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The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. For use with Siemens 0.55T, 1.5T, and 3T systems

These three models are known as specialty MRI coils for use in generating MRI images of the female breast. MRI procedures that include the evaluated device are conducted for clinical purposes at the discretion of the ordering physician. The Breast BI Coil Sets described in this document has been designed, depending upon model type, for use with an MRI system with field strength of 0.55T 1.5T or 3.0T. The coil system consists of pure receiving coils for the reception of high frequency signals from the hydrogen-('H)-nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRI device. The precise magnetization induces potential differences in the Breast Bl Coil Sets which are digitized and further processed in the MRI system. The Breast BI Coil Sets consist of a rigid Coil Frame with Immobilization, Biopsy and Breast Coil System. Imaging is performed with a 7-Channel "phased array" Coil developed and manufactured by the NORAS company. The coils are mounted in the rigid Coil Frame. Interconnection is handled by the software of the MRI. The Breast BI Coil Set 0.55T is an innovative concept designed to offer flexible use to meet the needs of the procedure to be performed in your clinic. It is removable and enables the biopsy device to be used with the respective corresponding coil with the different field strengths. The rigid Coil Frame forms a high resolution, 7-channel "phased array" configuration. The Coil Frame is made of fiberglass-reinforced polycarbonate. The surface has been finished with Alexit biocompatible coating. The breast cushion and the headrest are made of PE

The provided text describes a 510(k) premarket notification for a new set of breast MRI coils. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials typical for novel high-risk devices. Therefore, the information provided focuses on engineering and performance testing, largely comparing the new device to existing cleared devices.

As such, the document does not detail a study that proves the device meets specific performance-based acceptance criteria in a clinical setting related to diagnostic accuracy or AI performance. Instead, it focuses on demonstrating that the new coils are functionally equivalent and equally safe compared to predicate devices through engineering and performance testing.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample sizes for medical image analysis, expert ground truth establishment, MRMC studies, or AI performance are not applicable or not provided in this document because the device itself is an MRI coil, not an AI diagnostic algorithm or a device requiring a clinical efficacy study beyond demonstrating image quality and safety.

However, I can extract the information relevant to the performance and safety testing that was conducted according to the document.

Acceptance Criteria and Device Performance (Based on Engineering and Safety Testing):

The acceptance criteria for this device are not defined in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) as it is an imaging coil, not a diagnostic algorithm. Instead, the performance is assessed based on engineering standards for image quality and safety.

Since the device is an MRI coil and not an AI-powered diagnostic tool, the following sections are largely not applicable or the information is not provided in this type of submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable / Not Provided for typical clinical diagnostic test set for AI. The "clinical sample test images" mentioned were likely acquired for qualitative assessment of functional performance (image quality) of the coil itself rather than a diagnostic study with a human-in-the-loop or standalone AI. The sample size for this qualitative assessment is not specified, nor is the provenance of the patients from whom the images were acquired.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable / Not Provided. Ground truth in the context of diagnostic accuracy via expert consensus is not described as the focus is on the performance of the coil itself in generating images, not on interpreting those images for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable / Not Provided. Similarly, no adjudication method is described as the document does not detail a diagnostic performance study.

5. 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:

   • Not Applicable / Not Done. This is an MRI coil, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable / Not Done. This is an MRI coil, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not Applicable / Not Provided. For the image quality assessment, the "ground truth" is adherence to engineering specifications for SNR, uniformity, etc., and qualitative assessment of images ("good coverage, quality, uniformity and SNR") by experienced personnel.

8. The sample size for the training set:

   • Not Applicable / Not Provided. This document is for an MRI coil, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

   • Not Applicable / Not Provided. As above, this document is for an MRI coil, not an AI model.

In summary, the provided document is a 510(k) submission for a medical device (MRI coils), not an AI algorithm or a device requiring a clinical study for diagnostic efficacy. The acceptance criteria and "study" are therefore focused on demonstrating the device's conformance to established engineering standards for safety and image quality, and proving its substantial equivalence to previously cleared predicate devices.

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