(125 days)
The NuVasive Sage Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Sage Lateral Plate System includes plates, screws, and spikes manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The NuVasive Sage Lateral Plate System is a medical device. The provided text describes the 510(k) summary for this device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria or through a standalone clinical study.
Here's an analysis based on your request, highlighting what information is and is not available in the provided text:
Based on the provided 510(k) summary, the device is a spinal implant system and the "study" conducted is a nonclinical performance testing to demonstrate substantial equivalence to predicate devices. There is no information about a clinical study with human subjects, acceptance criteria related to a specific performance metric (like accuracy, sensitivity, specificity, etc.), or expert ground truthing as would be typical for an AI/algorithm-based device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Nonclinical) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices based on nonclinical testing. | The Sage Lateral Plate System was shown to be substantially equivalent to its predicate devices through comparison of design, intended use, material composition, and function. |
| Static and dynamic compression testing per ASTM F1717 meets predicate performance. | Results "demonstrate that the subject Sage Lateral Plate System presents no new worst-case for performance testing" compared to the predicate device, implying it met or exceeded the performance of the predicate in these tests. |
| Static torsion testing per ASTM F1717 meets predicate performance. | Results "demonstrate that the subject Sage Lateral Plate System presents no new worst-case for performance testing" compared to the predicate device, implying it met or exceeded the performance of the predicate in these tests. |
Note: The acceptance criteria here are focused on mechanical performance and equivalence, not clinical performance metrics for an AI/software 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: Not applicable in the context of a "test set" for an AI/algorithm. The "testing" refers to mechanical and material tests of the physical implants. The number of samples/units tested is not specified, but it would involve a certain number of implant components (plates, screws, spikes) to conduct the ASTM F1717 tests.
- Data Provenance: Not applicable. The "data" comes from engineering and material testing in a lab setting, not from patient data or clinical studies.
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)
- This is not applicable as the ground truth here is based on engineering and material standards (ASTM F1717) and mechanical testing results, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as there is no human interpretation or adjudication involved in establishing ground truth for mechanical testing.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/software devices that aid in interpretation or diagnosis, which is not the function of a spinal implant system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone study was not done. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device, in the context of a 510(k) submission for a physical implant, is based on established engineering standards and mechanical test results (e.g., strength, durability, fatigue resistance as defined by ASTM F1717). The comparison is against predicate devices that have already been cleared, implying their safety and effectiveness have been established through a similar process or prior clinical use.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this physical implant device.
In summary: The provided document is a 510(k) summary for a physical medical implant (spinal plate system). It demonstrates substantial equivalence to predicate devices through nonclinical mechanical testing. The concepts of "acceptance criteria," "test set," "ground truth," "experts," "adjudication," and "training set" as you typically define them for AI/software devices are not relevant or described in this context. The study outlined is a set of engineering performance tests to ensure the new device is as safe and effective as similar, already-approved devices.
§ 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.