(155 days)
The NuVasive® Lateral VBR System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
The NuVasive Lateral VBR System is a vertebral body replacement device manufactured from carbon-fiber PEEK (polyetheretone) and titanium alloy conforming to industry recognized standards that is available in a variety sizes to suit the individual pathology and anatomical conditions of the patient. The Lateral VBR System vertebral body replacement device is designed to address thoracolumbar pathologies utilizing implant placement though a lateral approach. This implant inserter is specifically designed to place and expand the implant device. Allograft or autograft material may be used to facilitate fusion. The subject device components are manufactured from Carbon-Fiber Reinforced PEEK-Optima® LT1CA30 (CFRP) and titanium alloy conforming to ASTM F136 and ISO 5832-3.
The provided document is a 510(k) premarket notification for a medical device (NuVasive® Lateral VBR System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial or a more comprehensive validation study for a novel device.
Consequently, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document. The document explicitly states: "No non-clinical or clinical studies were conducted."
However, I can extract the available information regarding performance data and the conclusion drawn from it.
1. A table of acceptance criteria and the reported device performance
Based on the document, "acceptance criteria" are not explicitly defined in a quantitative table with specific thresholds. Instead, the performance evaluations were conducted to demonstrate substantial equivalence to predicate devices. The reported "performance" is a qualitative conclusion based on meeting these equivalence criteria.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Demonstrate equivalence to predicate devices for mechanical properties, presenting no new worst-case. | Static and dynamic axial compression, compression shear, and torsion (per ASTM F2077): The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing. |
| Wear debris testing (per ASTM F1714 and ASTM F1877): The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing. | ||
| Expulsion testing: The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing. | ||
| Cadaver testing: The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing. |
Study that proves the device meets the acceptance criteria:
The document states: "Nonclinical testing was performed to demonstrate that the subject Lateral VBR System is substantially equivalent to other predicate devices." The listed tests were:
- Static and dynamic axial compression, compression shear, and torsion per ASTM F2077
- Wear debris testing per ASTM F1714 and ASTM F1877
- Expulsion testing
- Cadaver testing
The conclusion from these tests was: "The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate."
2. Sample sized 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 specified. The document refers to "nonclinical testing" and does not detail the number of units tested.
- Data provenance: Not specified. These were likely laboratory tests rather than human subject data.
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/Not specified. "Ground truth" in the context of device performance testing generally refers to objective measurements and adherence to standard specifications, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical endpoints, which were not part of this "nonclinical testing" as described.
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
- No. The document explicitly states: "No non-clinical or clinical studies were conducted." This device is a physical implant, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This question is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- "Ground truth" was based on objective measurements from engineering and simulated use testing (e.g., mechanical properties, wear debris, expulsion resistance) in accordance with recognized ASTM and ISO standards. The "truth" implies that the device met the specified performance characteristics without presenting a "new worst-case" compared to predicate devices.
8. The sample size for the training set
- Not applicable/Not specified. This is a physical device, and the concept of "training set" is generally for machine learning algorithms or for extensive R&D iterations which aren't detailed here. The documentation focuses on verification testing against established standards.
9. How the ground truth for the training set was established
- Not applicable. There was no "training set" in the context of this device's validation as presented in the document.
§ 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.