(72 days)
1.5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the 1.5T Brivo MR355 and 1.5T Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
1.5T Brivo MR355 and 1.5T Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T Brivo MR355 and 1.5T Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness comparable to predicate device | The device is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)." |
| Compliance with voluntary standards | Complies with IEC60601-1, IEC60601-2-33, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-6, ISO14971, ISO10993-1, and IEC62304. |
| Production of high-resolution, high signal-to-noise ratio, and short scan times | Device designed to support these characteristics. |
| Ability to produce various image types (axial, sagittal, coronal, oblique, spectroscopic, parametric maps, spectra, dynamic) | Indicated for use to produce these image types. |
| Imaging capabilities for various body regions (head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, musculoskeletal) | Indicated for imaging these body regions. |
| Images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis | Device's intended use statement includes this. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states, "Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission." However, a specific number for a "test set" (i.e., a dataset used for independent evaluation of the device's performance against ground truth) is not provided. The term "internal scans" and "sample clinical images" suggest internal testing rather than a formal test set with defined sample size.
- Data Provenance: Not explicitly stated. The company is GE Healthcare, with a submitter address in Beijing, China, but the origin of the "internal scans" and "sample clinical images" is not specified. It's safe to assume it's retrospective data gathered for internal validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not described. This submission did not involve a formal clinical study with a test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted and is not mentioned.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this device is a Magnetic Resonance Imaging System, not an AI algorithm. Its performance is inherent to its hardware and software specifications for image acquisition, not for an independent diagnostic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "internal scans" for workflow and image quality, the ground truth would likely be based on technical specifications, image quality metrics, and potentially visual assessment by technical experts or radiologists comparing against established benchmarks or the predicate device's performance. There's no mention of expert consensus for diagnostic accuracy, pathology, or outcomes data in specific clinical scenarios.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an MRI system, not an AI algorithm that requires a "training set" in the machine learning sense. The development and validation involved standard engineering processes, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there was no training set for an AI algorithm. The device's "ground truth" for its development would be based on engineering specifications, physical principles of MRI, and comparison to existing, cleared MRI systems.
Summary of the Study:
The submission explicitly states: "The subject of this premarket submission, 1.5T Brivo MR355 and 1.5T Optima MR360 did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission."
Therefore, the "study" proving the device meets acceptance criteria was primarily a non-clinical validation process (risk analysis, requirements, design reviews, module verification, system verification, performance testing, safety testing, simulated use testing) demonstrating compliance with voluntary standards and substantial equivalence to a predicate device (1.5T Brivo MR355 and 1.5T Optima MR360 K103330). The "acceptance criteria" were implied to be the device's ability to produce high-quality MRI images across various body parts, consistent with its intended use and comparable to the predicate device's performance, as verified through internal testing and compliance with relevant standards. No formal clinical efficacy or diagnostic accuracy studies involving patient outcomes or expert adjudication were conducted or deemed necessary for this 510(k) clearance.
§ 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.