(25 days)
The MAGNETOM 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.
The MAGNETOM system 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.
MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR include modified hardware compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A (K203443). A high-level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- The Nexaris Dockable Table is a variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR/ARTIS tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging.
The provided text is a 510(k) Summary for a medical device (MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies for novel claims.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not directly available in this document. The submission relies on demonstrating that the modified hardware of the new device maintains the safety and performance profile of the predicate device.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported device performance metrics for a novel diagnostic claim. Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful verification and validation of modified hardware, demonstrating equivalent safety and performance to the predicate device.
The reported "performance" is that the device "perform[s] as intended" and "bear[s] an equivalent safety and performance profile to that of the predicate device."
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Performance | Equivalent to predicate device | "Perform as intended" and "bear an equivalent safety and performance profile to that of the predicate device." |
| Standard Compliance | AAMI / ANSI ES60601-1 compliant | Verified |
| Standard Compliance | 21 CFR §820.30 compliant | Verified |
| Standard Compliance | IEC 62304 compliant | Conforms |
| Standard Compliance | ISO 14971 compliant | Risk management ensured |
| Standard Compliance | IEC 60601-1 series compliant | Adheres to minimize hazards |
| Standard Compliance | Other listed standards | Conforms |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable/not provided. The submission focuses on hardware modifications and compliance with standards, not on a clinical test set for diagnostic performance.
- Data Provenance: Not applicable/not provided for a clinical test set. The data provenance described is related to non-clinical performance testing of modified hardware against engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As there was no clinical diagnostic test set evaluated for novel claims, there was no need for experts to establish ground truth in this context. The "truth" evaluated was compliance with engineering and safety standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. No adjudications were performed related to a diagnostic test set.
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 MRMC comparative effectiveness study was done, as this submission is for a Magnetic Resonance Diagnostic Device (MRDD) and not an AI-assisted diagnostic tool or software. The document explicitly states: "No additional clinical tests were conducted to support substantial equivalence for the subject devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone performance study of an algorithm was done. This submission is for an MRDD system with modified hardware, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the nonclinical tests was based on engineering specifications, recognized safety standards (e.g., AAMI / ANSI ES60601-1, 21 CFR §820.30), and risk management principles (ISO 14971).
8. The Sample Size for the Training Set
Not applicable. This submission does not involve an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This submission does not involve an AI algorithm or a training set.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which in this context are interpreted as demonstrating safe and equivalent performance to the predicate device) was a series of nonclinical performance tests focused on the modified hardware.
- Study Type: Nonclinical performance testing (verification and validation against established standards and engineering requirements).
- Focus: Evaluation of "modified hardware" (Nexaris Dockable Table) to ensure it performs as intended and maintains the safety and performance profile of the predicate device.
- Tests Conducted:
- Electrical, mechanical, structural, and related system safety tests (utilizing AAMI / ANSI ES60601-1).
- Verification and validation (in accordance with 21 CFR §820.30).
- Conclusion: The results of these nonclinical tests demonstrated that the modified features "bear an equivalent safety and performance profile to that of the predicate device." The device also conforms to various recognized standards including IEC 62304, ISO 14971, IEC 60601-1 series, and others listed in the document.
In essence, the "study" was a comprehensive engineering and regulatory compliance assessment of the hardware changes, leveraging industry standards and internal verification processes instead of clinical performance studies with diagnostic endpoints.
§ 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.