(28 days)
Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremittes. 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 MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
The subject device, MAGNETOM Amira with syngo MR E11S, is a modification of the previously cleared predicate device, MAGNETOM Amira with syngo MR E11N (K152283). Software version syngo E11S for MAGNETOM Amira includes software applications migrated from the previously cleared MAGNETOM Aera systems with syngo MR E11C and E11C - AP02 (K153343 and K163312). Only minor adaptations were needed to support the system specific hardware and optimize the sequence/protocols. The following are the software applications migrated from previously cleared software to the subject device:
- . fast TSE
- o Improvements in BLADE Imaging
- SMS EPI .
- o Simultaneous Multi Slice Imaging
- Quiet DWI .
- o Noise reduced sequence for diffusion weighted imaging
- GOBrain ●
- o Supports brain examination in short acquisition time
- GOBrain+ ●
- o GOBrain adaptation to support protocols developed for contrast enhanced imaging of the brain
Listed below are the hardware updates to the MAGNETOM Amira with syngo MR E11S:
- Updated MRAWP/MRWP (Syngo Acquisition Workplace/ Syngo Workplace) . based on the new host platform-HP Z440.
- Endorectal interface and adapter to connect the Endorectal Coil (to be ordered . separately) to the MAGNETOM Amira systems.
The MAGNETOM Amira with software version syngo MR E11S will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Amira systems.
This document describes the MAGNETOM Amira with software syngo MR E11S device. Based on the provided text, the device is a modification of a previously cleared Magnetic Resonance Diagnostic Device (MRDD) and no new acceptance criteria or new studies were performed to prove the device meets acceptance criteria. Instead, the manufacturer argues for substantial equivalence to existing predicate devices.
Here's an analysis based on the information provided and what can be inferred about the "acceptance criteria" through the lens of substantial equivalence for this type of device:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria (e.g., in terms of sensitivity/specificity/accuracy) or quantitative performance metrics for the MAGNETOM Amira with software syngo MR E11S.
The "acceptance criteria" for this device, being a modification of an existing MRDD, are implicitly tied to demonstrating that it performs as intended and is as safe and effective as its predicate devices. This is shown through verification and validation activities (non-clinical performance testing) and by confirming that the technological characteristics and indications for use are substantially equivalent to cleared devices.
The reported device performance is that it "performs as intended" and demonstrates "equivalent safety and performance profile" as the predicate device.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with relevant safety standards (e.g., IEC 60601-1), risk management. | Adheres to recognized and established industry practices and standards (IEC 60601-1 series, ISO 14971), features bear "equivalent safety profile". |
| Effectiveness/Performance | Device produces images and/or spectra and physical parameters that assist in diagnosis, similar to predicate. | "Performs as intended" by producing MR images/spectra necessary for diagnosis. "Equivalent performance profile" to predicate. Sample clinical images provided. |
| Software Functionality | Software functions as designed, adheres to software lifecycle processes standard (IEC 62304). | Software verification and validation testing completed. Software applications are "migrated from previously cleared software," with "minor adaptations." |
| Hardware Functionality | Hardware interfaces and components function correctly. | Hardware updates (MRAWP/MRWP, Endorectal interface) tested, no new questions of safety or effectiveness. |
| Indications for Use | Indications for use are the same as the predicate device. | Indications for use are "the same as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions that "sample clinical images were taken for the endorectal coil." It does not specify the number of images or cases.
- Data Provenance: The document does not specify the country of origin of these "sample clinical images" or whether they were retrospectively or prospectively collected.
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)
This information is not provided in the document. Given that no clinical studies were performed to establish new performance metrics, it's unlikely that a formal ground truth establishment process involving multiple experts for a test set was undertaken for this substantial equivalence submission. The interpretation of images for diagnosis as mentioned in the Indications for Use is "by a trained physician," but this pertains to the general use of the device, not specific to establishing ground truth for a new performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 MRMC comparative effectiveness study was done, as stated: "No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device." This device is a Magnetic Resonance Diagnostic Device, and the document doesn't indicate it incorporates AI for interpretation or assistance, thus the question of human reader improvement with AI is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an MR system, a hardware and software diagnostic device for image acquisition and display. It is not an algorithm-only standalone diagnostic tool, and therefore, standalone algorithmic performance in the context of AI is not relevant or evaluated here. The performance is of the entire MR system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that "No clinical tests were conducted," and the primary evaluation was for substantial equivalence through non-clinical performance testing and software verification/validation, a formal "ground truth" as typically established for new diagnostic accuracy claims (e.g., pathology-confirmed cases) was not used for this submission. The "sample clinical images" would likely have been used to subjectively confirm expected image quality and functionality, rather than for a quantitative ground truth comparison.
8. The sample size for the training set
This device is an MR diagnostic system, not an AI model that requires a distinct training set. The software updates are "migrated from previously cleared software," implying reuse and adaptation of existing, validated code and functionalities. Therefore, the concept of a "training set" in the context of machine learning does not apply here.
9. How the ground truth for the training set was established
As the concept of a training set for an AI model is not applicable to this device as described, the establishment of ground truth for a training set is not relevant.
§ 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.