(36 days)
The OASIS MR 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 OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting open magnet in an open gantry design was based on the ECHELON MRI system. The OASIS has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
The provided text does not contain information related to specific acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics, clinical trials, or comparative effectiveness studies.
Instead, this document is a 510(k) premarket notification for a Magnetic Resonance Imaging (MRI) system. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated study.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for a 510(k) are implicitly met by demonstrating substantial equivalence to a predicate device, which means having the same intended use, similar technological characteristics, and safety and effectiveness that are at least as good as the predicate.
- Reported Device Performance: Not reported in quantitative performance metrics. The document states:
- "MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation." (General statement, not specific performance.)
- "The technological characteristics of this device are similar to the primary predicate device. The primary difference is the 1.2 Tesla superconducting open magnet. The control and image processing hardware and the base elements of the system software are identical to the predicate device." (Focuses on similarity to predicate, not explicit performance.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No specific test set or associated data is mentioned for performance evaluation. This submission relies on demonstrating similarity to a predicate device.
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)
- Not applicable / Not provided. No test set requiring expert ground truth is described. The "ground truth" for this submission is established by the accepted performance and safety of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication process is described.
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. An MRMC study was not done. This device is an MRI system itself, not an AI-assisted diagnostic tool for readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is an MRI system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Implicitly the established safety and effectiveness of the predicate device. The "ground truth" for this application is that the predicate device (ECHELON Magnetic Resonance Imaging System, K052172) is considered safe and effective for its intended use, and the new device is substantially equivalent.
8. The sample size for the training set
- Not applicable / Not provided. There is no mention of a training set for an algorithm or model.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set is discussed.
In summary: This 510(k) submission for the OASIS MRI system is a "substantial equivalence" claim. It does not present a study with explicit acceptance criteria, performance metrics, or data from a test set as would be found for a novel diagnostic algorithm or software. Its acceptance is based on demonstrating that it is as safe and effective as a previously cleared device with similar intended use and technological characteristics.
§ 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.