(17 days)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/ or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
Your MAGNETOM system 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 mobile configuration for MAGNETOM scanners enables customers to relocate the MRI System to different locations and therefore provide imaging services to hospitals or locations where fixed installations are not possible or feasible.
For MAGNETOM Aera a mobile configuration is already available on the market with a fixed patient table. Within this premarket notification the Tim Dockable Table is being made available for the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR Tim Dockable Table as an extension to their MRI fleet.
In order to support the addition of the Tim Dockable Table a hardware modification is necessary. A support bracket will be modified to secure the Tim Dockable Table during repositioning of the Trailer. For this modifications for the trailer manufacturers, which need to underqo certification, are adapted.
The MAGNETOM Aera - Mobile Solution with Tim Dockable Table described within this submission does not contain any software modifications.
- Workflow Release of Tim Dockable Table to the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR table as an extension to their MRI fleet
- Modification of an existing support bracket to secure the Tim Dockable Hardware Table during repositioning of the Trailer
- The MAGNETOM Aera Mobile Solution with Tim Dockable Table Software described within this submission does not contain any software modification compared to the predicate device.
The provided text describes a 510(k) submission for a device called "MAGNETOM Aera - Mobile Solution with Tim Dockable Table." However, it is not an AI/ML medical device submission. This submission is for a hardware modification to an existing Magnetic Resonance Diagnostic Device (MRDD). The key modification is the addition of a "Tim Dockable Table" to a mobile MRI unit and a complementary support bracket to secure it during transport.
Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML medical device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
- Details on sample sizes for test sets, data provenance, or ground truth establishment for AI/ML.
- Information on expert reviewers, adjudication methods, or MRMC studies.
- Mention of standalone algorithm performance or training set details for an AI/ML model.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (MAGNETOM Aera with syngo MR E11C-AP01) through:
- Nonclinical Tests: General Performance Testing, Acoustic Noise Testing, and Environmental Testing (Weather Influences).
- Safety and Effectiveness: Compliance with standards like ISO 14971 (risk management), IEC 60601-1 series (electrical/mechanical risk), IEC 62304 (software development, though it explicitly states no software modifications), and NEMA DICOM standards.
The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device." and "The MAGNETOM Aera - Mobile Solution with Tim Dockable Table described within this submission does not contain any software modifications." It goes on to clarify this again: "The MAGNETOM Aera Mobile Solution with Tim Dockable Table Software described within this submission does not contain any software modification compared to the predicate device."
Since this is a submission for a hardware modification to a conventional medical device, and not an AI/ML device, the requested information cannot be extracted from this document.
§ 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.