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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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of implants that are available in various geometries and sizes.

The provided document describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System, which is a medical device for spinal stabilization. The submission is primarily focused on demonstrating the substantial equivalence of the modified device to existing predicate devices.

Here's an analysis of the acceptance criteria and study information contained in the document, based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The document states: "Performance data per ASTM F 1717 and ASTM 1798 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification."

• ASTM F 1717: Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model. This standard evaluates the static and fatigue properties of spinal implant constructs used in corpectomy procedures.
• ASTM F 1798: Standard Guide for Evaluating the Fatigue Properties of Spinal Implants – refers to the evaluation of fatigue properties specifically (though the provided excerpt only mentions "ASTM 1798" without "F" and full title, this is the most likely relevant standard).

These tests evaluate the mechanical strength, durability, and stability of the spinal implant components under simulated physiological loading conditions. Successful completion of these tests with results comparable to, or better than, predicate devices demonstrates that the device meets the necessary mechanical performance acceptance criteria. The use of implant-grade materials (ASTM F 138, ASTM F 2229, ASTM F 136) inherently addresses biocompatibility criteria as these materials are well-established for implant use.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the number of implants or constructs tested for the performance data (ASTM F 1717 and ASTM F 1798). Test standards typically provide guidance on sample sizes, but the exact numbers used are not detailed here.
• Data Provenance: The studies are laboratory-based mechanical tests performed on the device components. The data provenance is internal to DePuy Spine, Inc. (the manufacturer) and is not clinical data from patients (retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for mechanical performance tests is defined by the objective physical and material properties measured against established engineering standards (ASTM F 1717, ASTM F 1798), not by expert human interpretation or consensus.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical tests rely on instrumental measurements and defined pass/fail criteria from engineered standards, not on human adjudication of results.

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

This is not applicable. This submission is for a physical medical implant (spinal fixation system), not an AI-powered diagnostic or assistive device where MRMC studies would be relevant.

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

This is not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this device is based on engineering standards and physical measurements. Specifically:

• Compliance with ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) to evaluate static and fatigue properties.
• Compliance with ASTM F 1798 (Standard Guide for Evaluating the Fatigue Properties of Spinal Implants).
• Use of implant-grade materials (ASTM F 138, ASTM F 2229, ASTM F 136) with documented acceptance criteria for their physical and chemical properties and biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. The testing is for verification and validation against specified performance requirements.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated above.

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