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

Expedium Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes. The Expedium Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification

The provided text is a 510(k) summary for the Expedium Spine System, a medical device. This document focuses on establishing the substantial equivalence of the new device to previously cleared predicate devices, rather than on detailed performance criteria or clinical study results in the context of an AI/ML device.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves a device meets them, particularly those related to AI/ML performance metrics (such as effect size for human readers with AI assistance, standalone algorithm performance, or training set details), are not applicable to this 510(k) submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no explicit acceptance criteria or detailed performance metrics reported in the way one would expect for an AI/ML device or a device requiring specific functional performance benchmarks to be met numerically. The 510(k) process for this type of device (spinal fixation system) primarily relies on:

• Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is proving that the new device is substantially equivalent to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and intended use.
• Mechanical/Material Performance: The "Performance Data" section states that "Performance data were submitted to characterize the additional Expedium Spine System components." While the specific data is not detailed in this summary, it would typically include mechanical testing (e.g., fatigue, static strength, pull-out strength in bone surrogates) to ensure the device meets established engineering standards and comparable performance to the predicate device. However, no numerical acceptance criteria or results are provided in this summary.

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

• Not Applicable in the provided text: This type of information (sample size, data provenance for a test set) is typically relevant for clinical studies or performance validation of AI/ML models. This 510(k) summary does not describe such a test set. The "performance data" mentioned would likely be from bench tests on physical devices, not a dataset of patient cases.

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

• Not Applicable: There is no mention of experts establishing ground truth for a test set. This is a medical implant, not a diagnostic or AI-powered device.

4. Adjudication method for the test set:

• Not Applicable: No test set or adjudication method is described.

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 is a spinal fixation system, not an AI-powered diagnostic tool. MRMC studies or human reader improvement with AI are not relevant.

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

• Not Applicable: This is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• Not Applicable in the context of software/AI: For a mechanical device, "ground truth" would relate to material properties, design specifications, and mechanical performance standards, which are evaluated through engineering tests and adherence to manufacturing controls.

8. The sample size for the training set:

• Not Applicable: No training set is involved for this type of device.

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

• Not Applicable: No training set is involved.

Summary of what is available from the text relevant to the device's assessment:

• Predicate Devices: The device establishes substantial equivalence to the Expedium Spine System (Merlin Spine System) (K033901) and Expedium Spine System (K041119). This implies that a primary "acceptance criterion" is that the new device performs equivalently to these legally marketed devices in terms of safety and effectiveness.
• Performance Data: The document states that "Performance data were submitted to characterize the additional Expedium Spine System components." This would refer to engineering and mechanical testing data, not clinical study results or AI performance metrics. The specific results are not included in this summary.
• Materials: Manufactured from ASTM F-138 implant grade stainless steel and ASTM F-136 implant grade titanium alloy. This implies adherence to established material standards is an "acceptance criterion."
• Intended Use: The device is intended for noncervical pedicle and nonpedicle fixation for various spinal conditions, as detailed in the "Indications for Use" section. This aligns its intended therapeutic purpose.

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