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The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, 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, kyphosis; 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 LS-S 1 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 degencration 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 fision.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) 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 provided document is a 510(k) premarket notification for the Range Spinal System: Mesa Modifications. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information typically requested regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment for AI/diagnostic devices will not be present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test Set Sample Size: Not applicable. The submission relies on mechanical testing of components, not human test subjects or clinical data in the context of diagnostic performance. The sample size for the mechanical tests (e.g., number of screws or rods tested) is not specified in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data provenance is from laboratory mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. Ground truth as typically understood for diagnostic or AI devices (e.g., expert consensus on medical images) is not relevant for this type of mechanical device submission and testing. The "ground truth" here is compliance with ASTM standards and comparison to a predicate device's mechanical properties.

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

• Not applicable. This is not a clinical study involving human readers or interpretation of results that would require an adjudication method.

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 is a spinal fixation system, not an AI or diagnostic device designed to assist human readers.

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

• Not applicable. This refers to an AI/algorithm's performance, which is not relevant to this device.

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

• The "ground truth" in this context is the established performance characteristics and mechanical properties of the legally marketed predicate devices, and the compliance with established ASTM standards (like F1717) for mechanical testing.

8. The sample size for the training set:

• Not applicable. This submission does not involve machine learning or AI models with training sets.

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

• Not applicable. There is no training set mentioned in this submission.

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