(84 days)
The ECHELON Synergy 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, spinlattice relaxation time (TI), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses:
- · TI, T2, proton density weighted imaging
- · Diffusion weighted imaging
- · MR Angiography
- · Image processing
- · Spectroscopy
- · Whole Body
The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design.
The provided document is a 510(k) summary for the FUJIFILM Healthcare Corporation's ECHELON Synergy MRI System. This document asserts substantial equivalence to a predicate device and primarily focuses on technical characteristics and adherence to standards rather than detailed performance studies with acceptance criteria for a diagnostic aid.
Here's an analysis of the acceptance criteria and study information derived from the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's a 510(k) submission for an MRI system with an added coil, not a diagnostic algorithm. The acceptance criteria for the added Breast Coil 17 are implicitly tied to the performance and safety standards of the predicate device (ECHELON Synergy V10.0 K233687).
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| The new feature (Breast Coil 17) performs as intended for diagnostic use and maintains safety and effectiveness equivalent to the predicate device. | "Performance bench testing was conducted on the applicable new feature. Test data confirmed that new feature perform as intended for diagnostic use." |
| "Clinical image examples are provided for applicable new 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." | |
| No significant changes in technological characteristics compared to the predicate device, especially regarding safety (gradient system and RF system controls, pulse sequences). | "Added coil doesn't constitute a new intended use. There are no significant changes in technological characteristics. For safety, gradient system and RF system is controlled according to same regulation as ECHELON Synergy V10.0 (K233687)." |
| "There are no differences regarding hardware units." | |
| "There are no differences regarding software functionality." | |
| Conformance with applicable medical device safety and performance standards (e.g., IEC 60601 series, NEMA MS series). | The device was "subjected to the following laboratory testing" (listed IEC and NEMA standards) and is "in conformance with the applicable parts of the following standards." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated as a number of cases or patients. The document mentions "Clinical image examples."
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It only states that "Clinical images were collected and analyzed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: One radiologist.
- Qualifications of experts: A "radiologist" validated the clinical images. No further details on experience level are provided.
4. Adjudication method for the test set:
- Adjudication method: None mentioned beyond a single radiologist's validation of image quality for clinical use.
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:
- MRMC study: No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. This submission is for an MRI system with an added coil, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Not applicable. This device is an MRI system, not a standalone AI algorithm. The performance evaluation focused on the technical aspects and image quality of the MRI machine and its new coil.
7. The type of ground truth used:
- Type of ground truth: Expert opinion (a single radiologist's validation of "acceptable image quality for clinical use"). This is tied to the demonstrative aspect of clinical image examples, rather than a definitive diagnostic truth for a disease state.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This document is about a hardware modification (an added coil) to an existing MRI system. It does not involve machine learning models that require training sets in the conventional sense.
9. How the ground truth for the training set was established:
- How ground truth for training set was established: Not applicable, as there is no mention of a training set or machine learning model.
§ 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.