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Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.

Model 475 8 Channel T/R Phased Array Lower Extremity Coil. Compatible with GE and Siemens 1.5T and 3.0T MR Systems.

This document is a 510(k) premarket notification for a new MRI coil, the Model 475 8 Channel T/R Phased Array Lower Extremity Coil. It describes the device's characteristics and its substantial equivalence to a predicate device, focusing on safety and imaging performance parameters.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document describes premarket notification (510(k)) as the "study" that proves the device meets the acceptance criteria. This is not a clinical study in the traditional sense, but rather a submission demonstrating "substantial equivalence" to a legally marketed predicate device. The "study" here refers to the engineering and comparative analysis performed by the manufacturer, IGC-Medical Advances Inc., to show that their new coil is as safe and effective as the predicate.

The document states: "The GE and Siemens 1.5T and 3.0T MRI systems, operated with the Medical Advances 8 Channel T/R Phased Array Lower Extremity Coil, are substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate devices listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels..." and "The use of these coils does not affect the GE or Siemens 1.5T and 3.0T system safety parameter specifications."

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

• Sample Size: Not explicitly stated as this is not a clinical trial with a defined 'test set' of patient data in the typical sense. The evaluation is based on technical specifications and comparisons to the predicate device.
• Data Provenance: Not applicable. The "data" here refers to the technical specifications and performance characteristics of the new coil compared to the predicate, likely derived from internal engineering tests and simulations, rather than patient data.

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

This information is not provided in the document. As this is a 510(k) submission focused on technical equivalence to a predicate MRI coil, rather than a diagnostic device that interprets medical images, the establishment of "ground truth" by medical experts for a "test set" of images is not applicable in the way it would be for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers interpret medical images and their interpretations need to be reconciled to establish a ground truth. This document pertains to the technical performance of an MRI coil, not its diagnostic interpretation by human readers.

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

No. An MRMC study was not done. MRMC studies are used to evaluate the performance of diagnostic imaging devices or AI algorithms by comparing the accuracy of multiple human readers with and without the assistance of a new technology across multiple cases. This submission is for an MRI coil, which is a hardware component, not a diagnostic interpretation tool, and therefore an MRMC study is not relevant.

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

Not applicable. This device is an MRI coil, a hardware component for image acquisition, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

7. The Type of Ground Truth Used:

Not applicable in the typical sense of diagnostic ground truth. The "ground truth" for this submission is established by the known, legally marketed predicate device's safety and performance characteristics. The new coil's performance is compared against these established technical benchmarks. No pathology, expert consensus on patient outcomes, or other clinical "ground truth" is used in this context. The "truth" is whether the new coil performs at least as safely and effectively as the predicate, or better in some aspects, based on engineering specifications.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware component (MRI coil), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.

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