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The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EVEREST Spinal System is a top-loading, multiple component, posterior (thoracic/lumbar/sacral) spinal fixation system consisting of pedicle screws, hooks, rods and connectors.

This document describes a 510(k) premarket notification for the EVEREST Spinal System, which is a medical device for spinal fixation. It details the device's indications for use and states that the current 510(k) submission is specifically for adding a set screw to the existing system.

Based on the provided text, the specific information requested in the prompt regarding acceptance criteria and a study proving device performance (especially related to AI or a software-driven device) is not available. The document focuses on the regulatory clearance process for a physical medical device (spinal system components), not a software or AI-based diagnostic tool.

The "Performance Data" section explicitly states: "The modified device was evaluated via finite element analyses. The results demonstrated the performance of the modified set screw is substantially equivalent to the predicate." This indicates an engineering analysis rather than a clinical study with human data.

Therefore, I cannot fulfill the request to provide details about acceptance criteria, test set sample size, expert ground truth establishment, or multi-reader multi-case studies, as these concepts are not applicable to the information provided about the EVEREST Spinal System.

If your request pertains to a different document or scenario where AI/software performance is being evaluated, please provide that relevant text.

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