(182 days)
The ECHELON Oval MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR 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 diagnosis determination.
The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
The provided text is a 510(k) summary for the ECHELON OVAL V6.0A MRI system, which is a software update to an existing MRI system. The document states that "The ECHELON OVAL V6.0A MRI System is only a software update with new and improved features." This implies that the core hardware and fundamental MRI functionalities (such as image acquisition, magnet strength, etc.) remain as per the predicate device (ECHELON OVAL V5.1 MRI System, K153547).
The performance evaluation primarily focuses on the new and improved software features rather than establishing a new acceptance criteria for the entire MRI system from scratch. The acceptance criteria essentially revolve around demonstrating that these new and improved features perform as intended and produce diagnostically acceptable images.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| New Features Performance | Each new feature (Computed DWI HiMAR, QSM) performs as intended for diagnostic use. | "Test data confirmed that each new and improved feature perform as intended for diagnostic use." |
| Improved Features Performance | Each improved feature (Soft Sound Package, R2* Map Analysis, Advanced contrast enhanced abdominal imaging, ASL-Perfusion (GRASE), Cine-PC Analysis) performs as intended for diagnostic use. | "Test data confirmed that each new and improved feature perform as intended for diagnostic use." |
| Clinical Image Quality for New/Improved Features | Clinical images from applicable new and improved features have acceptable image quality for clinical use. | "Clinical image examples are provided for each applicable new and improved feature and that we judged to be sufficient to evaluate clinical usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use." |
| Overall Substantial Equivalence | The ECHELON OVAL V6.0A MRI system is substantially equivalent to the predicate device (ECHELON Oval V5.1 MRI System (K153547)) in terms of hardware, base elements of software, safety, effectiveness, and functionality. | This is the overall conclusion of the 510(k) submission, based on the rationale that hardware and coil differences are not significant, and functionality enhancements do not constitute a new intended use or raise different questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the numerical sample size for the test set. It mentions "Clinical image examples are provided for each applicable new and improved feature." The provenance of the data (country of origin, retrospective or prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Number of experts: Singular ("a radiologist").
Qualifications of experts: Only "a radiologist" is mentioned. No specific experience level (e.g., 10 years of experience) is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No formal adjudication method (like 2+1 or 3+1) is described. The text states: "a radiologist validated that the clinical images have acceptable image quality for clinical use." This implies a single expert review for validation.
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 such study (MRMC comparative effectiveness study with AI assistance) is mentioned or implied. The device is purely an MRI system software update, not an AI-powered diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of this device. The device is a Magnetic Resonance Imaging System, designed to produce images for interpretation by a trained physician. It's not an an algorithm performing a standalone diagnostic task without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the test set, specifically for the clinical image quality, appears to be based on expert opinion/validation by a radiologist. The document doesn't mention pathology, outcomes data, or a formal expert consensus process.
8. The sample size for the training set
The document does not mention a "training set" or its sample size. This is consistent with a software update for an MRI system, where the focus is on verifying the performance of new/improved features rather than an AI/ML algorithm that undergoes a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned in the context of this device's evaluation.
§ 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.