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The VK100® Percutaneous Vertebral Augmentation System is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).

Like the predicate devices. VK100® is provided as a two-component system with barium sulfate as a radiopacifier. VK100® is a polydimethylsiloxane material. The VK100® System consists of a cartridge containing the two VK100® material components and a dispensing system which blends the two components for injection into the injured vertebrae. The material cures in situ to form a non-resorbable polymer.

The VK100® material is supplied in a pre-filled cartridge:

The 2-cylinder cartridge keeps each component separate until administration, when both components are extruded through a mix element, which blends the mixture at a 1:1 ratio.

Each dose (cartridge of VK100® material) consists of:

• Reinforced Dimethyl Methylvinyl Siloxanes ●
• . Barium Sulfate powder
• Methylhydrogensiloxane Crosslinker
• . Platinum catalyst,

The provided text describes a medical device, the VK100® Percutaneous Vertebral Augmentation System, and its submission for FDA clearance. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically designed to prove all acceptance criteria.

However, based on the provided text, we can extract details related to safety and performance, particularly concerning extravasation.

Here is an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" for the VK100® in the conventional sense (e.g., "extravasation rate must be less than X%"). Instead, it compares the VK100®'s performance to predicate devices, implying that acceptable performance is at least equivalent to or better than currently marketed devices.

Therefore, the "acceptance criterion" derived from the clinical study section is an implied comparison to the extravasation rates of predicate PMMA cements.

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

• Sample Size for Test Set: 124 subjects
• Data Provenance: The study population included a "consecutive series of 124 subjects." The text does not explicitly state the country of origin or if it was retrospective or prospective. Given the description, it likely refers to a retrospective review of existing clinical data, described as a "radiographic evaluation of existing clinical data."

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

• Number of Experts: An "independent review" was performed, implying at least one expert, but the exact number is not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The text only mentions an "independent review" of radiographic images.

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

• MRMC Comparative Effectiveness Study: No. The device described, VK100®, is a percutaneous vertebral augmentation system (bone cement), not an AI diagnostic tool. Therefore, an MRMC study related to human reading with or without AI assistance is not applicable.

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

• Standalone Performance Study: Not applicable. The VK100® is a medical device (bone cement), not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was based on radiographic evaluation by an independent reviewer(s) to identify extravasation and migration of the VK100® material. The "primary safety measure" was the "incidence or lack thereof of pulmonary emboli," which would be clinical outcomes data, but the evaluation itself was image-based.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The VK100® is a physical medical device, not an AI model that requires a training set. The clinical study described is a performance evaluation of the device in human subjects.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device type.

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