(79 days)
The MAGNETOM Avanto is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Avanto 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 MAGNETOM Avanto 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 Sonata and Symphony systems.
Here's a breakdown of the acceptance criteria and the study information for the MAGNETOM Avanto System, based on the provided text.
Based on the provided 510(k) summary, the MAGNETOM Avanto System is a 1.5 T closed superconducting magnet designed scanner which is substantially equivalent to previously cleared magnetic resonance diagnostic devices (MRDDs). The evaluation primarily focuses on safety and performance parameters compared to these predicate devices, rather than a clinical study demonstrating diagnostic accuracy in a specific patient population.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MAGNETOM Avanto System are based on its substantial equivalence to the predicate devices (Siemens MAGNETOM 1.5 T Sonata and Siemens MAGNETOM 1.5 T Symphony) and adherence to recognized standards. The "reported device performance" in this context refers to the device's conformance to these established safety and performance levels, ensuring it is at least as safe and effective as the predicates.
| Category | Acceptance Criteria (Reference Standard/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Safety Parameters | Substantially equivalent to commercially available MAGNETOM 1.5 T Sonata System and 1.5 T Symphony System, adhering to FDA guidance document for MR Diagnostic Devices. This includes specific action levels for: |
- Maximum Static Field
- Rate of Change of Magnetic Field
- RF Power Deposition
- Acoustic Noise Levels | The MAGNETOM Avanto will conform to the FDA recognized NEMA Standards for the measurement of safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. (Implies satisfactory performance meeting these standards, leading to substantial equivalence). |
| Performance Parameters | Substantially equivalent to commercially available MAGNETOM 1.5 T Sonata System and 1.5 T Symphony System, adhering to FDA guidance document for MR Diagnostic Devices. This includes specific performance levels for: - Specification Volume
- Signal to Noise
- Image Uniformity
- Geometric Distortion
- Slice Profile, Thickness and Gap
- High Contrast Spatial Resolution | The MAGNETOM Avanto will conform to the FDA recognized NEMA Standards for the measurement of performance parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. (Implies satisfactory performance meeting these standards, leading to substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not describe a clinical test set in the traditional sense of a study involving patient data for diagnostic accuracy. The evaluation revolves around engineering and physical measurements to demonstrate conformance to standards and equivalence to predicate devices. There is no mention of a specific "test set" of patient images or data used for a clinical performance evaluation. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, there was no clinical test set requiring ground truth established by experts for diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on technical and safety equivalence to predicate devices, not on a direct comparison of human reader performance with and without AI assistance for this specific device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a Magnetic Resonance Diagnostic Device (MRDD), an imaging system. It's not an AI algorithm that exists independently of human interpretation. Its performance is inherent in the quality of the images and spectra it produces, which are then interpreted by a trained physician. Therefore, the concept of a "standalone" AI algorithm performance is not applicable to this type of device submission.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established technical and safety standards, as well as the performance characteristics of the predicate devices. The study implicitly uses these established standards and predicate device performance as the "ground truth" against which the new device's conformance is measured. There is no mention of pathology, outcomes data, or expert consensus on clinical diagnoses as ground truth for a diagnostic performance study.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware imaging system, not an AI algorithm that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.
§ 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.