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The Xing™ Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Xing™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Xing™ Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a cross link linking mechanism. The Xing™ Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Xing™ System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the Xing™ Spine System.

The provided text is a 510(k) Summary for the Xing™ Spine System. This document focuses on demonstrating substantial equivalence to predicate devices for a spinal implant (pedicle screw system), not an AI/ML-driven medical device for diagnosis or prognosis. As such, most of the requested information regarding AI/ML device performance criteria, studies, ground truth establishment, expert adjudication, and associated sample sizes is not applicable to this type of medical device submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance standards for spinal implants and the bench testing conducted to demonstrate conformance.

Here's the relevant information extrapolated from the document:

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

Notes:

• The document explicitly states: "Mechanical testing as listed in APPENDIX 3 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." This implies that the device successfully met the performance requirements/benchmarks established by this standard and shown by the predicate devices.
• The document doesn't provide specific numerical results (e.g., maximum load, cycles to failure) from these tests in the summary provided. It only states that the tests were conducted and demonstrate equivalence.

The following questions are not applicable to this 510(k) submission as it pertains to a mechanical spinal implant, not an AI/ML device:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

For mechanical devices like the Xing™ Spine System, performance is typically demonstrated through bench testing against recognized industry standards (like ASTM F1717) and comparison to legally marketed predicate devices, rather than clinical studies with patients or expert panel reviews of data. The "ground truth" for such devices is conformance to engineering specifications and mechanical properties.

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