(85 days)
The Signa HFO/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The HFO/i system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the HFO/i system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the HFO/i may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
The Signa HFO/i Magnetic Resonance System is a modification to the Signa Horizon CX Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D singleslice and multi-slice, and 3D volume images. The Signa HFO/i MR System is an open style magnet operating at 0.7T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and shorter scan times than the Signa Profile System.
The provided text describes a 510(k) submission for the GE Signa HFO/i Magnetic Resonance System. However, it does not contain specific acceptance criteria or an explicit study proving the device meets those criteria in the way generally expected for an AI/ML device submission.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices (Signa Horizon CX and Signa Profile Magnetic Resonance Systems) for a new MRI system. The criteria for substantial equivalence are different from performance metrics for an AI/ML diagnostic device.
Here's a breakdown of what is and is not present in the provided text, in relation to your requested information template:
Information Not Present (Typical for AI/ML Device Submissions, but not relevant for this MRI system's 510(k))
- Acceptance Criteria Table: There are no reported performance metrics like sensitivity, specificity, AUC, or other quantitative measures for diagnosing conditions. The document states the system provides "higher resolution imaging and shorter scan times" and that "images provide information that can be useful in determining a diagnosis" when interpreted by a trained physician, but no numerical targets or outcomes are presented.
- Sample size for the test set and data provenance: No data from patient studies or image sets are described for evaluating diagnostic performance.
- Number of experts used to establish ground truth & qualifications: N/A, as no diagnostic performance study is detailed.
- Adjudication method: N/A.
- Multi-reader multi-case (MRMC) comparative effectiveness study: N/A. The document states the system "can be useful in determining a diagnosis" when interpreted by a "trained physician," implying human interpretation, but no study comparing human performance with/without the device is described.
- Standalone (algorithm only) performance: N/A, as this is an MRI hardware system, not an AI algorithm.
- Type of ground truth used: N/A.
- Sample size for the training set: N/A.
- How the ground truth for the training set was established: N/A.
What the Document Does Describe Regarding "Proving" Safety and Effectiveness:
The "proof" in this context is based on substantial equivalence to existing legally marketed devices.
- Predicate Devices: The Signa HFO/i is compared to the Signa Horizon CX and Signa Profile Magnetic Resonance Systems.
- Key Differences: The main difference is the Signa HFO/i uses a 0.7T Open Magnet, compared to the Signa Horizon's typical 1.0T cylindrical magnet and the Signa Profile's 0.2T permanent magnet.
- Performance Claims: The HFO/i system supports "improved higher resolution imaging and shorter scan times" compared to the Signa Profile System (which operates at a lower field strength).
- Standards Compliance: "The Signa HFO/i Magnetic Resonance System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis." This is the primary method of "proving" the device meets safety and performance expectations for an MRI system, not for an AI algorithm's diagnostic performance.
- Indications for Use: The indications for use are consistent with those of currently marketed MRI systems, stating it's a diagnostic imaging device for various body systems. It also mentions its "open" design allows for use during interventional procedures with MR compatible devices.
- Conclusion of Substantial Equivalence: GE concludes the device is substantially equivalent, noting "The Signa HFO/i Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards." The FDA concurred with this assessment in their response letter.
In summary, the provided document details a 510(k) submission for an MRI hardware system. The "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to predicate devices and compliance with relevant safety and performance standards for MRI equipment, rather than a diagnostic performance study for an AI/ML algorithm.
§ 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.