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The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicle fixation 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 ULC 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 ULC spinal pedicle screw system is one touch single unitary locking cap, posterior spinal fixation system which consists of pedicle screws (monoaxial screw & poly-axial screw), rod and locking cap.

The ULC system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Components of the ULC system are supplied non-sterile and single use.

The ULC system is fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the ULC Spinal pedicle screw systems.

The provided text is a 510(k) Summary for the ULC spinal pedicle screw system. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way a clinical performance study would.

Instead, the document states: "Bench testing as listed in Section 14 and Appendix D. was conducted in accordance with ASTM F1717. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles."

This refers to mechanical and material testing, not a clinical study involving human or even animal subjects to assess performance metrics like sensitivity, specificity, or reader agreement. Therefore, most of the requested information regarding acceptance criteria and studies (like sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in the provided text.

Based on the provided text, here's what can be answered:

1. A table of acceptance criteria and the reported device performance:
   The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. It refers generally to "bench testing as listed in Section 14 and Appendix D... conducted in accordance with ASTM F1717." ASTM F1717 is a standard for in vitro static and fatigue testing of spinal implant constructs in a corpectomy model. The "reported device performance" would be the results of these mechanical tests demonstrating the device's ability to withstand certain static and fatigue loads, but these specific results are not included in this summary.

   Acceptance Criterion	Reported Device Performance
   Not specified for clinical performance or accuracy. However, the device met the requirements of ASTM F1717 for mechanical performance.	Specific results not provided in this summary. It states: "demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable. The document refers to "bench testing" (mechanical testing) not a clinical study with a test set of data/patients.

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, as this was not a clinical or diagnostic study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as this was not a clinical or diagnostic study.

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. The device is a spinal pedicle screw system, not an AI/imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. The device is a spinal pedicle screw system, not an AI/imaging diagnostic device. The "standalone" performance would refer to the mechanical performance of the physical implant itself in bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For mechanical testing (ASTM F1717), the "ground truth" would be the engineering specifications and performance limits defined by the standard.

8. The sample size for the training set:
   Not applicable. This is not a study involving machine learning or AI with a training set.

9. How the ground truth for the training set was established:
   Not applicable. This is not a study involving machine learning or AI with a training set.

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