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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 in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of designs that interface to 5.5mm and 6.35mm rods and are available in various geometries and sizes.

The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System. It focuses on the regulatory approval process and device description rather than performance studies or acceptance criteria for a system that uses AI.

Therefore, I cannot extract the requested information regarding:

• 1. A table of acceptance criteria and the reported device performance
• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

The document only mentions:

• 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 mechanical performance testing, likely related to strength and fatigue, was conducted according to a specific ASTM standard (ASTM F 1717 for Spinal Implant Constructs in a Corpectomy Model). However, it does not provide the acceptance criteria or results of these tests, nor does it relate to any AI/algorithm performance.

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