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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 in skeletally mature patients.

The EXPEDIUM® 4.5mm Spine System is a rod-hook-screw system. The EXPEDIUM 4.5mm Spine System proposed single and dual diameter rods are offered in titanium, stainless steel, and cobalt-chromiummolybdenum. They are available in various geometries and sizes to accommodate patient anatomy.

The provided text describes a 510(k) summary for the EXPEDIUM Spine System, which is a medical device for spinal fixation. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain any information about a study that would establish acceptance criteria for device performance based on clinical or AI-driven evaluation, nor does it provide performance data in the context of diagnostic accuracy or expert consensus.

The "Performance Data" section specifically states:
"Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification. Specifically, static and dynamic compression testing as well as static torsion testing were performed."

This indicates that the performance data submitted relates to mechanical testing of the device components (e.g., strength, durability), not to a study assessing the device's diagnostic or clinical performance in comparison to a ground truth or human experts. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided document.

Here's an attempt to address the points based on the available information, highlighting what is not present:

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

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

• Not Provided. The document refers to mechanical testing data, not clinical test set data.

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/Not Provided. The study described is mechanical testing, not a study involving expert assessment of a test set.

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

• Not Applicable/Not Provided.

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/Not Provided. This document describes a traditional medical device (spine system), not an AI-driven or diagnostic device.

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

• Not Applicable/Not Provided.

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

• For the mechanical performance, the "ground truth" or standard would be the requirements of ASTM F 1717 for spinal implant testing. The document states that performance data per ASTM F 1717 was submitted, implying compliance with the test standards.

8. The sample size for the training set

• Not Applicable/Not Provided. There is no mention of a "training set" as this is not an AI/ML device or a diagnostic performance study.

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

• Not Applicable/Not Provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical spinal implant device based on its design, materials, intended use, and mechanical performance testing according to ASTM F 1717 standards. It does not describe any studies related to clinical diagnostic performance, expert evaluations, or AI system performance, which are the typical contexts for the requested information.

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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 in skeletally mature patients.

Additional Component of the EXPEDIUM Spine System.

The EXPEDIUM Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document is a 510(k) summary for the EXPEDIUM™ Spine System, specifically for additional components. It is a submission to the FDA for market clearance, not typically a publication of a clinical study with detailed performance metrics against acceptance criteria. Therefore, the information provided is limited to what's available in such a regulatory document.

Based on the provided text, a table of acceptance criteria and reported device performance from a clinical study cannot be constructed because the document does not describe acceptance criteria for diagnostic performance or a clinical study in the way typically seen for AI/software devices.

Instead, the document states:

"PERFORMANCE DATA:
Performance data were submitted to characterize the additional components of the EXPEDIUM Spine System."

This refers to engineering performance data for a physical medical device (spinal implants), not typically diagnostic performance as would be expected for an AI/software device. The FDA's 510(k) clearance in this context relies on demonstrating substantial equivalence to predicate devices, often through mechanical testing, biocompatibility, and material characterization, rather than clinical efficacy studies with ground truth.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable or not present in this type of regulatory submission for a physical implantable device.

Here's an attempt to answer the questions based only on the provided text, noting where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable/Not provided. This document describes a physical medical device (spinal implant), not a diagnostic algorithm that would typically have a test set of data.
• Data Provenance: Not applicable/Not provided.

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

• Not applicable/Not provided. Ground truth establishment by experts is typically for diagnostic or AI devices, not for the performance data of a spinal implant.

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

• Not applicable/Not provided. This relates to diagnostic image interpretation or algorithm output, not the mechanical or material performance of a spinal implant.

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/Not provided. MRMC studies are for diagnostic interpretation (often with imaging and AI assistance), which is not the subject of this 510(k) summary.

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

• Not applicable/Not provided. This document is not about an algorithm or AI device.

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

• Not applicable/Not provided. The "performance data" mentioned would likely be based on physical measurements, material properties, and mechanical tests, not a clinical ground truth as defined for diagnostic studies.

8. The sample size for the training set

• Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set.

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

• Not applicable/Not provided. This document is not about an algorithm or AI device that would have a training set with established ground truth.

Summary based on the provided text:

The provided document is a 510(k) summary for a physical medical device, the EXPEDIUM™ Spine System, an implantable spinal fixation device. The performance data mentioned refers to engineering tests and characterization (e.g., mechanical strength, biocompatibility, material properties) to demonstrate substantial equivalence to previously cleared predicate devices, not clinical efficacy or diagnostic performance. Therefore, the typical criteria and study design elements requested for an AI/software device or a diagnostic device are not present in this document.

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