(33 days)
The MAGNETOM Essenza 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Essenza may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biops y needles.
The MAGNETOM Essenza System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Siemens MAGNETOM Essenza:
Based on the provided 510(k) summary for the Siemens MAGNETOM Essenza (K071925), the device is a Magnetic Resonance Diagnostic Device (MRDD). The submission emphasizes substantial equivalence to previously cleared predicate devices (Siemens MAGNETOM 1.5 T Avanto, Software syngo MR VB15, and Siemens MAGNETOM 1.5 T Symphony).
Crucially, this submission does not describe a study to prove the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a test set against ground truth. Instead, the acceptance criteria are focused on conformance to established safety and performance standards for MRDDs to demonstrate substantial equivalence to predicate devices.
Let's break down the information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Statement |
|---|---|---|
| Safety and Effectiveness | Conformance to FDA recognized NEMA Standards for the measurement of performance and safety parameters. | "The MAGNETOM Essenza will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters..." |
| Safety and Effectiveness | Conformance to the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. | "...and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." |
| Substantial Equivalence | The device's hardware (modified gradient coil, RF body resonator, magnet) is of the same type as currently available in MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technology. | "It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy." |
| Overall Equivalence | Performance considered safe and effective similar to the currently available MAGNETOM Avanto and MAGNETOM Symphony 1.5 T systems. | "This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto and MAGNETOM Symphony 1.5 T systems." |
Note: The "reported device performance" here is a statement of intent and design comparability, rather than numerical performance metrics from a clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No specific test set or clinical study data is mentioned for the evaluation of diagnostic performance. The submission relies on technical comparisons and adherence to standards rather than a new clinical performance study.
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. No clinical test set requiring expert ground truth establishment is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is described.
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 device is a magnetic resonance diagnostic device (MRI scanner), not an AI-powered diagnostic tool. The submission is for the core imaging hardware and associated technology, not for an AI algorithm assistance to human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device (MRI scanner), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical diagnostic performance study requiring ground truth is described in this 510(k) summary. The "ground truth" for this submission are the established safety and performance standards for MRDDs and the characteristics of the predicate devices.
8. The sample size for the training set
- Not applicable. This submission does not describe an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or AI model is described.
Summary of Approach:
The 510(k) for the MAGNETOM Essenza focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving de novo clinical performance through efficacy studies. The "acceptance criteria" are therefore primarily regulatory and technical: conforming to recognized safety and performance standards (NEMA, IEC) and showcasing hardware and technological similarities to cleared devices. There is no mention of clinical studies involving patient data to establish diagnostic performance metrics like sensitivity or specificity.
§ 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.