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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 document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through benchmark testing rather than studies involving human participants, AI, or ground truth establishment in a diagnostic context. Therefore, many of the requested categories related to AI performance, reader studies, and ground truth are not applicable to this type of regulatory submission.

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

For this device type (spinal fixation system), acceptance criteria relate to mechanical and material performance, ensuring safety and efficacy comparable to predicate devices. The study performed was a mechanical characterization study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated in terms of individual units tested, but the performance data was generated for "subject EXPEDIUM™ Spine System components," implying a sufficient number of samples to characterize mechanical properties as per ASTM F1798. For mechanical testing, sample sizes are determined by the specific standards to achieve statistical significance for the property being measured (e.g., usually 5 or more samples per test condition).
• Data Provenance: The data is from mechanical and material testing conducted by the manufacturer, DePuy Spine, Inc. (located in Raynham, MA, USA). This is prospective in the sense that the tests were specifically performed to support this 510(k) submission.

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. This is a mechanical device, not a diagnostic one that requires ground truth established by medical experts for diagnostic accuracy. The "ground truth" here is adherence to engineering standards and material specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No human adjudication method is relevant for mechanical testing results against an engineering standard like ASTM F1798. The 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. This submission is for a spinal implant system, not a diagnostic AI device. No MRMC studies were conducted.

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

• Not Applicable. This is a mechanical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Engineering Standards and Material Specifications: The "ground truth" for this device's performance is its compliance with established mechanical testing standards (specifically ASTM F1798) and its use of implant-grade materials (ASTM F136 titanium alloy, ASTM F138 stainless steel). The regulatory review determines if these results demonstrate substantial equivalence to predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning/AI model.

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

• Not Applicable. No training set was used.

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