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The TiLock2 Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Genesys Spine TiLock- Spinal System will be offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.

The provided text is a 510(k) summary for the Genesys Spine TiLock2 Spinal System. It does not contain information about acceptance criteria for device performance, nor does it describe studies that prove the device meets specific performance acceptance criteria in the context of an AI/ML device.

Instead, this document focuses on the mechanical performance testing of a spinal fixation system, comparing it to predicate devices to establish substantial equivalence for FDA clearance. The summary states:

"The predetermined pass/fail criterion was that the mechanical tests for the Genesys Spine TiLock Spinal System be equivalent to (or greater than) previously cleared spinal systems."

This indicates the acceptance criterion for the mechanical tests was that the TiLock2 system performed no worse than the predicate devices. The study involved analyzing the construct in accordance with ASTM F1717-04 and F1798.

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance acceptance criteria and studies within the provided text. The document describes a mechanical performance study comparing the new device to existing predicate devices.

However, I can extract the information that is present about the mechanical performance study:

1. A table of acceptance criteria and the reported device performance
No specific numerical acceptance criteria or reported performance values are provided for the TiLock2 Spinal System. The criterion is qualitative: "equivalent to (or greater than) previously cleared spinal systems."

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 states constructs were "analyzed," and mechanical tests were "performed on the worst case TiLock Spinal System constructs." However, it does not specify the sample size (number of constructs tested) or the data provenance (country of origin, retrospective/prospective). This is typical for mechanical testing documentation, which often focuses on test methods and results rather than data provenance in the same way clinical studies do.

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. This was a mechanical performance study, not a study involving human interpretation or ground truth establishment by experts in the context of an AI/ML device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing would be the measured physical properties and performance characteristics as defined by the ASTM standards.

8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device study.

9. How the ground truth for the training set was established
Not applicable.

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