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The EXPEDIUM Spine System is intended for non-cervical, non-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 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.

The Expedium Spinous Process Fusion Plate is not intended for stand-alone use. When used with DePuy Spine VBR Spinal System components the Expedium Spinous Process Fusion Plate is intended for the following conditions:

• 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)
• tumor

The EXPEDIUM Spine System Spinous Process Fusion Plates are available in various lengths and spinous process heights. The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F-136 implant grade titanium alloy.

The provided text is a 510(k) summary for the "EXPEDIUM™ Spine System Spinous Process Fusion Plates," a medical device. It does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, which is typically where such criteria and studies are relevant (e.g., for AI/ML devices).

Instead, this document is a premarket notification for a predicate device. It addresses its intended use, materials, and substantial equivalence to previously marketed devices. The phrase "Performance data were submitted to characterize the additional EXPEDIUM Spine System components" is present, but it does not detail the nature of these performance data or any specific acceptance criteria or study findings.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used (expert consensus, pathology, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is from 2005, well before the widespread use of AI/ML in medical devices that necessitates the detailed performance studies you're asking about. The "performance data" mentioned likely refers to mechanical testing (e.g., fatigue, static strength) to ensure the implant's structural integrity, rather than diagnostic accuracy.

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