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The 16CH Flex SPEEDER Medium is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The 16ch Flex SPEEDER Large coil is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are intended to be used for general anatomies.

This document describes the acceptance criteria and the study conducted to prove that the 16ch Flex SPEEDER Medium 1.5T and 16ch Flex SPEEDER Large 1.5T coils meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Clinical images were obtained from "volunteer scanning of general human anatomy." The exact number of volunteers is not specified.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as clinical images were "obtained for the 16CH Flex SPEDER Medium and Large 1.5T from upper and lower extremities, chest, abdomen, pelvis, head, neck and spine."

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

• The document states that the diagnostic images are "interpreted by a trained physician." It does not specify the number of physicians, their specific qualifications (e.g., years of experience), or how ground truth was established by these physicians for the test set.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It only mentions that images are "interpreted by a trained physician," implying a single interpretation per image for diagnostic quality assessment.

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

• No MRMC comparative effectiveness study was done. The study compares the new device to pre-determined acceptance criteria and implicitly to the predicate device in terms of performance (e.g., "performs as well as or better than the predicate device"), but not in terms of human reader improvement with AI assistance. This is an MRI coil, not an AI-driven device.

6. Standalone Performance Study

• A standalone performance study was done for the device itself. The document describes non-clinical bench testing (SNR, uniformity, electrical safety, EMC, surface heating) and clinical imaging with volunteers to assess diagnostic image quality. This refers to the performance of the coil as a medical device without explicit human-in-the-loop performance measurement.

7. Type of Ground Truth Used

• For technical performance (SNR, uniformity, electrical safety, EMC, surface heating): Ground truth was established against engineering specifications and industry standards (NEMA MS-9, IEC, AAM/ANSI EN60601-1).
• For diagnostic image quality: The ground truth was established through visual assessment by a "trained physician" of "diagnostic quality images." This is essentially expert consensus/interpretation of the acquired images.

8. Sample Size for the Training Set

• This information is not applicable as this is a physical medical device (MR coil) and not an AI/machine learning algorithm requiring a separate training set.

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

• This information is not applicable.

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