(25 days)
The 16 Breast Coil for Canon 1.5T MRI Scanners are designed to provide magnetic resonance images of breast anatomy when used in conjunction with a magnetic resonance scanner. These images are interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.
The 16 Breast Coil is a receive-only coil to be used with 1.5T Orian and Fortian Canon MR scanners. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The 16 Breast Coil is a phased array design consisting of patient support with three different coil combinations (2, 10 or 16 channels). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The 16 Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the 16 Breast Coil allows each imaging element to be independently positioned and configured for each patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject 16 Breast Coil also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s).
This looks like a 510(k) summary for a medical device, specifically an MRI breast coil. These summaries often describe equivalence to a predicate device rather than presenting detailed "acceptance criteria" and "device performance" in the way one might expect for a novel AI algorithm or a diagnostic test with specific sensitivity/specificity targets.
Based on the provided text, the device is an MRI Receive-only Coil, and its clearance is based on the Safety and Performance Based Pathway for magnetic resonance (MR) receive-only coils. This pathway emphasizes demonstrating that the device is as safe, as effective, and performs as well as or better than a predicate device by meeting criteria outlined in specific FDA guidance documents.
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 detail specific quantitative acceptance criteria (e.g., SNR values, uniformity percentages) in a table format that would typically be found in a performance study for a novel diagnostic device. Instead, it states that the device demonstrated substantial equivalence by "meeting all criterion in the guidance 'Magnetic Resonance (MR) Receive-only Coil -Performance Criteria for Safety and Performance Based Pathway' issued on December 11. 2020."
The performance parameters studied are:
| Acceptance Criterion (Guidance) | Reported Device Performance (Summary of results) |
|---|---|
| Non-Clinical Performance Testing: | |
| IEC 60601-1 General electrical/mechanical safety | Met (Implied by "safety and effectiveness requirements...were met") |
| IEC 60601-1-6 Usability | Met (Implied by "safety and effectiveness requirements...were met") |
| IEC 60601-1-2 EMC - Immunity, ESD | Met (Implied by "safety and effectiveness requirements...were met") |
| IEC 60601-2-33 Basic safety and essential performance of MR equipment | Met (Implied by "safety and effectiveness requirements...were met") |
| NEMA MS 1, 3, 9 Image signal-to-noise (SNR) and Image uniformity | Met (Implied by "safety and effectiveness requirements...were met" and "images produced...are of sufficient quality") |
| NEMA MS 14 Surface heating | Met (Implied by "safety and effectiveness requirements...were met") |
| ISO 10993-1 Biological safety evaluation | Met (Implied by "safety and effectiveness requirements...were met") |
| ISO 17664-2 Cleaning and disinfection validations | Met (Implied by "safety and effectiveness requirements...were met") |
| Clinical Performance Testing: | |
| Acquired Image quality (for diagnostic use) | Assessed by U.S. Board Certified radiologist to confirm images are of sufficient quality for diagnostic use. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Performance Testing - Clinical," where "Acquired Image quality was assessed by the U.S. Board Certified radiologist." However, it does not specify the sample size (number of patients or scans) used for this clinical assessment, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The text states: "Acquired Image quality was assessed by the U.S. Board Certified radiologist".
- Number of experts: Singular - "radiologist" (implies one, though it's possible it refers to a group in singular form).
- Qualifications: "U.S. Board Certified radiologist". No specific years of experience are mentioned.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the clinical image quality assessment. It simply states the images were "assessed by the U.S. Board Certified radiologist."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes a study focused on the performance of the device itself (the breast coil) to demonstrate substantial equivalence to a predicate device, not an AI algorithm assisting human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed/reported here.
6. If a Standalone (Algorithm Only) Performance Was Done
No. This device is an MRI receive-only coil, a hardware component. It is not an AI algorithm, so the concept of standalone (algorithm only) performance is not applicable. The performance described relates to image acquisition quality.
7. The Type of Ground Truth Used
For the clinical assessment of image quality, the "ground truth" was indirectly established by the expert opinion/assessment of a U.S. Board Certified radiologist confirming "images produced on the subject coil are of sufficient quality for diagnostic use." This is an expert consensus on image utility, not an objective "ground truth" diagnosis like pathology.
8. The Sample Size for the Training Set
Not applicable. This is a hardware component (MRI coil), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI algorithm training set.
§ 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.