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The Siemens Magnetom CP Breast Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of the internal structures of the breast.

The CP Breast Array Coil is a receiver coil for the Magnetom Harmony and Symphony

The provided text describes specific parameters that were evaluated for the Siemens CP Breast Array Coil to demonstrate substantial equivalence to a predicate device, rather than explicit acceptance criteria with numerical thresholds. Therefore, the table below reflects what was stated to be "unaffected" or had "additional measurements performed."

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:
   The provided 510(k) summary does not specify the sample size for any clinical or laboratory test set. It broadly states that "Laboratory and clinical testing were performed to support this claim of substantial equivalence," but no details regarding the number of participants, images, or data provenance (e.g., country of origin, retrospective or prospective nature) are included. This is typical for older 510(k) summaries which focused more on technical equivalence.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not mention the use of experts to establish a ground truth for a test set. The focus is on technical performance metrics of the device as an accessory, not on diagnostic outcomes requiring expert interpretation.

3. Adjudication method for the test set:
   Not applicable, as no expert review or diagnostic test set requiring adjudication is described.

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 comparative effectiveness study was not done, and the device is a hardware component (a breast array coil) for an MRI system, not an AI-powered diagnostic tool. Therefore, questions regarding human reader improvement with AI assistance are not applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is a hardware component (an MRI coil), not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As this device is a hardware accessory, the "ground truth" for its performance is based on physical and engineering measurements of parameters like static field strength, RF exposure, spatial resolution, slice thickness, geometric distortion, SNR, and image uniformity. No clinical diagnostic ground truth (like pathology or outcomes data) is mentioned as being used to assess the coil itself.

7. The sample size for the training set:
   Not applicable, as the device is a hardware component (MRI coil), not a software algorithm that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable, for the same reason as above.

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