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

When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® HV High Viscosity Radiopaque Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Vertaplex® HV High Viscosity Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised.

When used without cement, the ES2® Augmentable Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with the Vertaplex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. ES2® Augmentable Spinal System augmented with the Vertaplex® HV High Viscosity Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

VertaPlex® HV High Viscosity Radiopaque Bone Cement is bone cement comprised of a liquid component and powder component which when mixed together polymerize to form a hardened acrylic polymer. The mixture is in an 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 High Viscosity Radiopaque Bone Cement is Ethylene Oxide (EO) 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, Monomer liquid and Barium Sulfate. Accessories to the subject cement device are compatible Stryker cement mixers such the Stryker Autoplex System and the Stryker PCD System.

ES2® Augmentable Spinal System is a gamma sterilized, titanium implantable screw with fenestrations and blocker designed as a stabilization solution for the aging spine. The subject system (screw and blocker) has been developed to provide improved anchorage of pedicle screws with and without Vertaplex® HV High Viscosity Radiopaque Bone Cement during pedicle screw augmentation in vertebrae with reduced bone quality as compared to pedicle screw augmentation in healthy bone.

The provided text is a 510(k) summary for the Stryker Vertaplex® HV High Viscosity Radiopaque Bone Cement and ES2® Augmentable Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technological characteristics, rather than presenting a study proving a device meets specific acceptance criteria based on its performance in a clinical or analytical setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not present in this type of FDA submission.

Here's what can be extracted and inferred based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document states: "The subject devices were tested and met all respective acceptance criteria as specified per the individual test report." and "The acceptance criteria for the subject device were similar to the acceptance criteria for the Stryker predicate device." However, the specific acceptance criteria and detailed performance metrics are not provided in this summary.

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

The document primarily refers to "Bench" testing and "cadaver validation."

• Sample Size: Not specified for any particular test.
• Data Provenance: Implied to be in-house testing by Stryker Instruments, likely in the USA given the company's address. The testing is non-clinical.

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. The "tests" mentioned are physical/mechanical bench tests and cadaver validation, not diagnostic or clinical assessments requiring expert ground truth for interpretation.

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

Not applicable, as no expert-based ground truth establishment or adjudication is described.

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 study was not done. This device is a bone cement and a spinal system, not an AI-powered diagnostic tool. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." It does mention a "clinical literature review" to support safety and effectiveness of PMMA bone cement with augmentable pedicle screws, but this is a review of existing literature, not a new comparative effectiveness study.

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

Not applicable. This device is not an algorithm.

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

For the non-clinical bench testing, the "ground truth" would be the established engineering and materials science standards (e.g., ASTM F1798-12, ASTM F1717-12, ANSI/AAMI ST72:2011(R2016), ISO 11137-2:2013, ASTM F1980, ISO 11607) that define acceptable performance for device characteristics like static strength, pullout force, sterility assurance, endotoxin limits, and shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

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