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RANGE /DENALI, MESA and SMALL STATURE and ARI 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. scollosis, 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 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, in skeletally mature patients, 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.c. fracture or dislocation); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous 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. Pediatric pediatric pediale screw fixation is limited to a posterior approach.

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, connectors, 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 purpose of this submission is to add titanium bilateral contoured unit rods to the system.

The provided text describes a 510(k) summary for the Range Spinal System, a medical device for spinal fixation. It aims to demonstrate substantial equivalence to predicate devices, focusing on the addition of titanium bilateral contoured unit rods.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of clinical data. The performance comparison refers to mechanical testing of implants. There's no mention of human subject data, and therefore no provenance information (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the summary focuses on mechanical and design equivalence, not clinical performance requiring expert ground truth or assessment of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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 information is not applicable. This submission is for a spinal fixation system, a physical implant, not an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device appears to be:

• Predicate Device Performance: The established performance and safety of the previously cleared K2M Range Spinal System and Synthes USS, Click'X, VAS. Dual -Opening, Small Stature (K022949).
• ASTM F1717 Standards: These provide the engineering standards for testing spinal fixation devices, against which the modified implants were evaluated.
• Engineering Rationale: An engineering assessment determining that the changes do not introduce a "new worst case."

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical device testing or clinical data for an implant.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Study That Proves the Device Meets the Acceptance Criteria:

The study that proves the device meets the acceptance criteria is an engineering and mechanical testing comparison study.

• Methodology: The "modified implants were compared to constructs previously tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717."
• Conclusion: Based on this comparison, an "engineering rationale determined that the proposed implants do not represent a new worst case" and were "therefore determined to be substantially equivalent to the predicate devices."

In essence, the study was a benchtop mechanical performance evaluation demonstrating that the updated components of the Range Spinal System (specifically the bilateral contoured unit rods) meet the established mechanical performance standards and do not introduce new risks compared to the previously cleared predicate devices. The acceptance criteria were met by showing equivalence in mechanical properties to previously cleared devices under standardized test conditions.

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