(17 days)
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast.
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are receive only MR coils for imaging the human breast. Both coils consist of 16 coil elements. Two housing halves each contain eight independent coil elements. Seven of each are arranged in a cylindrical geometry while one element is positioned in a horizontal plane at top of the cylinder faced outwards.
The provided document describes the K083253 510(k) submission for the "16 Ch AI Breast Coil 1.5 T" and "16 Ch AI Breast Coil 3 T." This submission is for an accessory to an existing Magnetic Resonance Diagnostic Device, specifically a specialized coil for breast imaging. It claims substantial equivalence to a previously cleared predicate device, the "CP Breast Array Coil."
The document details safety and performance characteristics that were considered during the evaluation for substantial equivalence but does not describe a clinical study or specify acceptance criteria in the context of device performance metrics with numerical targets and achieved results. Instead, it focuses on laboratory testing to demonstrate equivalence based on certain technical parameters.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with explicit acceptance criteria (e.g., "SNR must be > X dB") and corresponding reported device performance values. It states that "Signal to Noise Ratio (SNR) and image uniformity tests according to IEC 62464-1 were performed... and the results presented in this submission show that they are equivalent with the predicate devices." This implies that the acceptance criterion was likely equivalence to the predicate device's performance for these metrics, rather than a specific numeric threshold.
| Performance Parameter | Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Signal to Noise Ratio (SNR) | Equivalent to predicate device (CP Breast Array Coil) | Equivalent to predicate device |
| Image Uniformity | Equivalent to predicate device (CP Breast Array Coil) | Equivalent to predicate device |
| Spectral Resolution | Equivalent to predicate device (CP Breast Array Coil) | Equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "Laboratory testing" and does not specify a sample size for a test set in the context of human subjects or clinical data. The tests performed ("Signal to Noise Ratio (SNR) and image uniformity tests according to IEC 62464-1" and "spectroscopic tests on SNR and spectral resolution") are typically conducted on phantoms or test objects rather than human subjects for pre-market clearance of an MR coil accessory. Therefore, "data provenance" (country of origin, retrospective/prospective) is not applicable in the usual sense of clinical trial data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The evaluation was based on laboratory engineering tests (e.g., SNR, image uniformity, spectral resolution) rather than clinical interpretation requiring expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes laboratory performance testing of an MR coil accessory, not a comparative effectiveness study involving human readers and AI assistance for diagnostic interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, in a sense. The testing described focuses on the intrinsic performance characteristics of the coil itself (e.g., its SNR, uniformity). This can be considered "standalone" as it evaluates the device's physical capabilities independently of human interaction for interpretation. However, it's not "algorithm only" as there's no diagnostic algorithm being evaluated.
7. Type of Ground Truth Used
The "ground truth" for the laboratory tests mentioned would be the physical properties and measurements obtained from test phantoms or standard measurement protocols (e.g., IEC 62464-1). It's not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This device is an MR coil, not an AI or machine learning algorithm that requires a training set of data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.