(63 days)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 application package AP01, "Implant Suite" for MAGNETOM Aera, enables diagnostic imaging for patients with MR Conditional active and passive implants. Three different Fixed Parameter Options (FPO), Scan Limits 1, 2, and 3, provide conditional implant scan limitations as shown below:
| Fixed Parameter
Options | B1+ peak | B1+ rms | WB SAR | dB/dt
peak | dB/dt rms | Slew rate |
|----------------------------|----------|----------|------------|---------------|-----------|----------------|
| Scan Limits 1 | - | - | ≤ 2 W/kg | - | - | ≤ 200
T/m/s |
| Scan Limits 2 | - | ≤ 2.0 μT | ≤ 0.8 W/kg | - | - | ≤ 200
T/m/s |
| Scan Limits 3 | ≤ 30 μT | ≤ 2.0 μT | ≤ 0.8 W/kg | ≤ 50 T/s | ≤ 56 T/s | ≤ 125
T/m/s |
Without a scan limitation selected, the subject device operates identically to the predicate device. The AP01 application package, "Implant Suite", is an optional feature.
With application package AP01, "Implant Suite" for MAGNETOM Aera, the following changes are introduced:
| Hardware | Modified
Hardware | - Additional segregated control path to safely
switch-off the gradient power in case the limits are
reached during a scan
- Additional supply-voltage supervisions in the
gradient amplifier - Additional measures to ensure permanent active
RF sensor data communication - Additional segregated TX- switch-off path (TSO
box) - New computer hardware for MRAWP and MRWP
due to obsolescence |
|----------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software | New Features
and Applications | - Implant Suite (syngo MR E11C-AP01)
Including: - New Online Patient Safety supervision (OPS)
interface - New safe reaction (switch-off) path for when
implant related limits are exceeded - Extended look-ahead functionality (prediction)
to avoid starting sequences that could
potentially exceed implant-related limits - New internal supervision to detect latent
failures in the control path - New Implant Suite UI (IUI)
- New means to control coil usage
- Adapted pulse sequences with restricted
operation mode |
The provided text describes a 510(k) premarket notification for a medical device, the MAGNETOM Aera with syngo MR E11C-AP01 software, which is a Magnetic Resonance Diagnostic Device (MRDD). The submission aims to demonstrate substantial equivalence to a predicate device (MAGNETOM Aera with syngo MR E11C-AP04 software, K173592).
The core of the submission revolves around the new "Implant Suite" feature, which enables diagnostic imaging for patients with MR Conditional active and passive implants by implementing specific scan limitations.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical performance target format (e.g., sensitivity, specificity, or image quality scores against a baseline). Instead, the acceptance criteria are implicitly defined by the successful verification of the new features and limitations implemented for safe scanning of patients with MR Conditional implants, and the demonstration of equivalent safety and performance to the predicate device.
The reported device performance is therefore described in terms of its ability to implement and adhere to these new limitations and to maintain image quality.
| Acceptance Criteria (Implicit) | Reported Device Performance/Study Findings |
|---|---|
| New Fixed Parameter Options (FPO) and Respective Limitations: The device must correctly implement and enforce the specified B1+ peak, B1+ rms, WB SAR, dB/dt peak, dB/dt rms, and Slew rate limits for different Scan Limits (1, 2, and 3) to ensure safe scanning of MR Conditional implants. | Verification testing of the new Fixed Parameter Options (FPO) and respective limitations: "The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared." (This implies successful adherence to the defined limits.) |
| Image Quality: The modified measurement protocols, incorporating the new limitations, must maintain diagnostic image quality. | Image quality assessments of the modified measurement protocols: "The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared." (This implies that image quality was found acceptable for diagnostic purposes even with the new limitations.) Additionally, "clinical images were provided to support the imaging performance of the device when using the limitations of the new 'Implant Suite' feature." |
| Software Functionality and Safety: The new software features (Online Patient Safety supervision, safe reaction path, extended look-ahead functionality, internal supervision, Implant Suite UI, coil usage control, adapted pulse sequences) should function correctly and safely. | Software verification and validation testing: "completed in accordance with the FDA guidance document, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." The results demonstrated that "the device performs as intended." |
| Hardware Functionality and Safety: The modified hardware (segregated control path, supply-voltage supervisions, RF sensor data communication, segregated TX- switch-off path, new computer hardware) must function correctly and safely. | Non-clinical data suggests equivalent safety and performance: "While there are some differences in technological characteristics between the subject device and predicate device... these differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device." |
| Compliance with Standards: The device must conform to relevant medical device standards (e.g., IEC 62304, IEC 60601 series, ISO 14971, NEMA DICOM). | The document explicitly states compliance with: IEC 62304:2015, ES60601-1:2005/(R)2012 and A1:2012, 60601-1-2 Edition 4.0 2014-02, 60601-2-33 Ed. 3.2 B:2015, 14971 Second edition 2007-03-01, 60601-1-6 Edition 3.1 2013-10, 62366-1:2015, and NEMA PS 3.1 - 3.20 (2016). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for any of the performance tests (image quality assessments, FPO verification, or software V&V).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "clinical images were provided," suggesting real-world data, but details are lacking.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document states that "clinical images were provided to support the imaging performance of the device when using the limitations of the new 'Implant Suite' feature." It also mentions that images "when interpreted by a trained physician, yield information that may assist in diagnosis." However, it does not specify the number of experts, their qualifications (e.g., years of experience as a radiologist), or their role in establishing a formal ground truth for the test set used in the performance evaluation.
4. Adjudication Method for the Test Set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for interpreting the clinical images or evaluating the performance of the device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device." Therefore, no MRMC comparative effectiveness study involving human readers with and without AI assistance was performed or reported. The regulatory submission relies on non-clinical tests and demonstration of equivalent technical characteristics for safety and performance to the predicate device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This device is an MR scanner with updated software and hardware, not an AI algorithm that acts as a standalone diagnostic tool. The "Implant Suite" is a feature that modifies the scanner's operational parameters. Therefore, a standalone algorithm-only performance study (as would be typical for an AI-based diagnostic tool) is not applicable here and was not reported. The "software verification and validation testing" evaluates the correct functioning of the software features, including the new safety mechanisms, but not in the context of a standalone diagnostic algorithm.
7. Type of Ground Truth Used:
- For the non-clinical tests (FPO verification, software V&V), the "ground truth" would be the expected behavior based on engineering specifications and safety requirements.
- For the "clinical images," the implicit ground truth for evaluating "imaging performance" would likely be the diagnostic interpretation by a trained physician, but no formal process for establishing this ground truth is described. It is not pathology, outcomes data, or an expert consensus process in the way these are typically defined for diagnostic accuracy studies.
8. Sample Size for the Training Set:
- The document does not describe the development of a machine learning or AI model with a distinct "training set." The changes are primarily software modifications for safety features and operational limitations, along with associated hardware changes. Therefore, the concept of a "training set" in the context of machine learning is not directly applicable to this submission.
9. How the Ground Truth for the Training Set Was Established:
- As the device's modifications are not described as involving machine learning from a training set, the question of how ground truth for a training set was established is not relevant to this submission.
§ 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.