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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 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 pediale 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.

K2M Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems consisting of pedicle screws, rods, hooks and rod connectors. The subject 510(k) offers patient specific rods.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The provided document is a 510(k) summary for the K2M Patient Specific Rods, which are part of the EVEREST Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, materials, sizes, and mechanical testing, rather than clinical performance or AI/software validation. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, expert involvement, or ground truth related to AI/software.

The document states:

• Non-clinical Performance Evaluation: "Mechanical testing was performed in accordance with ASTM F1717 (including static torsion, static compression, and dynamic compression bending) and the results were comparable to previously cleared devices."

This indicates that the acceptance criteria for this device are likely related to mechanical properties as defined by the ASTM F1717 standard, and the study showing it meets these criteria is the mechanical testing itself, with "comparable" results to predicates meaning it met those mechanical performance benchmarks.

However, the specific numerical acceptance criteria, the reported device performance, and details like sample size for these mechanical tests are not provided in this summary. Furthermore, all other points in your request (related to test sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets/ground truth for AI) are not applicable as this document pertains to a physical medical device (spinal rods) and its mechanical performance, not a digital health product or AI algorithm.

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