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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; 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 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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Mesa Spinal System is a top-loading, multiple component, spinal fixation system. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from titanium and cobalt chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.

The provided text pertains to a 510(k) summary for the "Mesa Spinal System" and its substantial equivalence to predicate devices. It describes the device, its intended use, and a comparison to other legally marketed systems, primarily focusing on mechanical testing against ASTM F1717 standards.

However, the document does not contain information about acceptance criteria, a specific study used to prove the device meets those criteria, or details regarding ground truth, expert consensus, or clinical performance data that would typically be found in a study demonstrating effectiveness for a diagnostic or AI-driven device.

This document is for a spinal fixation system, which is a mechanical implant, not a diagnostic or AI device. Therefore, the questions posed (related to AI performance, expert ground truth, multi-reader studies, etc.) are not applicable to this type of medical device submission.

The "study" referenced in the document is mechanical testing to ASTM F1717.

Here's how to address the prompt based on the provided text, while acknowledging the limitations:

1. A table of acceptance criteria and the 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 specified in terms of patient data. The "test set" here refers to the components of the Mesa Spinal System subjected to mechanical testing. The number of components tested for ASTM F1717 is not detailed.
• Data Provenance: Not applicable in the context of patient data for a mechanical fixation device. The testing is performance-based for the device itself.

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. This document describes a mechanical device, not a diagnostic or AI system requiring expert-established ground truth from medical images or clinical outcomes. The "ground truth" for the mechanical testing is defined by the ASTM F1717 standard itself.

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

• Not applicable. Adjudication methods are typically used for clinical studies involving human interpretation or uncertain outcomes. This document details mechanical testing 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

• No. This is a mechanical spinal fixation system, not a diagnostic or AI device. An MRMC study is not relevant to this type of device.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• The "ground truth" in this context is the ASTM F1717 standard for mechanical testing of spinal implant constructs. The device's performance is compared against the requirements and performance characteristics of legally marketed predicate devices as measured under this standard.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI system that requires a "training set."

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

• Not applicable. As a mechanical device, a training set and its associated ground truth are not relevant concepts for this submission.

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