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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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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 designs that interface to 5.5mm and 6.35mm rods and are available in various geometries and sizes.

This document describes a 510(k) premarket notification for the EXPEDIUM Spine System, a medical device for spinal fixation. It is not a traditional AI/ML device approval, therefore much of the requested information about AI model performance, training sets, and ground truth establishment is not applicable.

Here's the relevant information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document states that "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification." This implies that the acceptance criteria are tied to the standards outlined in ASTM F 1798. However, the specific quantitative acceptance criteria (e.g., maximum deflection, fatigue life, strength) and the reported performance values are not provided in the summary. The document only confirms that data was submitted, not the results themselves.

Note: For medical devices like spinal fixation systems, acceptance criteria typically involve detailed mechanical testing (e.g., static and dynamic compression, bending, torsion), biocompatibility, and material characterization to ensure safety and effectiveness. The ASTM F 1798 standard specifically deals with the fatigue testing of intervertebral body fusion devices.

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

The document describes mechanical performance testing, not data analysis or human subject testing in the traditional sense of a "test set" for an AI model. Therefore, the concept of sample size for a "test set" and "data provenance" (country of origin, retrospective/prospective) as it applies to an AI/ML device is not applicable here. The "test set" for this device would refer to the physical components subjected to mechanical tests. The specific number of components tested is not provided in the summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as this is a physical medical device (spinal fixation system) and not an AI/ML product. The "ground truth" for such a device is established through adherence to engineering specifications, material science principles, and mechanical testing standards (like ASTM F 1798). Experts involved would be engineers, material scientists, and potentially surgeons for clinical relevance, but their role is not in establishing a data "ground truth" as it would be for an AI model.

4. Adjudication Method for the Test Set

This concept is also not applicable as this is a physical medical device. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert labeling or diagnoses for AI/ML training or evaluation datasets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-analysis AI/ML systems where human readers interpret cases with and without AI assistance to measure improved performance. This device is a physical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable as the device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and mechanical test results. Specifically, the summary states "Performance data per ASTM F 1798 were submitted." ASTM F 1798 is a standard specification for fatigue test performance of spinal artificial disc prostheses and components. Therefore, the ground truth is derived from objective mechanical testing outcomes compared against established engineering standards.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML product. There is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative engineering and testing, but not in the sense of an AI training set.

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

This information is not applicable for the same reasons as #8.

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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 subject EXPEDIUM™ Spine System components are designed to accept a 6.35mm rod and are available in various geometries and sizes. The EXPEDIUM™ Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification.

The provided text is a 510(k) summary for a medical device called the "EXPEDIUM™ Spine System." This document is a regulatory submission to the FDA for a medical device and describes its intended use and materials. It does not contain information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study methodologies that would be typical for proving a device meets acceptance criteria in the manner requested.

The document states:

• "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification."

This indicates that mechanical performance data according to a specific ASTM standard (F 1798) was provided to the FDA. However, the exact acceptance criteria, the specific test results, the sample sizes for these tests, or any details about clinical studies (which would involve human readers, ground truth, etc.) are not present in this 510(k) summary. These summaries typically focus on device description, intended use, and substantial equivalence to predicate devices, rather than detailed study results.

Therefore, I cannot populate the requested table and answer the questions based solely on the provided text, as the information required to do so is not present. The document focuses on regulatory compliance based on mechanical testing and comparison to predicate devices, not on a clinical performance study with human readers or image analysis.

Ask a specific question about this device

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 subject EXPEDIUM™ Spine System components are designed to accept a 6.35mm rod and are available in various geometries and sizes. The EXPEDIUM™ Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification

The provided text is a 510(k) summary for a medical device called the EXPEDIUM™ Spine System. This document focuses on the regulatory submission process and the substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria and results as typically seen in an AI/ML device submission.

Therefore, many of the requested details about acceptance criteria, study design, and AI-specific metrics (like sample size for test/training sets, ground truth establishment, MRMC studies, or standalone performance for an algorithm) are not present in the provided text.

Here's an attempt to extract the information that is available and note what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies that the device's performance, as characterized by ASTM F 1798 standards, was sufficient to demonstrate substantial equivalence to the predicate devices. The specific thresholds or performance metrics from ASTM F 1798 are not detailed here, only that the data was submitted.

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

• Sample Size: Not applicable/Not provided. This is a spinal implant, not an AI/ML diagnostic device with a "test set" in the context of image analysis. The "performance data" likely refers to mechanical testing of the implant components.
• Data Provenance: Not applicable/Not provided in the context of clinical data for an AI/ML device. The performance data is for the physical device components.

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 with experts is generally for diagnostic or AI/ML evaluations.

4. Adjudication method 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. This is a spinal implant, not an AI-assisted diagnostic tool.

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

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

• Not applicable in the context of AI/ML. For mechanical implants, the "ground truth" would be established by the physical testing results against specified engineering standards (e.g., strength, fatigue life according to ASTM F 1798).

8. The sample size for the training set

• Not applicable/Not provided. The device does not involve machine learning.

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

• Not applicable/Not provided.

Summary of what the document focuses on:

The K063156 submission is a "Special 510(k) Submission" for additions to an existing spinal implant system (EXPEDIUM™ Spine System). The key information provided relates to:

• Device Description: The new components accept a 6.35mm rod and come in various geometries and sizes.
• Materials: ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy.
• Intended Use: Non-cervical pedicle and non-pedicle fixation for various spinal conditions in skeletally mature patients (e.g., degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Performance Data: "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM™ Spine System components..."
• Substantial Equivalence: The FDA determined the device is substantially equivalent to predicate devices (EXPEDIUM™ 5.5mm Spine System (K051024) and EXPEDIUM™ 6.35mm Spine System (K062174)).

This is a traditional medical device submission for a physical implant, not a software as a medical device (SaMD) or AI/ML-driven device, which is why the detailed questions about acceptance criteria specific to AI/ML performance are largely unanswerable from the provided text. The "acceptance criteria" here are implicitly linked to meeting the performance requirements of ASTM F 1798 to demonstrate substantial equivalence, rather than clinical performance targets for accuracy, sensitivity, or specificity of a diagnostic algorithm.

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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 6.35mm rod and are available in various qeometries and sizes.

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

The provided text describes a 510(k) premarket notification for a medical device, the EXPEDIUM Spine System. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, and therefore, it is not possible to fill out the requested table or answer the specific questions.

The document primarily focuses on:

• Device Description: What the EXPEDIUM Spine System is (components, materials).
• Intended Use/Indications: What the device is designed to treat.
• Predicate Devices: Other similar devices already on the market.
• Regulatory Information: The FDA's review and determination of substantial equivalence to existing devices.

The section titled "PERFORMANCE DATA:" merely states "Performance data were submitted to characterize the EXPEDIUM Spine System components subject of this notification." It does not provide any details about the nature of this performance data, any specific acceptance criteria, or the results of any studies.

Therefore, the requested information cannot be extracted from the provided text.

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