(128 days)
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional 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 the scan.
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a ultra-wide patient bore size design. 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 Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
The provided text is a 510(k) Summary for the uMR Omega Magnetic Resonance Diagnostic Device. It compares the proposed device to a predicate device (uMR 780) to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.
The document focuses on technological characteristics, safety, and effectiveness comparisons to a previously cleared device. It does not contain information about acceptance criteria in the typical sense of quantitative performance metrics for disease detection or diagnosis, nor does it describe a study specifically designed to meet such criteria. Therefore, most of the requested information cannot be extracted from this document.
However, based on the non-clinical and clinical tests mentioned, some inferences can be made, though they do not directly answer all the questions.
Information that CANNOT be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the uMR Omega. It primarily focuses on showing that its technical specifications and image quality are comparable to or better than the predicate device.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is a magnetic resonance diagnostic device, not an AI-assisted diagnostic tool in the sense of aiding human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a diagnostic imaging device, not primarily an AI algorithm for interpretation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any performance evaluation.
- The sample size for the training set: Not applicable, as this is primarily a hardware/software system for imaging, not a machine learning algorithm that requires a "training set" in the conventional sense.
- How the ground truth for the training set was established: Not applicable for the reasons above.
Information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
As mentioned, there isn't a table for diagnostic performance acceptance criteria. However, the document does list technical parameters and safety compliance as criteria. The "Reported Device Performance" here would refer to the device meeting these technical and safety standards, and demonstrating image quality comparable to the predicate.
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance (Inferred/Stated) |
|---|---|---|
| Safety Standards | Compliance with: |
- ES60601-1 (Medical Electrical Equipment - Basic Safety)
- IEC 60601-1-2 (EMC)
- IEC 60601-2-33 (MR Equipment Particular Requirements)
- IEC 60825-1 (Laser Safety)
- ISO 10993-5 (Cytotoxicity)
- ISO 10993-10 (Irritation & Sensitization) | Demonstrated compliance with all listed standards.
- Patient-contact materials tested and showed no cytotoxicity, irritation, or sensitization. |
| Image Quality (Non-clinical) | Compliance with standards for: - Signal-to-Noise Ratio (SNR) (MS 1, 6)
- Geometric Distortion (MS 2)
- Image Uniformity (MS 3, 6)
- Slice Thickness (MS 5) | Testing based on NEMA Standards (MS 1, 2, 3, 5, 6, 9) was performed.
(The document states: "The test results demonstrated that the device performs as expected...") The technical specifications like magnet homogeneity (e.g., 2.3ppm @ 50cm DSV) and gradient amplitude (45mT/m) are improvements or comparable to the predicate and contribute to image quality. |
| Physical Parameters | - Field Strength: 3.0 Tesla - Magnet Type: Superconducting
- Patient Bore: 75cm
- Max Gradient Amplitude: 45mT/m
- Max Slew Rate: 200T/m/s
- Receive Channels: Up to 96
- Max Support Patient Weight: 310 kg | - 3.0 Tesla (Met)
- Superconducting (Met)
- 75cm (Met; larger than predicate 65cm)
- 45mT/m (Met; higher than predicate 42mT/m)
- 200T/m/s (Met; same as predicate)
- Up to 96 (Met; more than predicate 48)
- 310kg (Met; increased from predicate 250kg) |
| Clinical Performance | Ability to generate diagnostic quality images. | - "A volunteer study was used to determine the safety limits associated with gradient-A induced nerve stimulation." - "Sample clinical images were provided to support the ability of uMR Omega to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for clinical image review: Not specified, only "Sample clinical images were provided".
- Data provenance: Not specified. The sponsor is Shanghai United Imaging Healthcare Co., Ltd. in China, but the origin of clinical images is not stated. It mentions a "volunteer study" but the number of volunteers is not specified.
- Retrospective or prospective: Not specified for the clinical images, though the "volunteer study" would be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified. The document states "when interpreted by a trained physician" in its Indications for Use, but this is general for MRDDs, not for the specific evaluation study.
- Qualifications of experts: Not specified beyond "trained physician."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests (e.g., SNR, uniformity), the "ground truth" is based on adherence to NEMA standards and physical measurements.
- For the "clinical images," the document only states they were provided to "support the ability... to generate diagnostic quality images." It does not specify how "diagnostic quality" was formally assessed or what independent ground truth (e.g., correlating with pathology, outcomes, or expert consensus) was used to validate the diagnostic information derived from these images.
§ 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.