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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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic 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 posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, bridges and connectors to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

The purpose of this Traditional 510(k) Premarket Notification is to add deformity implants to the currently marketed Arsenal Spinal Fixation System and expand the current pediatric indication of the Arsenal System to include treatment of progressive spinal deformities.

The provided text is a 510(k) premarket notification summary for the Alphatec Spine, Arsenal Spinal Fixation System. This document is a regulatory filing for a medical device and does not describe the acceptance criteria or a study proving the device meets performance claims related to diagnostic accuracy or clinical outcomes.

Instead, it focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that FDA has already approved. The "performance data" mentioned refers to mechanical and engineering tests, not clinical studies in the typical sense of evaluating diagnostic performance or clinical improvement in patients.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies. The document simply does not contain this type of information.

The only "performance data" mentioned is:

• ASTM F1717 Static Compression Bending Test
• Dynamic Compression Bending Test
• Static Torsion Tests
• ASTM F1798 Static Flexion-Extension Moment (My) and Axial Gripping Capacity (FX)
• Axial & Maximum Angle Screw Body Pulloff Testing

These are biomechanical tests to assess the physical properties and strength of the spinal fixation system components. The "acceptance criteria" for these tests would typically be compliance with the standards (e.g., passing limits defined in the ASTM standards), but the specific numerical criteria and results are not provided in this summary.

In summary, the provided document does not contain the information required to populate the requested table and details about a study demonstrating device performance in a clinical or diagnostic context.

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