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The INNOVERSE Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

The INNOVERSE Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of variety pedicle screws, rods, set screws, connectors and cross link. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. Pedicle Screw is provided in Modular type (Tulip is provided in a separated state and assembled after screw insertion.) and pre-assembly type (Tulips are supplied assembled.). All pedicle screws have self-tapping function in INNOVERSE Spinal System. The tulip accommodates a 5.5 and 6.0 mm diameter rod in Ti Alloy and CoCr for increased construct rigidity. The INNOVERSE Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The INNOVERSE Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537).

The provided document is a 510(k) premarket notification summary for the INNOVERSE Spinal System. The device is a posterior, noncervical pedicle fixation system and is categorized as a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing clinical trial data for AI performance. Therefore, many of the requested criteria related to AI device evaluation (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this particular document.

Here's a breakdown of the information that can be extracted from the provided text, and where certain requested information is not available:

1. A table of acceptance criteria and the reported device performance

Note: The document states that the new device's performance is "substantially equivalent" to that of the predicate device for each test. Specific numerical thresholds or detailed results for individual tests are not provided in this summary but would be present in the full 510(k) submission.

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

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that would typically use data sets for performance evaluation in the way described. The "tests" here refer to mechanical engineering tests of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable for the same reasons as above. Ground truth, in the context of this device, would relate to the physical properties and performance of the hardware, which are evaluated through standardized mechanical testing methods, not expert consensus on data.

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

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device. Mechanical tests follow predefined protocols (e.g., ASTM standards) rather than requiring expert adjudication of results in the way clinical data might.

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. This is a submission for a spinal implant system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

This information is not applicable as this submission is for a mechanical spinal system, not an AI algorithm.

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

For this mechanical device, the "ground truth" or reference for evaluating its performance comes from established ASTM standards (ASTM F1717, ASTM F1798) and comparison to the predicate device's previously cleared performance.

8. The sample size for the training set

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that requires a training set.

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

This information is not applicable for the reasons stated above.

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