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The specialty coils are indicated for use in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems, Magnetic Resonance Diagnostic Devices (MRDD), that produce transverse, sagittal, coronal and oblique cross sectional images, and display the internal structure and/or function of the rody. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The specialty coils are intended to be used in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems, Magnetic Resonance Diagnostic Devices. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced.

The specialty coils will include: Shoulder Large 16, Shoulder Small 16, Hand/Wrist 16 and Foot/ Ankle 16 for the existing MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems.

Acceptance Criteria and Study for Specialty Coils for MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of an AI/ML device. Instead, it refers to laboratory testing performed to demonstrate substantial equivalence to predicate devices. The details of the sample size (number of MR systems tested, number of scans performed) are not explicitly provided.

Data provenance is also not detailed, but the tests were performed in a laboratory setting, likely by the manufacturer (Siemens Mindit Magnetic Resonance Ltd. in PR. China).

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

Not applicable. This submission is for accessory coils for existing MR systems and focuses on engineering and performance criteria (SNR, image uniformity) rather than diagnostic accuracy that would require expert consensus on medical images. The "ground truth" here is objective physical measurements and comparisons to established performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. See point 3 above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This K103275 submission is for specialty coils for MR systems, not an AI/ML diagnostic device, and thus no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/ML algorithm; it is a hardware component (MRI coils). The performance metrics (SNR, image uniformity) are intrinsic to the device's physical properties.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for performance evaluation was based on objective engineering measurements of physical properties like Signal to Noise Ratio (SNR) and image uniformity. This was compared against the established performance benchmarks of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and therefore no "training set" was used.

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

Not applicable. See point 8 above.

Summary of the Study:

The study conducted to prove the device meets acceptance criteria was laboratory testing focusing on specific safety and performance parameters for the specialty coils. The primary goal was to demonstrate substantial equivalence to existing, legally marketed predicate devices.

The key performance parameters evaluated were:

• Signal to Noise Ratio (SNR): Measured and compared to predicate devices. The reported outcome was "equivalent with the predicate devices."
• Image Uniformity: Measured and compared to predicate devices. The reported outcome was "equivalent with the predicate devices."

Additionally, biocompatibility was considered, but no new tests were performed because no new materials were introduced compared to the predicate devices. The other general safety and performance parameters for MR diagnostic devices (Maximum Static Field, Rate of Change of Magnetic Field, RF Power Deposition, Acoustic Noise Level, Geometric Distortion, Slice Profile, Thickness and Gap, High Contrast Spatial Resolution) were deemed "unaffected by the modifications described within this notification."

The conclusion was that the technological differences of the new specialty coils did not raise any new questions pertaining to effectiveness compared to the predicate devices, thus supporting the claim of substantial equivalence.

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