(34 days)
The i Open 0.4T system is an open, whole body scanner. It 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 head, body, or extremities. The images produced by the i Open 0.4T system reflect the special 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.
The i Open 0.4T is a 0.4 Tesla permanent MRI system. The magnet is mainly made of Nd-B-Fe material. The system software based on Windows XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing.
This 510(k) submission for the "i Open 0.4T" device does not describe a study involving acceptance criteria for an AI/algorithm's performance.
Instead, this document describes a Magnetic Resonance Imaging (MRI) diagnostic device. The "acceptance criteria" and "device performance" discussed pertain to the technical specifications and physical characteristics of the MRI hardware, rather than the performance of an AI algorithm or software analyzing images.
Therefore, many of the requested fields cannot be filled as they are specific to AI/algorithm performance studies.
Here's a breakdown of what can be extracted from the provided text regarding device performance and comparisons, along with explanations for the missing AI-specific information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance levels that will be evaluated, but it does not provide specific numerical acceptance criteria or reported performance values for these parameters in a tabular format. It states that the device "will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IDC standard for safety issues with Magnetic Resonance Imaging Devices."
| Acceptance Criteria (to be evaluated according to NEMA & IDC Standards) | Reported Device Performance |
|---|---|
| Specification Volume | Not provided in text |
| Signal to Noise | Not provided in text |
| Image Uniformity | Not provided in text |
| Geometric Distortion | Not provided in text |
| Slice Profile, Thickness and Gap | Not provided in text |
| High Contrast Spatial Resolution | Not provided in text |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. This document describes an MRI hardware device, not an AI algorithm evaluated on a dataset. There is no "test set" of patient data for an algorithm's performance described here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. See explanation above. The ground truth for judging an MRI system's image quality would typically be based on established physics principles and phantom measurements, verified by engineers and potentially radiologists interpreting the resulting images for diagnostic utility, but not in the context of an "expert consensus" on an AI's output.
4. Adjudication Method for the Test Set:
- Not applicable. See explanation above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is an MRI hardware device. An MRMC study comparing human readers with and without AI assistance is not described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device itself is the "standalone" imaging equipment. It does not contain a separate AI algorithm being evaluated for standalone performance.
7. The Type of Ground Truth Used:
- For the physical MRI device's performance, the "ground truth" implicitly relies on established engineering and physics principles, standard phantom measurements, and compliance with industry standards (NEMA, IDC) to ensure images produced are accurate representations of the anatomical structures. The document states that "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis," implying that the ultimate diagnostic truth comes from clinical interpretation.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See explanation above.
Summary of the Device's Approval Context:
The "i Open 0.4T" is an MRI system. Its approval is based on demonstrating substantial equivalence to existing legally marketed predicate devices (Hitachi AIRIS II and AIRIS II Version 4.1 Software). This equivalence is established by comparing its technological characteristics, intended use, safety parameters, and general performance levels (e.g., signal-to-noise, image uniformity) to those of the predicate devices and by confirming adherence to recognized standards like NEMA and IDC. The submission focuses on the hardware's ability to produce diagnostic images, not on an algorithm's ability to interpret them.
§ 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.