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Imaging of:

• -The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
• Fluid Visualization -
• -2D/3D Imaging
• MR Angiography/MR Vascular Imaging -

The Extra Large Body coil is an enlarged version of the current OPART™ Large Body Coil. This coil is an optional coil which was developed to allow positioning of larger sized patients in the OPART™ system. The Extra Large Body coil can be used as a standalone coil, or in conjunction with the T-spine surface coil (cleared with OPART™ system K962933). Signal is received in QD mode when used in conjunction with the T-spine surface coil.
The Extra Large Body Coil is constructed with the same materials that are currently in use for the released coil set for OPART™.

This document describes the design and regulatory approval of an "Extra Large Body Coil" for an MRI system, the OPART™. The information provided primarily focuses on establishing the device's substantial equivalence to a previously cleared device, rather than a clinical study evaluating its performance against specific acceptance criteria in a medical context.

Based on the provided text, there is no clinical study that explicitly defines and proves the device meets specific performance acceptance criteria in the way typically expected for a diagnostic AI/medical device. Instead, the submission focuses on substantial equivalence for a physical component (the coil) of an MRI system.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for algorithms or diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not applicable here because this is a hardware accessory submission based on substantial equivalence. The "performance" being evaluated is related to physical and safety parameters of the MRI coil.

Note: The "acceptance criteria" here are implicitly the existing standards and performance characteristics of the predicate device (the current Large Body Coil cleared with K962933) and general MRI safety standards. The new coil is presented as meeting these same criteria or being within acceptable limits.

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

• Test Set Description: The "test set" in this context refers to the data used to demonstrate the functionality of the new Extra Large Body Coil. This is not a clinical study test set in the sense of a patient cohort for diagnostic algorithm validation.
• Data Provenance: The document mentions "Sample phantom images and clinical images are presented from the Extra Large Body coil (Appendix 5 & 6)."
  • Sample Size: Not explicitly stated. The term "sample" implies a limited number of instances rather than a statistically powered clinical trial.
  • Provenance: The location (country of origin) of these phantom and clinical images is not specified.
  • Retrospective/Prospective: Not specified. Given it's a 510(k) for a hardware accessory, it's likely these images were collected as part of the engineering and verification process, which could be considered a form of prospective data collection for this purpose, but not a large-scale clinical trial.

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

• Not applicable. The "ground truth" for a hardware component like an MRI coil typically relates to its physical performance (e.g., signal-to-noise ratio, image uniformity, mechanical integrity) which is measured objectively using phantoms and engineering tests, and clinical image quality (which would be reviewed by radiologists). The submission does not detail an expert review process for image quality beyond a general statement that "clinical images are presented." There is no indication of a formal ground-truth establishment process by a panel of experts for diagnostic accuracy in this submission.

4. Adjudication Method for the Test Set

• Not applicable. As a hardware submission focused on substantial equivalence and safety, there is no mention of an adjudication method for a test set in the context of diagnostic performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is typically used for evaluating the performance of diagnostic algorithms or imaging techniques, often comparing human reader performance with and without AI assistance. This submission is for a physical MRI coil, and such a study is not relevant to its regulatory approval process described here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is a hardware component. The concept of an "algorithm only" or "human-in-the-loop" study does not apply.

7. Type of Ground Truth Used

• In this context, the "ground truth" is primarily derived from:
  • Engineering Specifications: Testing the coil against predefined physical and electromagnetic parameters (e.g., static field strength, SAR, acoustic noise levels, specification volumes).
  • Phantom Imaging: Objective measurements of image quality (e.g., signal-to-noise, uniformity) using standardized phantoms.
  • Clinical Image Appearance: Subjective assessment of image quality and diagnostic utility from "clinical images" (though the criteria and expert review process are not detailed in this summary).
• There's no mention of pathology, long-term outcomes data, or expert consensus in the diagnostic sense being used for ground truth in this specific submission.

8. Sample Size for the Training Set

• Not applicable. This submission is for a hardware component, not an AI/ML algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided text.

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