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The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are 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 bon 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 4CIS® SOLAR Spine System and 4CIS® APOLLON 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, spinal tumor and failed previous fusion (pseudarthrosis).

The 4C15® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-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 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System.

The provided text describes a medical device, the "4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System," which is a pedicle screw spinal fixation system. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or a study that specifically addresses these points as typically expected for software or AI-based devices.

The core of the document is a 510(k) summary for a spinal implant system, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not involve AI or software performance metrics that would require the detailed study information you've requested.

Therefore, I cannot populate the requested sections because the information is not present in the provided text. The document discusses:

• Device Identification: Trade name, common name, classification.
• Substantially Equivalent Predicate Devices: Identification of similar devices already on the market.
• Device Description: What the device is made of and its components.
• Indications for Use: What the device is intended to treat and where it can be used in the spine.
• Performance Data and Test Method: This section explicitly states: "Mechanical testing has been carried out as listed in APPENDIX 10 which includes the static compression test and static torsion test as well as the dynamic compressive fatigue testing in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." This refers to physical, mechanical tests of the implant's strength and durability, not performance criteria for a diagnostic/AI tool.

The question's structure (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, standalone performance, training set) is typically relevant for evaluating AI/machine learning algorithms or diagnostic devices. Since this document describes a physical surgical implant, these types of details are not applicable as presented.

In conclusion, the input text does not contain the information requested regarding the acceptance criteria and the study that proves the device meets those criteria, as understood in the context of device performance metrics for AI/software/diagnostic tools.

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