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The BASE Interfixated Titanium System is indicated for spinal fusion procedures in sketally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The BASE Interfixated Titanium System is interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The BASE Interfixated Titanium System implants can adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the BASE Interfixated Titanium System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The NuVasive BASE Interfixated Titanium System is an interfixated interbody system manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive BASE Interfixated Titanium System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The BASE Interfixated Titanium System consists of a titanium alloy interbody and three (3) titanium alloy bone screws. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The provided document is a 510(k) premarket notification for the NuVasive® BASE Interfixated Titanium System, an intervertebral body fusion device.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for the nonclinical tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The tests are described as in vitro nonclinical studies, not human clinical trials.

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 information is not applicable. The device is an intervertebral body fusion system, and its performance was evaluated through nonclinical mechanical testing, not by expert assessment of images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable, as the performance evaluation was based on mechanical testing outcomes rather than expert adjudication.

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:

This information is not applicable. The device is a surgical implant (intervertebral body fusion device), not an AI-powered diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable, as the device is a physical surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the nonclinical tests was established by conformance to recognized ASTM standards (ASTM F2077, ASTM Work Item Z8423Z) and comparison to the performance of a legally marketed predicate device. This essentially means the performance established by these standardized mechanical tests serves as the objective measure for equivalence.

8. The sample size for the training set:

This information is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as above; there is no training set for a physical medical device.

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