(78 days)
The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation times (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning. The Gyrex Esteem 1.5T MRI System is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis. surgery planning, or therapy planning and is used in a clinic or hospital setting. The SW Version 5.0 upgrade does not change or contain any additional indications for use.
The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation times (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning. The major components changed or updated over that described in the predicate device submission are: A higher performance gradient amplifier and a water-cooled gradient that when utilized together provide a peak strength of 29mT/M and a slew rate of 60mT/M/msec, An ECG monitoring unit to allow pulse sequences gated to the cardiac cvcle to provide cardiac and pulmonary images with reduced artifact from heart motion, The addition of a phased array spine RF coil for increased FOV coverage in the z-direction, Additional flexibility added to existing user interface software.
Here's an analysis of the provided text regarding acceptance criteria and a device study:
Important Note: The provided documents are a 510(k) submission summary and an FDA clearance letter for a software upgrade to an MRI system. These documents primarily focus on demonstrating substantial equivalence to a predicate device and do not typically contain detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or MRMC studies in the way a clinical trial for a novel AI device would.
Based on the information provided, it's not possible to fully answer all aspects of your request as the document doesn't contain the level of detail typically found in a clinical study report for performance metrics. However, I will extract and infer what I can.
Acceptance Criteria and Study Details from Provided Documents
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the provided documents do not contain a table of explicit, quantitative performance acceptance criteria with corresponding reported performance for the device. The implicit acceptance criterion for a 510(k) submission is that the modified device remains substantially equivalent to its predicate device in terms of safety and effectiveness, and that its indications for use remain unchanged.
The document indicates:
- The software upgrade (Version 5.0) for the Elscint Gyrex Esteem 1.5T MRI System.
- The hardware changes (higher performance gradient amplifier, water-cooled gradient, ECG monitoring unit, phased array spine RF coil) are improvements to the existing system.
- The software update provides "Additional flexibility added to existing user interface software."
- "The SW Version 5.0 upgrade does not change or contain any additional indications for use."
Therefore, the performance is assumed to be at least as good as, if not better than (due to hardware improvements), the predicate device, within the same indications for use. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided or defined as acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided documents do not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary for a software upgrade to an existing MRI system where the primary goal is to show equivalence, not clinical performance for a new diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided documents do not mention any experts used to establish ground truth for a test set. This is consistent with the type of submission, which focuses on hardware/software updates to an existing system, not a new interpretive algorithm.
4. Adjudication Method for the Test Set
The provided documents do not mention any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided documents do not indicate that an MRMC comparative effectiveness study was done. The submission is for a device upgrade, not a new diagnostic tool requiring a comparison of human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only)
The provided documents do not describe a standalone performance study. The device is an MRI system and its software, which acquires images for interpretation by a trained physician, not an AI algorithm that performs standalone diagnosis.
7. Type of Ground Truth Used
The provided documents do not specify any type of ground truth used for performance evaluation. The "ground truth" concept is not directly applicable in the context of this 510(k) submission, which focuses on the technical specifications and safety/effectiveness of the MRI system itself rather than the diagnostic accuracy of a specific interpretation (which is handled by a trained physician). The "ground truth" for an MRI system's performance would be its ability to produce clinically useful images that, "when interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning."
8. Sample Size for the Training Set
The provided documents do not mention a training set sample size. This is understandable as the submission is for an MRI system's software update, not a machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
The provided documents do not mention how ground truth for a training set was established, as this concept is not applicable to the information contained within these documents.
Summary of Device and 510(k) Approach:
The provided documents detail a 510(k) submission for a software (Version 5.0) and hardware upgrade to an existing Elscint Gyrex Esteem 1.5T MRI System. The key changes are:
- Higher performance gradient amplifier and water-cooled gradient (29mT/M peak strength, 60mT/M/msec slew rate).
- ECG monitoring unit for cardiac/pulmonary imaging.
- Phased array spine RF coil for increased FOV.
- Additional flexibility in user interface software.
The regulatory strategy for this submission is substantial equivalence to the predicate device (Elscint Gyrex Esteem 1.5T MRI System, prior to upgrade). The core assertion is that these modifications do not change the indications for use and that the device remains safe and effective for its stated purpose: producing cross-sectional images for diagnostic, surgery planning, or therapy planning purposes, to be interpreted by a trained physician.
Therefore, the "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate device, ensuring the modifications do not introduce new risks or diminish performance. No detailed clinical performance study with specific metrics, ground truth, or expert evaluation is presented because the device itself is not a diagnostic algorithm, but rather an imaging system whose output is interpreted by a human expert.
§ 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.