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The EXPEDIUM Spine System is 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 Spine 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); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The subject EXPEDIUM™ Spine System components are designed to accept a 4.5mm rod and are available in various geometries and sizes.

The provided text is a 510(k) summary for the EXPEDIUM Spine System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data and material specifications. It does not contain information about software-based AI or diagnostic algorithms that would typically have the specific acceptance criteria and study details you've requested.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (in the context of AI/diagnostic algorithms).
• Sample size used for the test set and data provenance.
• Number of experts and qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Here's what the provided text does say about performance and acceptance:

The submission states:

• Performance Data: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification."

This indicates that the device's mechanical performance was evaluated according to the standard ASTM F 1717, which is a standard specification for spinal implant constructs in a vertebrectomy model. The acceptance criteria would be defined by the thresholds and methodologies within ASTM F 1717, and the "study" demonstrating this would be the physical testing conducted according to that standard. However, the specific results of that testing or the explicit acceptance criteria (e.g., minimum fatigue life, maximum displacement under load) are not detailed in this summary document.

Essentially, for a mechanical device like a spinal fixation system, "acceptance criteria" relate to its structural integrity, stability, and biomechanical performance under simulated physiological loads, often verified through standardized testing. The "study" proving this is the physical laboratory testing.

In summary, based on the provided text, the device meets its acceptance criteria by demonstrating conformance to ASTM F 1717, a recognized standard for spinal implant testing. However, the detailed numerical acceptance criteria and specific test results are not part of this 510(k) summary.

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