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The EXPEDIUM and VIPER Spine Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM and VIPER Spine Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation 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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER Spine System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER Spine Systems are intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VIPER System (including VIPER2) is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The system is composed of components offered in a range of sizes to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors including screws, longitudinal members including rods and interconnection mechanisms including set screws. The system is compatible with transverse connectors, like the SFX cross connector from the EXPEDIUM Spine System. The system components are implanted using class I premarket notification exempt manual surgical instruments.

The purpose of this premarket notification is to add new screws. The VIPER PRIME screws with fenestrations are designed to facilitate a posterior percutaneous approach with minimally invasive surgery (MIS) instrumentation. The VIPER PRIME screws with fenestrations are intended for use with existing components of the VIPER System to generate a posterior construct to provide immobilization and stabilization of spinal segments. The VIPER PRIME screws with fenestrations are designed with a cannulation through the screw shank and lateral fenestrations and may be used in conjunction with, or without, CONFIDENCE™ High Viscosity Spinal Cement in accordance with the indications for use specified below.

This document is a 510(k) premarket notification for a medical device (VIPER PRIME™ Screws with Fenestrations), not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study performance, sample sizes, expert involvement, ground truth methods, or MRMC studies.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Indications for Use: Listing the intended clinical applications (e.g., spinal instability, trauma, tumors).
• Device Description: Detailing the components and their function.
• Technological Characteristics: Material (Titanium alloy), design (cannulated, fenestrated screws), and performance testing (mechanical testing, computational study, engineering analysis).

In summary, this document does not provide the information needed to answer your questions about acceptance criteria and study proving device performance for an AI/ML medical device.

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