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The EXPEDIUM and VIPER/VIPER2 Spine Systems are intended to provide immobilization and stabilization 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/VIPER2 Spine System metallic components 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/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for 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, 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/VIPER2 System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 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/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI-SI in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated 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. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject EXPEDIUM® Spine System and VIPER®/VIPER®2 Systems are pedicle screw scoliosis systems for the treatment of pediatric patients consisting of a wide range of components in a variety of geometries and sizes.

The provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or algorithmic performance.

Instead, this is a 510(k) summary for the "EXPEDIUM® Spine System, VIPER® System, VIPER®2 System," which are pedicle screw spinal systems. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, an approval pathway primarily concerned with the safety and effectiveness of a new device compared to an existing one, rather than novel performance benchmarks.

Here's a breakdown of what the document does state regarding performance:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document does not define specific performance metrics or acceptance criteria for the device's function or a study comparing it to those criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance for performance evaluation is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.

4. Adjudication method for the test set: Not applicable. No test set adjudication is described.

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 device is a surgical implant (pedicle screw system), not an AI-assisted diagnostic tool, so an MRMC study is irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic or AI device.

7. The type of ground truth used: Not applicable. No ground truth is mentioned.

8. The sample size for the training set: Not applicable. No training set is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set ground truth is mentioned.

Key statements from the document regarding performance:

• "No new testing was performed. Published clinical results and engineering analysis supported the expansion of indications." (Page 2, section "Performance Data")
• "The substantial equivalence justification demonstrates that the device is as effective, and performs as well as the predicate device." (Page 3, Conclusion)

In summary, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, drawing on existing clinical results and engineering analyses, rather than presenting a performance study with defined acceptance criteria for the device itself.

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