(14 days)
The 3.0T HD Breast Array is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the 3.0T HD Breast Array. The indications for use are the same as for standard MR Imaging. The 3.0T HD Breast Array is designed for use with the 3.0T Signa Excite MRI scanner, manufactured by General Electric Healthcare.
The 3.0T HD Breast Array is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The 3.0T HD Breast Array is designed to offer optimized imaging capabilities and maximum lateral and medial access to each breast for biopsy procedures.
The provided text describes a 510(k) submission for a medical device, the "3.0T HD Breast Array." This device is a receive-only RF coil for MRI, intended for obtaining MR images of the breast and axillary tissue. The submission aims to demonstrate substantial equivalence to a previously cleared device (1.5T Liberty 9000 8-channel Breast coil).
It is important to note that a 510(k) submission for a device like an MRI coil typically focuses on physical and electrical performance rather than diagnostic accuracy as a standalone algorithm would. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted in the context of a medical device hardware submission, not an AI/algorithm submission. Many of the requested fields are specifically related to AI/algorithm performance studies and will likely be "Not applicable" or "Not provided" for this type of device submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "Testing was performed to demonstrate that the design modifications to the 3.0T HD Breast Array meet predetermined acceptance criteria." However, specific acceptance criteria and reported device performance metrics are not detailed in the provided text. The overall "performance" claimed is substantial equivalence to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Not detailed in submission) | Reported Device Performance (Not detailed in submission) |
|---|---|---|
| Electrical Performance | Expected criteria for an RF coil (e.g., Signal-to-Noise Ratio (SNR), homogeneity, impedance matching, RF safety). | The submission implies that these criteria were met to demonstrate substantial equivalence to the predicate device. |
| Mechanical Performance | Expected criteria for device durability, patient positioning, biopsy access, etc. | The submission implies that these criteria were met to demonstrate substantial equivalence to the predicate device. |
| Safety | Expected criteria for electrical safety, heating, biocompatibility (if applicable to patient contact surfaces). | The submission states: "Usage of the USA Instruments 3.0T HD Breast Array does not result in any new potential hazards." |
| Compatibility | Compatibility with the 3.0T Signa Excite MRI scanner. | The device is "designed for use with the 3.0T Signa Excite MRI scanner." |
2. Sample Size Used for the Test Set and Data Provenance
This information is Not Applicable / Not Provided in the context of an MRI coil hardware submission. There isn't an "algorithm" being tested with a dataset of medical images. The testing would be on the physical device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is Not Applicable / Not Provided. Ground truth, in the sense of expert annotation of medical images, is not relevant for the performance testing of an MRI coil.
4. Adjudication Method for the Test Set
This information is Not Applicable / Not Provided. Adjudication methods are used for resolving disagreements among experts annotating medical data; this is not relevant for an MRI coil hardware test.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done/not described for this device. Such studies are typically for evaluating the diagnostic performance of software or imaging modalities, often with human readers involved. This submission is for an MRI coil.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is Not Applicable / Not Provided. This is an MRI coil, not an algorithm.
7. The Type of Ground Truth Used
This information is Not Applicable / Not Provided. Ground truth, in the sense of pathology, expert consensus, or outcomes data, is not relevant for the performance testing of an MRI coil. The "ground truth" for this device's performance would be engineering specifications and safety standards.
8. The Sample Size for the Training Set
This information is Not Applicable / Not Provided. There is no "training set" in the context of an MRI coil hardware submission.
9. How the Ground Truth for the Training Set was Established
This information is Not Applicable / Not Provided. There is no "training set" or corresponding ground truth for this type of device.
Summary of the Study Proving Substantial Equivalence (as described in the text):
The provided text states: "Testing was performed to demonstrate that the design modifications to the 3.0T HD Breast Array meet predetermined acceptance criteria." The study's objective was to demonstrate substantial equivalence to the predicate device, the "1.5T Liberty 9000 8-channel Breast coil (K041695)." The main difference being the coil was "retuned for operation in a 3.0T magnetic field instead of a 1.5T field strength."
The conclusion drawn from this testing was: "It is the opinion of USA Instruments that the 3.0T HD Breast Array is substantially equivalent to the USA Instruments 1.5T Liberty 9000 8 channel Breast Array (K041695). Usage of the USA Instruments 3.0T HD Breast Array does not result in any new potential hazards."
While the specifics of the tests performed (e.g., SNR measurements, SAR testing, mechanical durability tests) are not detailed in the provided summary, the FDA's clearance letter indicates that they found the device substantially equivalent. The "acceptance criteria" would have been a set of engineering and safety specifications that the 3.0T HD Breast Array needed to meet, demonstrating that its performance and safety profile were comparable to the predicate device, given the change in magnetic field strength.
§ 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.