(234 days)
The Siemens Interactive MR Localizer is indicated for use as a navigation system. The Interactive THE Localizer performs interactive slice positioning with a pointing instrument for planning and control of interventional and interoperative procedures. The system comprises of a stereoscopic camera, a sterilizable pointing device, a calibration phantom, and an Interactive MR (IMR) software.
The Interactive MR Localizer is a navigation system for the MAGNETOM Open and Open viva System.
The provided text is a 510(k) summary for the "Interactive MR Localizer" device, intended for use with MAGNETOM Open and Open viva Systems. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way one might find for a novel diagnostic algorithm.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not explicitly mentioned in this document. The document primarily addresses the safety and effectiveness from the perspective of substantial equivalence to existing MR systems, stating that the modifications described do not raise new questions.
Here's an analysis of what information can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as per document) |
|---|---|
| Max Static Field Action Level | Unaffected by modifications |
| Rate of Change of Magnetic Field Action Level | Unaffected by modifications |
| RF Power Deposition Action Level | Unaffected by modifications |
| Acoustic Noise Levels Action Level | Unaffected by modifications |
| Specification Volume Performance Level | Unaffected by modifications |
| Signal to Noise Performance Level | Unaffected by modifications |
| Image Uniformity Performance Level | Unaffected by modifications |
| Geometric Distortion Performance Level | Unaffected by modifications |
| Slice Profile, Thickness, and Gap Performance Level | Unaffected by modifications |
| High Contrast Spatial Resolution Performance Level | Unaffected by modifications |
| Overall Goal: Substantial Equivalence | Achieved through laboratory testing |
Note: The document states these parameters are "unaffected by the modifications described within this notification," implying they meet the established performance levels for the base MAGNETOM Open and Open viva System.
2. Sample Size Used for the Test Set and Data Provenance:
- Not specified. The document mentions "laboratory testing" but does not provide any details about the size or characteristics of any test set used.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable/Not specified. The nature of "laboratory testing" for substantial equivalence of an MR localizer does not typically involve expert review in the same way an AI diagnostic algorithm would. The testing likely focused on physical and technical performance specifications rather than clinical diagnostic accuracy against a ground truth established by experts.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. Given the type of device and the nature of the stated "laboratory testing," expert adjudication for a test set is not explicitly mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not mention any MRMC study comparing human readers with and without AI assistance. This device is a navigation system, not a diagnostic AI algorithm intended to assist human interpretation of images.
6. Standalone Performance Study (Algorithm only):
- Partially applicable, but for hardware/software integration, not a diagnostic algorithm. The "laboratory testing" mentioned supports the claim that the "technological differences do not raise any new questions pertaining to safety and effectiveness" for the integrated system. This implies a form of standalone testing for the Interactive MR Localizer's functionality within the MAGNETOM system, but it's not a standalone diagnostic algorithm performance as might be expected for an AI device. No specific metrics for "algorithm only" performance are provided beyond the statement of "unaffected" performance metrics for the overall MR system.
7. Type of Ground Truth Used:
- Not explicitly specified in the context of diagnostic accuracy. For the performance levels mentioned (e.g., Signal to Noise, Geometric Distortion), the ground truth would likely be established through physical measurements using phantoms, calibrated instruments, and established engineering standards, rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
- Not applicable/Not specified. This device is described as a "navigation system" and not a machine learning or AI algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified. As there is no mention of a training set, the establishment of its ground truth is not discussed.
In summary: This 510(k) submission focuses on demonstrating that the "Interactive MR Localizer" is substantially equivalent to existing MR systems and that its integration does not negatively impact the established safety and performance parameters of the core MR device. It does not contain the detailed study results, acceptance criteria for diagnostic accuracy, or AI-specific validation metrics that would be expected for an AI-powered diagnostic device. The "acceptance criteria" presented are essentially that the modified MR system maintains the performance and safety characteristics of the predicate device across various physical and imaging parameters.
§ 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.