(72 days)
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
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety Parameters | |
| Static Field Strength | Unaffected by the modifications described within this notification. (Implies meeting previous established safety levels for Magnetom Harmony and Symphony system) |
| RF Exposure | Unaffected by the modifications described within this notification. (Implies meeting previous established safety levels for Magnetom Harmony and Symphony system) |
| Performance Levels | |
| High Contrast Spatial Resolution | Unaffected by the modifications described within this notification. (Implies meeting previous established performance levels for Magnetom Harmony and Symphony system) |
| Slice Thickness | Unaffected by the modifications described within this notification. (Implies meeting previous established performance levels for Magnetom Harmony and Symphony system) |
| Geometric Distortion | Unaffected by the modifications described within this notification. (Implies meeting previous established performance levels for Magnetom Harmony and Symphony system) |
| SNR (Signal-to-Noise Ratio) | Additional SNR measurements were performed for the new imaging coil & presented in this documentation. (Specific numeric results or thresholds are not provided in this summary.) |
| Image Uniformity | Additional image uniformity measurements were performed for the new imaging coil & presented in this documentation. (Specific numeric results or thresholds are not provided in this summary.) |
Study Details
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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. -
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. -
Adjudication method for the test set:
Not applicable, as no expert review or diagnostic test set requiring adjudication is described. -
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. -
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. -
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. -
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. -
How the ground truth for the training set was established:
Not applicable, for the same reason as above.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.