(185 days)
The MAGNETOM Skyra is indicated for use as a magnetic 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 Skyra 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.
TimTX TrueShape, an option for the MR system MAGNETOM Skyra, allows parallel transmission of RF pulses, shaping the RF excitation field locally and thus enabling selective excitation.
syngo ZOOMit (introduced with the software version syngo MR D13C) is the application that utilizes TimTX TrueShape. It allows "zooming into" a part of the human body by selective excitation.
The option TimTX TrueShape and syngo ZOOMit include two independent RF transmit paths fully integrated with the system, a modified whole-body RF coil, new options for B1 shimming, as well as new inline RF pulse generation. Pulse sequences allowing for different kinds of excitation, or zooming are derived from EPI and SPACE sequences. Protocol optimization for neurological, musculoskeletal, angiographic and oncological imaging is also inherent to the TimTX TrueShape option.
The provided document describes a 510(k) submission for a new Magnetic Resonance (MR) system option (TimTX TrueShape) and software version (syngo MR D13C) for the MAGNETOM Skyra. This is a submission for a device upgrade, not a new standalone AI/ML device, and thus does not contain the typical information about acceptance criteria and a study proving the device meets those criteria in the way one would expect for an AI/ML product.
Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (MAGNETOM Skyra with syngo MR D13A). This means the focus is on showing that the new features do not introduce new safety or effectiveness concerns, and that the device retains the core functionalities and performance of the predicate.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission. The "acceptance criteria" here relate more to regulatory compliance and demonstrating that the new features do not negatively impact the established safety and performance of the base device.
However, I can extract the relevant information that is provided and explain what is missing and why:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards. Product Risk Management in compliance with ISO 14971:2009. Minimize electrical and mechanical risks. No new issues of safety. | - Conformity to applicable FDA recognized and international IEC, ISO, and NEMA standards for performance and safety. |
- Product Risk Management accomplished through a process in compliance with ISO 14971:2009 to identify and mitigate potential hazards.
- Risks controlled via measures in software development, SW testing, and product labeling.
- Adherence to recognized industry practices and standards (e.g., IEC 60601-1 series) to minimize electrical and mechanical risk.
- Conclusion: "does not introduce any new issues of safety or effectiveness." |
| Effectiveness: Same intended use as predicate device. Same basic technical characteristics as predicate (magnetic resonance features and functionalities). Enhanced capabilities without introducing new effectiveness concerns. | - Intended Use: "The MAGNETOM Skyra is indicated for use as a magnetic 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... 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." (Unchanged from predicate) - Technical Characteristics: "has the same intended use and the same basic technical characteristics as the predecessor device MAGNETOM Skyra with syngo MR D13A, with respect to the magnetic resonance features and functionalities."
- Capability: "The differences... give the subject device greater capabilities than the predicate device, but have the enhanced technological characteristics as the predicate device."
- Conclusion: "does not introduce any new issues of safety or effectiveness." |
Explanation: In a 510(k) for an MR system update, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and proving that the new features (TimTX TrueShape and syngo MR D13C) do not alter the fundamental safety or effectiveness of the device beyond what was established for the predicate. The "reported device performance" is essentially the statement that these criteria have been met through the mentioned compliance and risk management processes.
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/Not Provided: This document describes a traditional 510(k) for a hardware and software upgrade to an MR system, not a clinical study on an AI/ML algorithm. Therefore, there is no "test set" in the sense of a dataset for evaluating an algorithm's performance on patient data. The evaluation primarily focuses on engineering verification and validation against technical specifications and safety standards.
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/Not Provided: See explanation for point 2. Ground truth in the context of an AI/ML algorithm's clinical performance is not relevant for this type of submission. The "ground truth" for an MR system's performance is typically established through phantom studies, engineering tests, and adherence to established imaging physics principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: See explanation for point 2 and 3.
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: No MRMC study was performed or described. This document is for a hardware and software upgrade to an MR scanner, not an AI/ML diagnostic aid that would assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: This is not an AI/ML algorithm that operates in a "standalone" fashion for diagnosis. It's a component of an imaging system. The performance of the imaging system as a whole is subject to regulatory requirements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: For an MR system upgrade, "ground truth" generally refers to physical measurements and known properties of phantoms, or established imaging capabilities. Clinical outcome data or pathology are not used to validate the core performance of the MR system itself in this context.
8. The sample size for the training set
- Not Applicable/Not Provided: This document does not describe the development or training of an AI/ML algorithm in the sense of a "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: See explanation for point 8.
§ 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.