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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 describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System. This document is a premarket notification for a medical device and thus concerns the regulatory approval process rather than a study proving the device meets acceptance criteria through clinical or AI-related performance metrics.

The "Performance Data" section explicitly states: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which tests mechanical properties like static and fatigue strength. This indicates that the "acceptance criteria" here are likely related to meeting specific mechanical performance standards as defined by ASTM F1717, rather than clinical or "AI-related" performance criteria.

Therefore, many of the requested details in your prompt (such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or cannot be extracted from this type of regulatory submission. The device described is a physical spinal implant system, not an AI-powered diagnostic or therapeutic device.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

Explanation: The document does not provide specific numerical acceptance criteria values or detailed performance results (e.g., maximum load, cycles to failure). It only states that data per the ASTM F1717 standard were submitted, implying the device met the requirements of this standard for mechanical characterization.

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

• Sample size: Not specified. ASTM F1717 outlines testing methodologies, which typically involve a specified number of samples for mechanical testing, but the exact number used for this submission is not detailed.
• Data provenance: The testing was conducted to characterize the "subject EXPEDIUM™ Spine System components," implying in-vitro mechanical testing of the device itself.
  • Country of origin: Not explicitly stated, but the submission is to the U.S. FDA by DePuy Spine, Inc. (a U.S.-based company), suggesting the testing was likely conducted in the U.S. or by a lab that adheres to U.S. regulatory standards.
  • Retrospective or prospective: This is mechanical (in-vitro) testing of hardware, not clinical data, so the terms "retrospective" or "prospective" are not applicable.

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

Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" for mechanical performance is defined by the physical properties measured according to the ASTM F1717 standard.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human judgment or adjudication.

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. This device is a physical spinal implant system, not an AI-powered system that would involve human readers or AI assistance.

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

Not applicable. This device is a physical spinal implant system, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is the objective, measurable mechanical properties determined through standardized in-vitro testing (ASTM F1717).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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