(67 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/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 MR system may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.
The subject device, MAGNETOM Avanto® with software syngo MR E11E. is a modification of the previously cleared predicate device, MAGNETOM Avanto" with software syngo MR E11C-AP04 (K173592). The software version syngo E11E for MAGNETOM Avanto™ has been modified to include the software application "Compressed Sensing (CS) Cardiac Cine." This software application was migrated unchanged from the previously cleared MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312).
The provided document is a 510(k) summary for the Siemens MAGNETOM Avanto® with software syngo MR E11E. It details the device's substantial equivalence to a predicate device, focusing on a new software feature. However, this document does not contain the specific information required to answer your detailed questions about acceptance criteria and a study proving the device meets those criteria.
The 510(k) summary states:
- No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device (page 7).
- Nonclinical performance testing was conducted, including software verification and validation, and performance testing in accordance with FDA guidance documents (page 6). However, it does not provide details of acceptance criteria for these tests or specific results in numerical form that can be presented in a table against a predefined "acceptance criteria."
- The document implies that the "new" feature (Compressed Sensing (CS) Cardiac Cine) was migrated unchanged from a previously cleared device (MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312)). This suggests that the performance and safety of this feature were established in the clearance of the reference device, not necessarily re-tested as a new standalone study for this specific 510(k).
Therefore, based solely on the provided text, I cannot extract the following information:
- A table of acceptance criteria and the reported device performance: This document reports that testing was done and standards were conformed to, but not the specific metrics, thresholds, or measured values.
- Sample size used for the test set and the data provenance: Clinical test data with sample sizes are not present, and for nonclinical tests, specific "test sets" in the sense of patient data are not detailed.
- Number of experts used to establish the ground truth and their qualifications: As no clinical study is reported, this information is not applicable to the data provided.
- Adjudication method for the test set: Not applicable without a clinical study.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: The document explicitly states "No clinical tests were conducted."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While "performance testing" was mentioned for nonclinical data, the specifics of an algorithm-only standalone study with human-level metrics are not provided.
- The type of ground truth used: Not specified, as clinical data and ground truth establishment methods are not detailed.
- The sample size for the training set: This is a 510(k) for a hardware/software system, not an AI/ML device that typically has a "training set" in the context of deep learning. The new feature is a "Compressed Sensing (CS) Cardiac Cine" software application, which is a signal processing technique, not necessarily a machine learning algorithm that requires a "training set" in the conventional AI sense.
- How the ground truth for the training set was established: Not applicable for the reasons mentioned above.
Conclusion based on the provided document:
The 510(k) summary focuses on demonstrating substantial equivalence through:
- Confirmation that the device's indications for use are the same as the predicate device.
- Confirmation that the new software feature ("Compressed Sensing (CS) Cardiac Cine") was migrated unchanged from an already cleared reference device (K163312).
- Compliance with recognized standards (IEC, ISO, NEMA) for safety and software development.
- Software verification and validation testing, and general device performance testing, all non-clinical.
The document does not contain the details of a study with specific acceptance criteria, reported performance metrics, or clinical ground truth establishment as requested in your prompt. This type of detailed performance data is typically found in accompanying test protocols and reports, which are part of the larger 510(k) submission but not always fully summarized in the publicly available 510(k) summary.
§ 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.