(26 days)
The InterPlate™ GC VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.
The InterPlate™ GC VBR System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
The provided text describes a 510(k) premarket notification for a spinal intervertebral body fixation orthosis, the InterPlate™ GC VBR. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical study with specific acceptance criteria and performance data.
Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria, as it's not a de novo approval demonstrating novel performance.
Specifically, the following information cannot be extracted from the document:
- A table of acceptance criteria and the reported device performance: This type of data is not presented as the submission is for substantial equivalence.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as a test set with ground truth is not described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a medical implant, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document explicitly states: "Documentation was provided which demonstrated the InterPlate™ GC VBR to be substantially equivalent to the previously cleared InterPlate™ VBR. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the approval relies on a comparison to an existing device, not on new performance data against specific acceptance criteria.
§ 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.