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The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

The Arsenal Spinal Fixation System is a Class III non-cervical, posterior approach pedicle screw system. The Arsenal Spinal Fixation System allows surgeons to perform posterior thoracolumbar spine fusion utilizing both implants for fixation and ergonomic instruments to meet the surgeon's needs.

This traditional 510(k) submission adds a new pedicle screw system to Alphatec Spine's current offering and provides the following:

• Polyaxial, Reduction, Sacral, and Cortical non-cannulated, titanium, self-tapping, pedicle . screws
• Cancellous, Sacral, and Cortical dual lead threadforms ●
• Titanium set screws .
• Straight and pre-contoured rods in titanium and cobalt chromium .
• Titanium connectors which include Variable Bridges, Offset Connectors, Revision Connectors, Axial Connectors and Domino Connectors
• . Instrumentation necessary to perform posterior fixation system procedures
• . Connects with other Alphatec Spine systems to provide fixation for the entire spine

The Arsenal Spinal Fixation System is a mechanical device, and its performance is evaluated through non-clinical mechanical testing rather than studies involving human or animal subjects or complex AI algorithms. Therefore, many of the typical acceptance criteria and study details requested for an AI/ML medical device submission are not applicable here.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by statistical methods for component and system-level tests and depend on the variability of the material and design, aiming to demonstrate reliability and robustness.
• Data Provenance: Not applicable in the context of typical clinical data provenance (such as country of origin, retrospective/prospective). This refers to non-clinical laboratory testing performed to established ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for mechanical device testing is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for mechanical properties and performance. These standards define the test methods and what constitutes acceptable performance for spinal fixation systems.

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

• Not applicable. This concept pertains to methods used to resolve disagreements among human reviewers of clinical data. For mechanical testing, results are quantitative and objective, measured by laboratory equipment against defined pass/fail criteria within the ASTM standards.

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 purely mechanical device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. There is no algorithm or AI component in this device.

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

• The "ground truth" for this device's performance is defined by the established benchmarks and criteria within specific ASTM International standards (e.g., ASTM F1717, ASTM F1798) for spinal implant mechanical performance. These standards are developed through a consensus process by experts in the field.

8. The sample size for the training set:

• Not applicable. This is a physical medical device undergoing mechanical testing, not an AI/ML algorithm requiring a training set.

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

• Not applicable, as there is no training set for this type of device.

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