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The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:

• Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fractures or dislocations)
• Spinal Stenosis
• Curvatures (i.e. scoliosis, kyphosis and/ or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS system is indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The MOSS VRS system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions. The MOSS VRS System is a universal set of instruments and implants that are indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation.

The MOSS VRS System provides several options for stabilization of the spine. Therefore, the system includes the following implants:

• Pedicle Screws Ø4.35-9mm, length 20-100mm
• Rods Ø5,5mm and Ø6,0mm, length 30-95mm, 120-600mm
• Locking Caps
• Polyaxial Reductionheads

The implants of the MOSS VRS System are single-use only and the system is provided non sterile.

This appears to be a 510(k) Summary for a medical device (MOSS VRS Spinal System). The document describes the device, its indications for use, and a comparison to predicate devices, including performance data. However, it does not describe a study involving an AI/Machine Learning device or specific acceptance criteria for such a device in the way your prompt requests.

The performance data section (8.1 Non-Clinical Test Summary) details bench testing for mechanical properties of the physical spinal implant system. It explicitly states, "No clinical tests were performed" (8.2 Clinical Test Summary).

Therefore, I cannot provide the requested information for an AI/ML device because this submission focuses on a traditional medical device (a spinal implant system) and its mechanical performance, not an AI-powered diagnostic or therapeutic tool.

If this document were for an AI/ML device, the requested information would typically be found in dedicated sections outlining the algorithm's performance study.

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