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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, 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 pediation 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) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds rod-to-rod connectors to the system.

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

Based on the provided text, the "EVEREST Spinal System" is a medical device, and the document describes its FDA 510(k) clearance. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical device meets specific performance acceptance criteria through the kind of clinical study typically associated with AI/software-as-a-medical-device (SaMD).

Therefore, the information required to populate a table of acceptance criteria and a detailed study proving the device meets those criteria (especially related to AI/algorithm performance) is not present in this document.

This document focuses on:

• Substantial Equivalence: The FDA has determined the EVEREST Spinal System is substantially equivalent to predicate devices. This means it has similar indications for use, technological characteristics, and performs similarly in terms of safety and effectiveness as the predicate devices already on the market.
• Device Description: It's a spinal fixation system (pedicle screws, rods, hooks, rod connectors).
• Indications for Use: What conditions it's intended to treat (e.g., degenerative disc disease, scoliosis, trauma).
• Technological Comparison: The proposed implants are substantially "the same" as predicate systems in terms of design, materials, and sizes.
• Non-clinical Performance Evaluation: Mechanical testing was performed (e.g., static torsion, static compression, dynamic compression bending) in accordance with ASTM F1717, and the results were "comparable" to previously cleared devices.

There is no mention of an algorithm, AI, or any software component that would require an AI/SaMD specific study with ground truth establishment, expert adjudication, or MRMC studies. The "device performance" here refers to its mechanical capabilities as a physical implant, not diagnostic or therapeutic performance derived from an AI.

Given this, I cannot provide the requested information about acceptance criteria for an AI/algorithm and a study proving it meets those criteria because the provided text describes a physical medical device (spinal system) and its mechanical testing, not a digital health product with AI.

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