(38 days)
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2.5-series are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
In addition the Achieva, Intera and Panorama 1.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2.5-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA 1.0T release 2-series. The Release 2.5-series introduces the new functionalities:
- Cardiac MR Functional Analysis
- 4D-THRIVE
- Prospective Motion Correction
- Propeller
- CMR Prepulse Imaging.
- CMR IR-TFE T1 Imaging
- Cardiac MR Reporting
- Rapid Focus
- Rapid Locus
- Interventional procedures
- Achieva 3.0T mobile
This 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. The document describes a new release (Release 2.5) of existing Magnetic Resonance Diagnostic Devices (MRDDs) – ACHIEVA, INTERA, and PANORAMA 1.0T. The submission focuses on describing new functionalities added to the previous versions and declares substantial equivalence to the predicate devices.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
* Not provided. The document describes new features and functionalities but does not list specific quantitative acceptance criteria or performance metrics for these new features. The focus is on substantial equivalence to predicate devices, implying that the established safety and effectiveness of the previous versions are maintained.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not provided. There is no mention of a specific test set, its sample size, or data provenance.
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 provided. No information regarding expert involvement in establishing ground truth for any test set is given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not provided. No adjudication method is mentioned as a test set itself is not detailed.
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, or at least not described. The device is a Magnetic Resonance Diagnostic Device, and the new features are primarily related to image acquisition, processing, and analysis tools (e.g., Cardiac MR Functional Analysis, 4D-THRIVE, Prospective Motion Correction, Rapid Focus). While these tools might assist human readers, the document does not present them as a standalone AI for diagnosis nor does it provide an MRMC study comparing human performance with and without these tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not explicitly described as a standalone study in the traditional sense of an AI algorithm. The functionalities described (e.g., automatic segmentation, quantitative measurements) are components of the MR system and image analysis software, intended to be used by a "trained physician." There is no indication of a standalone performance evaluation of these components independent of human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not provided. No ground truth type is mentioned as no specific study with ground truth establishment is detailed.
8. The sample size for the training set:
* Not applicable / Not provided. The device is a medical imaging system with new software features. There is no mention of a 'training set' in the context of an AI/ML algorithm being trained, as understood by modern submissions. The development process would have involved engineering and validation, but not typically a "training set" for artificial intelligence or machine learning as such.
9. How the ground truth for the training set was established:
* Not applicable / Not provided. As no training set is mentioned, its ground truth establishment is also not described.
Summary of what is present:
The document primarily serves as a 510(k) summary for a new release of an existing device, focusing on substantial equivalence. It highlights new functionalities and capabilities added to the MR system but does not provide detailed performance metrics, clinical study results, or validation data for these new features in the way a submission for a novel diagnostic algorithm might. The implicit assumption is that the safety and effectiveness of the overall MR system remain equivalent to the predicate devices, and the new features enhance capabilities within that established framework.
§ 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.