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The 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 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 PEEK rods of EXPEDIUM Spine System and VIPER Systems are contraindicated for degenerative disc disease.

The subject VIPER2 Spine System components consist of 5.5mm screws and rods and are available in various geometries and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VIPER™ 2 System:

It's important to note that the provided documents (K090648 Special 510(k) Submission) are for a spinal implant system (VIPER™ 2 System), which is a physical device, not an AI/software medical device. Therefore, many of the typical acceptance criteria and study types requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, ground truth for training set) are not applicable to this type of traditional medical device submission.

The "acceptance criteria" for a physical implant like this primarily revolve around mechanical performance and biocompatibility, demonstrating that the device is safe and effective for its intended use, and substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The key study mentioned is:

• Performance data per ASTM F 1717: This is an in vitro mechanical test standard for spinal implant constructions in a vertebrectomy model. This standard is used to evaluate the fatigue life and static strength of spinal instrumentation systems.

Explanation of the Study and its Relevance to Acceptance:

The submission explicitly states that "Performance data per ASTM F 1717 were submitted to characterize the subject VIPER2 System components addressed in this notification." This means the manufacturer performed mechanical testing in accordance with this recognized industry standard.

• ASTM F 1717 outlines specific test methodologies and conditions to simulate the loads and stresses that spinal implants experience in the body. The acceptance criteria for this type of testing would be a demonstration that the VIPER™ 2 System components (screws, rods) meet or exceed the established mechanical performance benchmarks (e.g., fatigue strength, static bending strength) for spinal fixation devices, and ideally, show comparable or superior performance to the predicate devices when tested under the same standard.
• By meeting the requirements of ASTM F 1717, the manufacturer provides evidence that the device is structurally sound and can withstand the mechanical environment of the spine for its intended duration, thereby establishing its safety and effectiveness from a mechanical standpoint.

Regarding the specific questions that are generally not applicable to this type of device:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a physical device mechanical test. ASTM F 1717 would involve a set number of physical prototypes for testing. The "data provenance" refers to the lab where the mechanical tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" in this context is the physical behavior of the device under mechanical load, measured by engineering equipment, not expert opinion.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results are objective measurements.
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, as this is a physical implant, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is the objective measurement of mechanical properties as defined by the ASTM standard.
8. The sample size for the training set: Not applicable (no "training set" for physical device mechanical testing).
9. How the ground truth for the training set was established: Not applicable.

In summary, the K090648 submission for the VIPER™ 2 System relies on standardized mechanical engineering tests (ASTM F 1717) and material specifications to demonstrate product performance and substantial equivalence to predicate devices, which are the primary "acceptance criteria" for spinal implant components.

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