(28 days)
The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Not Found
The provided text describes a medical device, the Solitaire™ Anterior Spinal System, and its regulatory submission. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested by the prompt (i.e., performance metrics, sample sizes, expert involvement, etc.).
Instead, it's a 510(k) premarket notification for a spinal system, which is primarily focused on demonstrating "substantial equivalence" to predicate devices based on technological characteristics and mechanical performance. The "Performance Testing" section states that "Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance." It then adds, "The design requirements were established based on those of the previously cleared predicate devices."
This indicates that the study involved mechanical testing, but the details of that testing, including specific acceptance criteria, reported performance, sample sizes, or any human-in-the-loop aspects, are not present in this document.
Therefore, I cannot populate the table and answer the specific questions as requested, as the necessary information is not available in the provided text.
Summary of missing information:
- No specific acceptance criteria metrics are listed.
- No reported device performance values are given.
- No sample sizes for test sets or training sets are mentioned.
- No data provenance details are provided.
- No information on experts (number, qualifications, adjudication) is present, as this was a mechanical test, not an image-based or diagnostic study.
- No MRMC comparative effectiveness study or standalone algorithm performance is discussed, as this is a physical medical device, not an AI/software device.
- No details on ground truth establishment are available.
§ 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.