(67 days)
The Spacevision™ Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of 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 in the thoracolumbar spine (T1-L5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.
The Spacevision cage implant is an oval shaped device with teeth on the upper and lower portions. The implant is hollow and can be used with bone graft when implanted. The implant is manufactured from PEEK Optima® LT1 and contains tantalum beads for location on radiographs. A variety of sizes are available, and the implants may be inserted individually or in pairs.
This document is a 510(k) summary for the "Spacevision™ Cage System," a medical device intended for vertebral body replacement. The key takeaway from this document is that the device's acceptance criteria and its demonstration of meeting these criteria are solely based on mechanical testing for substantial equivalence to previously cleared predicate devices.
Therefore, the following information regarding AI/algorithm performance, ground truth, expert opinions, and multi-reader studies is not applicable to this submission, as it predates and does not involve AI or diagnostic algorithms.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in mechanical properties to predicate devices for VBR. | Mechanical testing demonstrated equivalence of the construct design to currently marketed spinal systems. |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the Spacevision™ Cage System itself undergoing mechanical testing, not a dataset for an algorithm. The data provenance is mechanical test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a mechanical device is established through engineering and material science principles, typically evaluated by qualified engineers or test facilities. The document does not specify the number or qualifications of individuals who performed or reviewed the mechanical testing.
4. Adjudication method for the test set: Not applicable. Adjudication methods are relevant for subjective assessments or when reconciling differing expert opinions, which is not the case for mechanical testing of a medical device's physical properties.
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: Not applicable. This device is a physical implant, not an AI or diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an AI or diagnostic algorithm.
7. The type of ground truth used:
- Mechanical Testing Results: The "ground truth" for the device's performance is established by its ability to meet the defined mechanical performance specifications that demonstrate equivalence to predicate devices. This typically involves biomechanical tests to assess strength, fatigue, and stability.
8. The sample size for the training set: Not applicable. This device is a physical implant, not an AI or diagnostic algorithm, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established: Not applicable, for the same reason as above.
§ 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.