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The Knee/Foot/Ankle Coil is a receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in conjunction with a PHILIPS 1.5T MRI scanner. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

The Knee/Foot/Ankle Coil consists of three parts, bottom part with a cable and a base plate, a knee part and a foot part. The combination of the bottom part and knee part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in magnetic resonance imaging systems. Combination of bottom part and foot part forms a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of foot and ankle. These images, when interpreted by a trained physician, vields information that may assist in diagnosis.

Acceptance Criteria and Device Performance Study for CG-KFC18-H150-AP

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for the performance testing.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

3. Number and Qualifications of Experts for Ground Truth

The provided text does not mention the use of experts to establish ground truth for the test set. The stated purpose of the images is "when interpreted by a trained physician, yields information that may assist in diagnosis," implying diagnostic interpretation, but details on ground truth establishment are absent.

4. Adjudication Method

The provided text does not describe any adjudication method used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted. The study focused on the technical performance of the MRI coil itself (SNR and uniformity) compared to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The performance testing focused on the intrinsic characteristics of the device, specifically its Signal-to-Noise Ratio (SNR) and image uniformity in comparison to a predicate device. This evaluates the device's technical capabilities in isolation.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/medical device studies (e.g., pathology, expert consensus on disease presence) is not applicable or mentioned in this context. The study assessed the technical image quality metrics (SNR and uniformity) against a predicate device, which serves as the "truth" or benchmark for comparison of physical performance characteristics.

8. Sample Size for Training Set

The concept of a "training set" is not applicable to this device. This is a medical device (an MRI coil), not an AI algorithm that requires training data.

9. How Ground Truth for Training Set was Established

As this is not an AI algorithm, the concept of a training set and its associated ground truth is not relevant.

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