(204 days)
The MAGNETOM Aera and the MAGNETOM Skyra systems are 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.
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 Aera and the MAGNETOM Skyra 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.
The software and some of the hardware of the previously cleared MAGNETOM Aera and MAGNETOM Skyra have been modified and updated. The updates enable new options, including sequences, applications, coils and coil adapters, for MAGNETOM Aera and MAGNETOM Skyra.
The provided document describes a 510(k) premarket notification for updates to the Siemens MAGNETOM Aera and MAGNETOM Skyra MRI systems. It does not contain a study proving the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics like accuracy, sensitivity, specificity, with a test set, ground truth established by experts, etc.).
This submission is for modifications and updates to existing MRI devices, encompassing new options, sequences, applications, coils, and coil adapters. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices and adherence to safety and effectiveness standards, rather than proving performance against specific quantitative acceptance criteria for a novel AI or diagnostic algorithm.
Therefore, many of the requested details about acceptance criteria, study design for performance validation, sample sizes, expert qualifications, and ground truth establishment are not present in this document.
Here's a breakdown of the information that can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a diagnostic task. The "acceptance criteria" here refer to regulatory compliance and demonstrating substantial equivalence to predicate devices, along with adherence to recognized standards (ISO 14971:2007, IEC 60601-1 series, FDA recognized and international IEC, ISO and NEMA standards).
- Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) are reported in this document. The "performance" discussed is related to the device's ability to produce images and spectra as a magnetic resonance diagnostic device, consistent with its intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/not provided. This submission is about hardware/software updates to an existing MRI system, not a study evaluating a diagnostic algorithm on a test set of patient data.
- Data Provenance: Not applicable/not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not provided. Ground truth establishment for a diagnostic algorithm is not described.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. There is no test set or diagnostic efficacy study described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This document does not present an MRMC study.
- Effect Size of Human Readers with AI vs Without AI: Not applicable, as no AI-assisted diagnostic claims or studies are presented.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No. This document does not describe a standalone performance study of an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable/not provided. No ground truth is established for diagnostic performance metrics in this document.
8. Sample Size for the Training Set
- Sample Size: Not applicable/not provided. This is not a submission for a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable/not provided.
Summary of what the document does describe regarding validation:
The validation approach for the modifications to the MAGNETOM Aera and MAGNETOM Skyra systems primarily relies on:
- Substantial Equivalence: Comparing the modified devices to a list of previously cleared predicate devices (K101347, K082427, K072237, K041112, K103275, K100113).
- Risk Management: Adherence to ISO 14971:2007 for identifying and mitigating potential hazards.
- Compliance with Standards: Conformance to applicable FDA recognized and international IEC, ISO, and NEMA standards (e.g., IEC 60601-1 series) for performance and safety.
- Device Labeling: Ensuring the device labeling contains appropriate instructions, cautions, and warnings for safe and effective use.
In essence, this 510(k) submission is for an incremental update to an established medical device, where the focus is on maintaining the established safety and effectiveness profile and demonstrating that the changes do not introduce new questions of safety or effectiveness compared to the predicate devices. It is not a submission for a novel diagnostic algorithm requiring extensive clinical performance studies with acceptance criteria based on 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.