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The intended use of the Flex and Loop Coil Set 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body.

Used in the MAGNETOM Avanto, Espree and Symphony a Tim System, the Flex and Loop Coils are indicated for use as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM Avanto, Espree and Symphony a Tim System with the Flex and Loop Coils reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The intended use of the MAGNETOM Avanto, Espree and Symphony a Tim System is not affected in any way by the use of the new Flex and Loop Coil Set 1.5 T.

The Flex and Loop Coil Set 1.5 T consists of five receive-only coils and one interface, which contains the preamplifiers, cable traps and a combiner network. The coils are two 4-channel flexible coils (Flex Coil Large and Flex Coil Small) and three linear polarized (LP) flexible coils (Loop Coil 4 cm, 7 cm and 11 cm).

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the Siemens Flex and Loop Coil Set 1.5 T:

This submission (K070629) is for a device accessory – specifically, the Flex and Loop Coil Set 1.5 T, which is a receive-only coil set used with MRI scanners. The primary focus of the evaluation is on safety and performance parameters relevant to the coil's function within an MRI system, not on a diagnostic algorithm's accuracy.

Therefore, many of the typical acceptance criteria and study components you'd see for an AI-powered diagnostic device (like sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not applicable here. This is a hardware component.

The core of the submission relies on demonstrating substantial equivalence to an existing predicate device (the Flex Loop Coil Set for 3T systems, K063373) by showing that the new device does not raise new questions of safety or effectiveness.

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are defined by general safety and performance parameters for MR diagnostic devices, as well as specific parameters for the coil set, with the implicit acceptance criterion being that the new device is "equivalent" or "unaffected" compared to the predicate or existing standards.

Study Details:

Given that this is a hardware accessory being evaluated for substantial equivalence rather than a diagnostic algorithm, much of the requested information (like sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone algorithm performance) is not relevant or applicable to this 510(k) submission.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to laboratory testing and measurements performed on the physical coil set, not a dataset of patient images.

   • Data Provenance: The "study" appears to be internal laboratory testing by Siemens AG (Germany) and Siemens Medical Solutions USA, Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic algorithms (e.g., presence/absence of disease) is not part of this submission. The "ground truth" for hardware performance is established by metrology, engineering specifications, and adherence to standards like NEMA MS-6.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, an MRMC study was not done, as this is not an AI/diagnostic algorithm device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done, as this is a hardware accessory.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense. The "ground truth" for the device's technical performance parameters (SNR, image uniformity) would be derived from engineering standards and physical measurements, often using phantoms.

7. The sample size for the training set: Not applicable. There is no "training set" for this type of device.

8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" for K070629:

The "study" described in this 510(k) is a series of laboratory tests performed on the Flex and Loop Coil Set 1.5 T to measure its technical performance (specifically Signal to Noise Ratio and Image Uniformity) according to the NEMA MS-6 standard. These measured performance characteristics were then compared to those of the predicate device.

The conclusion of the study was that the results obtained for the new device "show that they are equivalent with the predicate devices" for SNR and image uniformity. For other safety and performance parameters (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), the modifications were deemed to have no effect. Biocompatibility was assessed as acceptable because no new materials were used.

This approach is standard for demonstrating substantial equivalence for hardware accessories where the primary concern is that the new device performs within established limits and does not introduce new safety or effectiveness concerns compared to a legally marketed predicate device.

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