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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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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 type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data and material specifications. It does not contain information about software-based AI or diagnostic algorithms that would typically have the specific acceptance criteria and study details you've requested.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (in the context of AI/diagnostic algorithms).
• Sample size used for the test set and data provenance.
• Number of experts and qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Here's what the provided text does say about performance and acceptance:

The submission states:

• Performance Data: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification."

This indicates that the device's mechanical performance was evaluated according to the standard ASTM F 1717, which is a standard specification for spinal implant constructs in a vertebrectomy model. The acceptance criteria would be defined by the thresholds and methodologies within ASTM F 1717, and the "study" demonstrating this would be the physical testing conducted according to that standard. However, the specific results of that testing or the explicit acceptance criteria (e.g., minimum fatigue life, maximum displacement under load) are not detailed in this summary document.

Essentially, for a mechanical device like a spinal fixation system, "acceptance criteria" relate to its structural integrity, stability, and biomechanical performance under simulated physiological loads, often verified through standardized testing. The "study" proving this is the physical laboratory testing.

In summary, based on the provided text, the device meets its acceptance criteria by demonstrating conformance to ASTM F 1717, a recognized standard for spinal implant testing. However, the detailed numerical acceptance criteria and specific test results are not part of this 510(k) summary.

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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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