(80 days)
The Altaire 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 ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry design. The design was based on the AIRIS II Open MRI system. The ALTAIRE has been designed to enhance clinical utility as compared to the AIRIS II by taking advantage of the imaging properties of the 0.7T magnet.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the ALTAIRE Magnetic Resonance Imaging System, presented in the requested format.
Important Note: The provided document is a 510(k) summary for a medical device cleared in 2002. At that time, the regulatory requirements for performance studies, particularly concerning detailed acceptance criteria and standalone AI performance, were significantly different and generally less stringent than for modern AI/ML medical devices. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than comprehensive performance studies as might be expected for novel AI tools today. Therefore, much of the requested information (like specific acceptance criteria, detailed study design for proving performance, expert adjudication, MRMC studies, or standalone algorithm performance) is not present in this type of submission.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Intended Use: Provide physiological and clinical information, obtained non-invasively and without ionizing radiation, for diagnosis determination by a trained physician. Produce transverse, coronal, sagittal, oblique, and curved cross-sectional images displaying internal structure of head, body, or extremities. Images reflect spatial distribution of protons exhibiting magnetic resonance (proton density, T1, T2, flow). | The ALTAIRE MR system functions as an imaging device, utilizing a 0.7 Tesla superconducting magnet. It produces images based on proton density, T1, T2, and flow, consistent with the scientific principles of MRI. The device's 'physical and performance characteristics' are generally described as being 'capable of producing high quality anatomical images'. |
| Substantial Equivalence: To Hitachi AIRIS II MRI System (K001334) and GE Signa OpenSpeed MRI System (K992746). | The submission concludes that the ALTAIRE MRI system is "substantially equivalent to the listed predicate device." The intended use is stated as "identical to the listed predicate device." The design was based on the AIRIS II, and the primary difference is "software enhancements." |
| Technological Characteristics: Similar to the primary predicate device, with inclusion of software enhancements. | The control and image processing hardware and base elements of the operating system software are identical to the primary predicate device. The software enhancements enhance clinical utility compared to the AIRIS II by taking advantage of the 0.7T magnet. |
| Safety: Implied by substantial equivalence to legally marketed devices. | Not explicitly stated as a performance metric, but substantial equivalence implies safety comparable to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document does not describe a traditional "test set" or a performance study in the context of clinical accuracy or diagnostic performance involving a specific sample size of patients or images. The evaluation is centered on demonstrating substantial equivalence based on technical specifications and intended use.
- Data Provenance: Not applicable. No specific clinical data from a test set is referenced for the comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment from experts for a dedicated test set is described. The evaluation is not based on direct clinical performance comparison of the new device's images against a ground truth dataset established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no described test set or adjudication process for diagnostic interpretations.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an MRI system, not an AI interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study in the context of an algorithm's diagnostic output was not done. The device is a diagnostic imaging system that requires human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No specific ground truth for diagnostic accuracy is described in relation to a performance study for this device. The "ground truth" for substantial equivalence is the demonstration that its technical characteristics and intended use are similar to predicate devices.
8. The sample size for the training set
- Not applicable. The document does not describe a "training set" in the context of machine learning. The device being submitted is an MRI system, not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there's no described training set related to AI/ML, there's no mention of ground truth establishment for it.
§ 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.