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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); 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 pediatic 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) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds sterile packaged implants to the system.

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

This document describes a 510(k) premarket notification for the EVEREST Spinal System. Based on the provided text, the device is a spinal fixation system, and the submission is for adding sterile-packaged implants to the system. The acceptance criteria and supporting study details are primarily related to mechanical performance and material compatibility, not a diagnostic or AI-driven device.

Here's an analysis of the provided information:

Assessment of Acceptance Criteria and Proving Study:

The document describes pre-clinical performance evaluations, not clinical studies in the context of an AI/diagnostic device. The "acceptance criteria" and "study" are focused on the mechanical and material aspects of the spinal implant.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for the mechanical and material tests performed according to recognized standards (ASTM F1717, AAMI/ANSI/ISO 11607). For mechanical testing of medical devices, sample sizes are typically determined by statistical methods or industry standards to ensure sufficient power to detect differences or confirm compliance.
• Data Provenance: The tests are non-clinical performance evaluations (i.e., laboratory testing). Therefore, there is no "country of origin of the data" or "retrospective/prospective" in the sense of patient data. The provenance is the results of laboratory tests conducted by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is relevant for diagnostic devices (especially those involving image interpretation or clinical assessment). For a spinal implant, "ground truth" relates to material properties and mechanical performance, which are evaluated through standardized physical testing, not expert interpretation of clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to resolve discrepancies among multiple expert readers. For mechanical testing, the results are quantitative measurements against predefined standards.

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:

This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation, particularly when evaluating the impact of AI assistance on reader performance. The EVEREST Spinal System is a physical implant, not a diagnostic or AI-assisted device.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The EVEREST Spinal System is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance evaluation is based on established engineering and material science standards and specifications. For example:

• Mechanical Strength: The "ground truth" is passing the load and fatigue requirements specified in ASTM F1717 (e.g., maintaining structural integrity and specific mechanical properties under defined static and dynamic loads).
• Biocompatibility/Material Safety: The "ground truth" is meeting the bacterial endotoxin limits and aging requirements as per relevant ISO standards (e.g., AAMI/ANSI/ISO 11607 for packaging and sterility).

8. The sample size for the training set:

This is not applicable. The device is not an AI/machine learning device, so there is no training set in this context.

9. How the ground truth for the training set was established:

This is not applicable. As there is no training set (being a physical medical device), the concept of establishing ground truth for it does not apply.

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