(49 days)
The MAGNETOM Avanto" and the MAGNETOM Skyra" systems are indicated for use as a maqnetic resonance diagnostic 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.
The MAGNETOM Avanto® and the MAGNETOM Skyra® MR systems 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.
MAGNETOM Avanto® (1.5 T) and MAGNETOM Skyra® (3 T) are similar to the previously cleared MAGNETOM Aera (1.5 T) and MAGNETOM Skyra (3 T) systems utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.
The MAGNETOM Avanto® and the MAGNETOM Skyra® systems will be offered as an upgrade to the currently installed MAGNETOM Avanto and MAGENTOM Verio systems. The MAGNETOM Avanto® will also be offered as ex-factory (new production).
The provided text describes a 510(k) premarket notification for Siemens' MAGNETOM Avanto-Fit and MAGNETOM Skyra-Fit MR systems. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria, as one would expect for an AI/ML powered device.
The devices in question are magnetic resonance diagnostic devices (MRDDs), which are hardware systems, not AI models. Therefore, the typical "acceptance criteria" and "study" an AI/ML device would undergo (e.g., performance metrics like sensitivity, specificity, AUC, human reader improvement) are not applicable here.
However, based on the information provided, I can extract the safety and performance measurements that serve as the "acceptance criteria" for these MRI systems and how their equivalence was asserted rather than "proven through a study" in the AI/ML sense.
1. Table of Acceptance Criteria and Reported Device Performance
For an MRI device, acceptance criteria are generally related to safety and imaging performance standards. These are listed as "General Safety and Effectiveness Concerns" and "measurements of performance and safety data."
| Acceptance Criteria Category | Specific Criteria (NEMA/IEC/ISO Standards) | Reported Device Performance |
|---|---|---|
| Safety | Maximum Static Field | Asserted Equivalence: Performance measurements were done on the predicate devices (MAGNETOM Avanto and MAGNETOM Verio) to show that the performance of the MAGNETOM Avanto® and MAGNETOM Skyra™ with syngo® MR VD 13B Software is equivalent with respect to the predicate devices. This implies the new devices meet or are equivalent to the safety and performance metrics of the cleared predicate devices. |
| Rate of Change of Magnetic Field | ||
| RF Power Deposition | ||
| Acoustic Noise Levels | ||
| Performance | Specification Volume | Asserted Equivalence: The document states, "This will assure that the performance of these devices can be considered as safe and effective with respect to the currently available MAGNETOM Aera and MAGNETOM Skyra MR systems." |
| Signal to Noise | ||
| Image Uniformity | ||
| Geometric Distortion | ||
| Slice Profile, Thickness and Gap | ||
| High Contrast Spatial Resolution |
Explanation of "Reported Device Performance": The document does not provide specific numerical outcomes for each of these criteria for the new devices. Instead, it asserts that "Operation of the MAGNETOM Avanto™ (1.5T) and the MAGNETOM Skyra™ (3T) systems with syngo® MR VD13B software is substantially equivalent to the commercially available MAGNETOM Aera (1.5T) and MAGNETOM Skyra (3T) Systems with syngo® MR VD13A SW (K121434)." And, "performance measurements have been done on the predicate devices MAGNETOM Avanto and MAGNETOM Verio to show that the performance of the MAGNETOM Avanto® and MAGNETOM Skyra™ with syngo® MR VD 13B Software is equivalent with respect to the predicate devices." This implies that the new devices were tested against the same standards that the predicate devices met, demonstrating equivalence.
The subsequent questions (2-9) are highly specific to AI/ML device studies involving ground truth establishment, expert review, and sample sizes for training/test sets. Since the provided text describes a submission for an MRI hardware system and not an AI/ML algorithm, these questions are largely not applicable or cannot be answered from the provided text.
Here's why and what can be inferred:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for a hardware device in this context. The "test set" for an MRI hardware system typically involves phantom measurements and potentially human volunteer studies for safety and performance, not a dataset of medical images for AI performance evaluation. The document mentions "performance measurements have been done on the predicate devices" to show equivalence, but specific "sample sizes" (e.g., number of patients/scans in an image dataset) are not provided as it's not an AI evaluation.
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)
- Not applicable. Ground truth in the AI/ML sense (e.g., disease presence/absence for image interpretation) is not established for the device's performance itself in this submission. The device produces images, which are then interpreted by a trained physician (as stated in the "Intended Use"). This refers to the end-user clinical interpretation, not ground truth for algorithm training/testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a test set is described as this is a hardware device submission, not an AI algorithm study.
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. This document explicitly concerns the MRI hardware system itself, not an AI-assisted diagnostic tool. Therefore, no MRMC study or effect size related to AI assistance is presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device. The concept of an "algorithm only" performance study is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For an MRI hardware system, "ground truth" relates to physical measurements (e.g., geometric accuracy measured against known phantoms, signal-to-noise ratios in controlled environments), not clinical pathology or outcomes data in the context of an AI algorithm's diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This submission is for MRI hardware. There is no AI model "training set" described in the context of this document.
9. How the ground truth for the training set was established
- Not applicable. No AI model training set is mentioned.
§ 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.