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The EXPEDIUM and VIPER 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 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER 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.

The proposed closed polyaxial screws for EXPEDIUM and VIPER Spine System are available in various geometries and sizes. Manufactured from ASTM F138 implant grade stainless steel and ASTM F136 implant grade titanium alloy.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

This submission focuses on non-clinical (mechanical) testing for "EXPEDIUM® and VIPER® Systems" for spinal fixation. There were no clinical studies performed in this submission.

2. Sample size used for the test set and data provenance:

The document does not explicitly state the sample sizes for each mechanical test. However, these tests are typically conducted on multiple samples of the device components to ensure consistency and reliability. The data provenance is from non-clinical laboratory testing conducted by the manufacturer, DePuy Spine, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for mechanical testing is established by engineering standards (ASTM F 1798-97) and measured physical properties, not by human expert interpretation.

4. Adjudication method for the test set:

Not applicable. Mechanical tests involve objective measurements against predefined engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This was a non-clinical submission for spinal implants, focusing on mechanical performance. MRMC studies are relevant for evaluating diagnostic or interpretive devices that involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is a hardware device (spinal implants), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The performance evaluated here is the standalone mechanical integrity of the device itself.

7. The type of ground truth used:

The ground truth used was objective mechanical measurements against established ASTM standards (ASTM F 1798-97) for spinal arthrodesis implants.

8. The sample size for the training set:

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as no training set was used.

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