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The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text describes the Paramount™ VBR System, a device for vertebral body replacement, and its 510(k) clearance. However, it does not contain information about a study based on acceptance criteria for device performance with a specific output metric, such as those typically found in AI/ML device submissions. The performance data mentioned refers to mechanical testing according to general ASTM standards and biocompatibility.

Therefore, many of the requested items related to a study proving the device meets acceptance criteria cannot be answered from the provided text.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Device Performance:

Information Not Available in the Provided Text:

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

Explanation:

This document is a 510(k) summary for a traditional medical device (spinal implant), not an AI/ML-powered device. The "performance data" refers to standard engineering and biocompatibility tests to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics (like sensitivity, specificity, AUC) for an algorithm's output. Therefore, the details requested for AI/ML device studies (such as test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission and are not present in the provided text.

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