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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to 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); turnor: pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range/Mesa/Denali Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors The subject 510(k) adds Mesa 2 implants and connectors to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

The provided text is related to a 510(k) premarket notification for a spinal fixation system, not a device that would typically have acceptance criteria and performance evaluated through clinical studies with ground truth. This document is a regulatory clearance from the FDA for a medical device (Range/Denali/Mesa Spinal System) based on its substantial equivalence to previously marketed predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets cannot be extracted from this document. The document describes a "non-clinical performance evaluation" based on mechanical testing, not a study involving human data or AI algorithms.

Here's why and what information is available:

• Device Type: The device is a "Spinal Fixation System" (pedicle screws, rods, hooks, connectors) which is an implantable medical device used in orthopedic surgery. These devices are typically cleared based on mechanical performance, material compatibility, and substantial equivalence to existing devices, rather than human clinical studies with "ground truth" as you'd find for diagnostic AI algorithms.
• Regulatory Pathway: This is a 510(k) submission, which means the manufacturer is demonstrating that their new device is substantially equivalent to a legally marketed predicate device. This often relies on comparative analysis of design, materials, and mechanical testing, rather than extensive human clinical trials to establish efficacy or diagnostic performance.
• "Performance Evaluation" mentioned: The document states: "Performance evaluations were conducted on constructs representing the worst case components (including static torsion, static compression and dynamic compression bending in accordance with ASTM F1717) and the proposed implants were found to be substantially the same as predicate devices." This refers to mechanical testing in a lab setting, not a clinical study involving patients or AI.

In summary, there is no information in the provided text to fulfill your request for acceptance criteria and study details related to device performance in a clinical setting, as this document pertains to the regulatory clearance of a physical implantable device based on substantial equivalence and mechanical testing.

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