(29 days)
Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Fortitude Vue 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. Fortitude Vue is intended to be used with bone graft.
Fortitude Vue is a hollow device intended for use as a spinal intervertebral body fixation orthosis.
The provided text describes the Fortitude™ Vue Vertebral Body Replacement Device. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it states:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Data | Not explicitly stated as acceptance criteria, but implied to demonstrate substantial equivalence to the predicate device in design and performance. | "Laboratory and bench testing results demonstrate that the proposed Fortitude Vue is substantially equivalent to the predicate device." |
| Clinical Data | Not explicitly stated as part of acceptance criteria. The submission indicates clinical data were not needed, implying that substantial equivalence was sufficiently demonstrated through non-clinical means. | "Clinical data and conclusions were not needed for this device." (This implies it met the criteria for not needing clinical data, likely due to substantial equivalence to a previously cleared device). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. The document states, "Clinical data and conclusions were not needed for this device." The non-clinical testing results demonstrating substantial equivalence do not quantify a "test set" in the context of clinical or performance data from a specific number of devices.
- Data provenance: Not applicable for clinical data. For non-clinical (laboratory and bench testing), the provenance is not specified, but it would have been conducted as part of the manufacturer's development and testing processes.
3. 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 clinical data and a test set requiring expert ground truth were not part of the submission. The "ground truth" for substantial equivalence was based on engineering analysis and comparative mechanical testing to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical test set requiring adjudication was not used.
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 spinal implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for a clinical ground truth. The "ground truth" for the device's performance was its demonstrated equivalency in laboratory and bench testing against the predicate device, Fortitude™ Titanium (K031914).
8. The sample size for the training set
Not applicable, as there is no "training set" in the context of this device. The device is a physical implant, not an artificial intelligence model.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
§ 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.