(192 days)
MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. These images when interpreted by a trained physician yield information that may assist in diagnosis.
MRI SYSTEMS include a series of open permanent magnet MRI system with magnetic field strength of 0.3T, 0.4T and 0.5T respectively. The model number for each of the corresponding system is ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000) respectively. They are composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil. RF Transmission Coil. RF Receiver Coil. Client PC, and Imaging Cabinet. The system software, APEX, based on Windows XP® Professional is an interactive program with user friendly interface.
The provided text is a 510(k) summary for MRI SYSTEMS (ASM-030PIII, ASM-040P, ASM-050P). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics in the way typically required for AI/CADe devices.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific acceptance criteria (e.g., sensitivity, specificity, accuracy) for clinical performance and the device's reported performance against such criteria are not provided. The testing focused on compliance with various engineering and safety standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance | Not specified for clinical performance |
| Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33 | Met all design specifications and complied with standards. |
| Compliance with NEMA MS-1-2008 (SNR) | Met design specifications. |
| Compliance with NEMA MS 2-2008 (Geometric Distortion) | Met design specifications. |
| Compliance with NEMA MS 3-2008 (Image Uniformity) | Met design specifications. |
| Compliance with NEMA MS 5-2003 (Slice Thickness) | Met design specifications. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes non-clinical bench testing for compliance with standards. It does not involve a clinical test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical ground truth was established as this was non-clinical bench testing.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is mentioned.
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
No. This document describes a traditional MRI system, not an AI or CADe device. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical imaging device, not an algorithm being tested in isolation.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was defined by the specifications of the standards (e.g., NEMA standards for SNR, geometric distortion, uniformity, slice thickness). The device's performance was compared against these established technical specifications.
8. The Sample Size for the Training Set
Not applicable. This is a conventional MRI system, not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an algorithm is involved.
§ 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.