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The EXPEDIUM Spine System and VIPER and VIPER 2 Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System and VIPER 2 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, 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 and VIPER 2 Systems are intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; 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 Spine System and VIPER and VIPER 2 Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System and VIPER 2 Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM and VIPER/VIPER 2 Spine Systems are metallic implants intended to provide immobilization and stabilization of spinal segments. They can be used for 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; or for posterior non-cervical pedicle screw fixation in pediatric patients as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft.

The EXPEDIUM Spine System consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers. The VIPER and VIPER 2 Systems consist of cannulated polyaxial screws, monoaxial screws, uni-planar screws, reduction screws, and rods used in a percutaneous approach.

This document is a 510(k) premarket notification for spinal systems (EXPEDIUM Spine System, VIPER and VIPER 2 Systems) and primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics, materials, and intended use. It does not contain information about the performance or acceptance criteria of a new device or software algorithm, nor does it describe a study proving such a device meets acceptance criteria.

The document discusses:

• Device Description: Spinal systems consisting of metallic implants (rods, screws, connectors) intended for immobilization and stabilization of spinal segments.
• Indications for Use: Treatment of chronic instabilities, deformities, degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients, and adolescent idiopathic scoliosis in pediatric patients.
• Materials: Commercially pure titanium, titanium alloy, stainless steel, cobalt-nickel-chromium-molybdenum alloy, and cobalt-chromium-molybdenum alloy.
• Performance Data: References only mechanical testing (ASTM F1717) and optical/visual analysis for corrosion compatibility of materials, stating that these materials are compatible even in aggressive environments for the duration expected for spinal fusion.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, device performance, study design (sample size, data provenance, expert review, adjudication, MRMC, standalone performance), or ground truth establishment for an AI/software device.

The document's "Performance Data" section specifically addresses the compatibility of the materials used in the predicate and subject devices, not the performance of a digital health or AI/ML-enabled device. It confirms material compatibility through mechanical testing and corrosion analysis, which is typical for implantable medical devices, but not for software or AI performance related to diagnostic or evaluative tasks.

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