in a polyethylene/foil pouch while the liquid monomer is aseptically filled into an amber glass ampoule which is EO sterilized. The device contains the following components: Polymer powder (14g), Monomer liquid (9.5ml), and Barium Sulfate (6g

The provided document describes a 510(k) premarket notification for the Stryker® VertaPlex® High Viscosity (HV) Radiopaque Bone Cement. The submission seeks to expand the indications for use of the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This submission is for an expanded indication for a previously cleared device. The focus of the "study" is to demonstrate safe use in the expanded anatomical area (sacrum) and procedure (sacroplasty), primarily concerning the risk of cement extravasation, rather than proving the overall effectiveness of the bone cement for fracture fixation. The primary comparator is the predicate device, and the demonstration of substantial equivalence relies heavily on the fact that the underlying technology and composition remain unchanged.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of quantitative acceptance criteria for device performance. Instead, the "acceptance criteria" are implied by demonstrating that the expanded indications for use, particularly for the sacrum and sacroplasty, do not introduce new safety or effectiveness concerns, specifically regarding extravasation. The general acceptance criterion is demonstrating substantial equivalence to the predicate device, meaning the new indication is as safe and effective as the predicate.

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

• Sample Size: The document refers to "the cadavers included in this study" but does not specify the exact number of cadavers used in the cadaveric study.
• Data Provenance: The study was a non-clinical cadaveric study. The country of origin is not specified, but it's a Stryker Instruments submission, likely conducted or overseen in the US.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth within the cadaveric study itself. However, it does state that the study aimed to demonstrate safety when the procedure "is performed with meticulous imaging guidance by a physician who is trained and experienced in vertebral augmentation and acetabuloplasty." This implies that the study was conducted or observed by such qualified personnel, but they are not explicitly called "experts for ground truth." The "ground truth" here is the direct observation of extravasation or lack thereof in the cadavers.

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

The document does not mention any adjudication method for the cadaveric study. The assessment of extravasation appears to be direct observation or imaging during the study.

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, an MRMC comparative effectiveness study was not done. This submission is for bone cement, not an AI-powered diagnostic or assistive device.

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

No, a standalone algorithm-only performance study was not done. This is not an AI device. The cadaveric study investigated the physical performance (extravasation) of the bone cement when applied by human operators following specific surgical techniques.

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

For the cadaveric study, the ground truth for "no instances of cement extravasation" was likely established through direct observation and/or post-procedure imaging (e.g., CT evaluation) of the cadaveric specimens, possibly with expert interpretation of these observations/images. This is a direct physical assessment rather than an expert consensus on interpreting indirect data.

8. The sample size for the training set

Not applicable. This submission describes a non-AI medical device (bone cement) and does not involve machine learning models with training sets.

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

Not applicable. As above, there is no training set for this device.

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