(100 days)
The EPI-II System Option with High Performance Gradients is designed to provide higher gradient output power in order to allow the user to acquire images at a faster rate or acquire images with a higher spatial resolution than would normally be possible with a standard EDGE system with the EPI-I software option. The indications for use are the same as for standard MR imaging.
The Picker International EDGE system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The EPI-II System Option with High Performance Gradients consists of water-cooled non-resonant self-shielded gradient coils, high performance gradient amplifiers, single-shot echo-planar sequences, and modified standard sequences.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the EPI-II System Option as having higher performance capabilities compared to a predicate device (standard EDGE system with EPI-I software) rather than presenting explicit "acceptance criteria" against which a direct performance measurement is assessed. The safety and effectiveness sections outline how the EPI-II system improves upon the previous version.
| Feature/Parameter | Acceptance Criteria (Implied/Predicate Performance) | Reported Device Performance (EPI-II) |
|---|---|---|
| Total dB/dt (Time Varying Magnetic Field) | Not to exceed 20 T/s (IEC 601-2-33 method) | Software warns >40 T/s, prohibits >60 T/s (FDA guidance) |
| SAR Algorithm | Limited to specific W/kg for Normal, First, Second Level | Same as predicate (limits power deposition) |
| Acoustic Noise (Worst Case, Average) | 118.7 dBA (Standard EDGE system) | 109.1 dBA |
| Acoustic Noise (Worst Case, Peak) | 127.8 dB (Standard EDGE system) | 119.5 dB |
| Gradient Amplifiers | 135 A RMS, 220 A peak, 350 V max. (Predicate K931544) | 270 A RMS, 440 A peak, 600 V max. |
| Max Gradient Strength | 16 mT/m (Predicate) | 27 mT/m |
| Max Slew Rate | 25 mT/m/msec (Predicate) | 72 mT/m/msec |
| Fast Scanning Sequences | Multi-Shot EPI (Predicate K945828) | Single-shot EPI |
| EPI Data Correction | Automated process (Predicate K945828) | Interactive prescan process |
| Standard Imaging Sequences | Lower output power limits resolution, inter-echo spacing, etc. | Increased image resolution or redesigned for shorter inter-echo spacing, shorter echo times, and/or increased motion artifact suppression |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain any information about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This device is an MRI system option, and the "effectiveness" section focuses on hardware and software upgrades enabling faster imaging and higher spatial resolution, not a diagnostic algorithm evaluated on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
As there is no mention of a test set or ground truth in the context of patient data/diagnoses, there is no information about experts or their qualifications for establishing such ground truth. The effectiveness claims are based on technical specifications and functional improvements of the MRI system itself.
4. Adjudication Method for the Test Set
Since no test set evaluating a diagnostic outcome is described, there is no information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on improvements in scanner capabilities (speed, resolution) rather than the diagnostic interpretive performance of human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This document describes an MRI system option, not a standalone algorithm for diagnostic interpretation. Therefore, no standalone algorithm performance study is described. The "EPI Data Correction" for the EPI-II is described as an "Interactive prescan process," implying human involvement, while the predicate was automated.
7. Type of Ground Truth Used
The "ground truth" implicitly used for the effectiveness claims of this MRI system option is based on engineering specifications and measurements of physical parameters (e.g., gradient strength, slew rate, acoustic noise, imaging speed, spatial resolution) directly related to the hardware and software capabilities. It is not related to clinical outcomes, pathology, or expert consensus on diagnostic images in the way a diagnostic AI would be evaluated.
8. Sample Size for the Training Set
As this document describes an MRI system's hardware and software capabilities rather than a machine learning algorithm requiring a "training set" of data, the concept of a training set sample size is not applicable and is not mentioned.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, since there is no mention of a training set, how its "ground truth" was established is not applicable and is not discussed.
§ 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.