(23 days)
The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards. uMR 680 has been previously cleared by FDA via K222755. The modification performed on uMR 680 (K222755) in this submission is due to the addition of - Breast Coil -24 - epi_se_mre - MRE (Magnetic Resonance Elastography) The modification does not affect the intended use or alter the fundamental scientific technology of the device.
The provided text describes the acceptance criteria and the study results for the Shanghai United Imaging Healthcare Co., Ltd. uMR 680 Magnetic Resonance Diagnostic Device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Breast Coil - 24 | ||
| Surface heating | The maximum temperature of all temperature probes shall not exceed 41 °C. | Pass |
| General electrical/mechanical safety | Conform with ANSI/AAMI ES60601-1 | Pass |
| SNR and Uniformity | SNR and Uniformity shall fulfill with the design specification. | Pass |
| Biocompatibility | Materials of construction and manufacturing materials exempt from testing according to the Biocompatibility guidance (Attachment G), the 510(k) numbers for devices where these materials have been previously approved, or full biocompatibility report (assessment of sensitization, irritation and cytotoxicity risks) for components that have direct contact with the patient. | All the materials of patient-contacting components for the Breast Coil - 24 are identical to uMR Omega which was cleared in K230152 in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). |
| EMC-immunity, electrostatic discharge | Conform with IEC 60601-1-2 and IEC 60601-4-2 | Pass |
| Clinical image quality | Image quality is sufficient for diagnostic use. | The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use. |
| MRE/epi_se_mre | ||
| General electrical/mechanical safety | Conform with ANSI/AAMI ES60601-1 | Pass |
| EMC | Conform with IEC 60601-1-2 and IEC 60601-4-2 | Pass |
| Performance | Bias of accuracy, repeatability, reproducibility and parameter sensitivity shall fulfill with the design specification. | Pass |
| Clinical image quality | Image quality is sufficient for diagnostic use. | The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test beyond "phantom and volunteer test" for MRE performance and "the image generated by Breast Coil-24" for clinical image quality.
- Data Provenance: Not specified. It does not mention country of origin or if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: For clinical image quality for both Breast Coil - 24 and MRE, it states "The U.S. Board Certified radiologist approves." This implies at least one, but the exact number of radiologists is not specified.
- Qualifications of Experts: "U.S. Board Certified radiologist."
4. Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. The statement "The U.S. Board Certified radiologist approves" suggests a single expert's approval for clinical image quality assessment, rather than a multi-expert consensus method like 2+1 or 3+1.
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 explicitly mentioned as being done for this submission. The studies detailed focus on system performance parameters and clinical image quality approval by a radiologist.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a Magnetic Resonance Diagnostic Device (MRDD), which is a hardware system that produces images and physical parameters to be interpreted by a trained physician. The performance tests described (surface heating, electrical/mechanical safety, SNR, uniformity, biocompatibility, EMC, performance, and clinical image quality) are for the device itself and its components/functionalities, not for an AI algorithm working in a standalone capacity. So, this question is not directly applicable in the terms of an AI algorithm, but the system performance was evaluated standalone from human interpretation in most of the tests.
7. The type of ground truth used:
- Clinical Image Quality: Expert consensus (or approval by a U.S. Board Certified radiologist) that the image quality is sufficient for diagnostic use.
- Biocompatibility: Demonstrated by using materials identical to a previously cleared device (uMR Omega, K230152) and meeting regulatory guidance.
- Other performance metrics (Surface heating, electrical/mechanical safety, SNR, Uniformity, EMC, MRE Performance): Based on compliance with established engineering and safety standards (NEMA MS 14, ANSI/AAMI ES60601-1, NEMA MS 1, NEMA MS 3, NEMA MS 6, NEMA MS 9, IEC 60601-1-2, IEC 60601-4-2) and design specifications.
8. The sample size for the training set:
- The document does not detail any "training set" as it is describing a hardware medical device with specific new coils and pulse sequences rather than a machine learning or AI-driven diagnostic algorithm that would typically require a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML algorithm is mentioned.
§ 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.