(119 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Test Performance (ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02) | "demonstrate that the Paramount™ VBR device can be expected to perform in a manner substantially equivalent to the predicate devices." |
| Biocompatibility | "Biocompatibility of the device was demonstrated." |
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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.