(79 days)
The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM C! may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles
The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission outlines performance levels that the MAGNETOM C! system will conform to, largely by referencing NEMA and IEC standards for established MRI safety and performance parameters. It states that the device "will conform" to these standards, implying that meeting these standards serves as the acceptance criteria. However, explicit numerical performance metrics for the MAGNETOM C! are not provided in the summary. Instead, it relies on substantial equivalence to predicate devices (MAGNETOM 0.2 T Concerto and MAGNETOM 1.0 T Harmony) that presumably already meet these standards.
| Acceptance Criteria (Performance Levels) | Reported Device Performance (MAGNETOM C!) | Notes |
|---|---|---|
| Maximum Static Field | Conforms to FDA-recognized NEMA Standards and international IEC standard for safety. | No specific value given for MAGNETOM C! (likely 0.2T based on predicate). Assumed to be similar to predicate, which is 0.2T for Concerto or 1.0T for Harmony. |
| Rate of Change of Magnetic Field | Conforms to FDA-recognized NEMA Standards and international IEC standard for safety. | No specific value given. |
| RF Power Deposition | Conforms to FDA-recognized NEMA Standards and international IEC standard for safety. | No specific value given. |
| Acoustic Noise Levels | Conforms to FDA-recognized NEMA Standards and international IEC standard for safety. | No specific value given. |
| Specification Volume | Conforms to FDA-recognized NEMA Standards for measurement of performance. | No specific value given. |
| Signal to Noise | Conforms to FDA-recognized NEMA Standards for measurement of performance. | No specific value given. |
| Image Uniformity | Conforms to FDA-recognized NEMA Standards for measurement of performance. | No specific value given. |
| Geometric Distortion | Conforms to FDA-recognized NEMA Standards for measurement of performance. | No specific value given. |
| Slice Profile, Thickness and Gap | Conforms to FDA-recognized NEMA Standards for measurement of performance. | No specific value given. |
| High Contrast Spatial Resolution | Conforms to FDA-recognized NEMA Standards for measurement of performance. | No specific value given. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a specific clinical test set or data provenance for the MAGNETOM C! device. The submission relies on demonstrating substantial equivalence to existing cleared devices (Siemens MAGNETOM 0.2 T Concerto and Siemens MAGNETOM 1.0 T Harmony) by stating that its operation is "substantially equivalent" and that it "will conform" to established industry standards (NEMA and IEC) for safety and performance. This implies that the standards themselves (NEMA and IEC) are the basis for evaluation, not a new clinical study with a specific patient dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific clinical test set data is described, there is no information provided regarding experts used to establish ground truth. The evaluation is based on technical specifications and conformance to industry standards, not on human interpretation of specific images from a test set.
4. Adjudication Method for the Test Set
As there is no described clinical test set for the MAGNETOM C! in this submission, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned or described in the provided text. The submission focuses on technical performance and substantial equivalence, not on comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The MAGNETOM C! is a diagnostic device (MRI scanner), not an AI algorithm. Therefore, a standalone study for an algorithm's performance is not applicable and not included in this submission. The device itself is the "algorithm" in a sense, as it generates the images, but its performance is measured by its output quality and safety parameters, not by its diagnostic interpretation independent of a human.
7. Type of Ground Truth Used
The "ground truth" in this context is implicitly the established safety and performance metrics defined by FDA-recognized NEMA Standards and international IEC standards for MRI devices. The device's performance is assessed against these technical and safety specifications rather than against clinical outcomes, pathology, or expert consensus on specific patient cases.
8. Sample Size for the Training Set
As this is a submission for an MRI device and not an AI algorithm, the concept of a "training set" in the context of machine learning does not apply to the information provided. The development and testing of an MRI scanner involve engineering and physics principles, not a data-driven training approach.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" as understood in AI/ML, this question is not applicable to the provided information.
§ 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.