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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;

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ): spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.

The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

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

The purpose of this 510(k) submission is to add minimally invasive implants.

Here's an analysis of the provided text regarding the Everest Spinal System, focusing on acceptance criteria and the study proving device performance:

Summary of Acceptance Criteria and Device Performance for the Everest Spinal System

It's important to note that the provided document is a 510(k) summary for a spinal fixation system, and not a diagnostic AI device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards mechanical and design equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI-powered diagnostic tools.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

Given this is a mechanical testing and design comparison, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as understood for AI/diagnostic studies is not directly applicable.

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It would typically involve a certain number of devices or components tested according to ASTM F1717.
• Data Provenance: Not applicable in the context of mechanical testing. The testing would be conducted in a laboratory environment following standardized procedures.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This category is not applicable for the Everest Spinal System 510(k) summary. "Ground truth" in this context refers to an objective standard, which for mechanical performance is established by the ASTM F1717 standard itself and the measured physical properties of the tested devices, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in diagnostic studies. Here, the "truth" is determined by direct mechanical measurements against a standard.

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. This device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies for human reader performance with or without AI assistance are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The Everest Spinal System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Mechanical Measurement Results: Directly measured values from static compression, static torsion, and dynamic compression tests performed according to ASTM F1717.
• Predicate Device Performance: The accepted performance characteristics of the legally marketed predicate devices (K2M Everest Spinal System, K2M Range Spinal System, NuVasive SpherX, Globus Resolve). The new device's performance is compared against these established benchmarks.
• Design and Sizing Equivalence: Direct comparison of the physical design and dimensions of the new components to those of the predicate devices.
• Material Standards: Compliance with ASTM and ISO standards for Titanium Alloy and Cobalt Chrome.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device undergoing mechanical testing and design comparison, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device submission.

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