(48 days)
The MAGNETOM MR system [Acra/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 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 MR system | Acra/Skyra] may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.
MAGNETOM Artis Combi Suite is the marketing name for the modification of MAGNETOM Aera and MAGNETOM Skyra to include a modified dockable table for use with a standalone Artis system in a clinical workflow. The market name, MAGNETOM Artis Combi Suite, refers to a sales bundle of single items that have been combined to build up a patient transfer workflow from one medical device to another.
MAGNETOM Artis Combi Suite enables the user to move a patient via a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner.
The intended use of the MAGNETOM Aera and MAGNETOM Skyra as well as Artis imaging systems remains unchanged.
The MAGNETOM Artis Combi Suite will only be available for MAGNETOM systems Aera and Skyra and will be available as an option to new manufactured scanners; existing scanners can be upgraded to this sales bundle. The sales bundles include new hardware for the MAGNETOM systems Aera and Skyra.
The provided text describes a 510(k) submission for the "MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra." This device is a sales bundle that enables the transfer of a patient on a patient transfer board from an angiography system to an MR scanner.
The submission focuses on establishing substantial equivalence to legally marketed predicate devices, not on proving a specific clinical performance metric with acceptance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study to prove the device meets acceptance criteria" as typically applied to diagnostic algorithms or devices with measurable performance metrics (sensitivity, specificity, accuracy) does not directly apply here.
The "acceptance criteria" in this context are the requirements for demonstrating substantial equivalence to a predicate device, as outlined by the FDA. The "study" is the information provided in the 510(k) summary to support this claim of substantial equivalence.
Here's how to interpret the request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance/Information in 510(k) |
|---|---|
| Intended Use: Device has the same intended use as legally marketed predicate devices. | "The intended use of the MAGNETOM Aera and MAGNETOM Skyra as well as Artis imaging systems remains unchanged." "MAGNETOM Aera and MAGNETOM Skyra and software syngo MR D13A with MAGNETOM Artis Combi Suite as well as MAGNETOM Skyra and software syngo MR D13C with MAGNETOM Artis Combi Suite has the same intended use... as the predicate devices with respect to the magnetic resonance features and functionalities." |
| Technological Characteristics: Device has substantially equivalent technological characteristics to predicate devices. | "The functionality of MAGNETOM Artis Combi Suite remains similar to that of the predicate devices, MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A and syngo MR D13C for MAGNETOM Skyra." The document also lists specific predicates and mentions that the Artis Combi Suite includes "new hardware for the MAGNETOM systems Aera and Skyra." The primary difference is the "additional capabilities by allowing the user to move a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner." |
| Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety and effectiveness. | "There are no new issues of safety or effectiveness introduced with the MAGNETOM Artis Combi Suite." "Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007." "Adhere to recognized and established industry standards, such as the IEC 60601-1 series." "Conform to the applicable FDA recognized and international IEC, ISO and NEMA standards." |
| Performance Data: Sufficient data to support the claims of substantial equivalence (e.g., non-clinical testing, compliance with standards). | The document implicitly relies on the existing clearances of the predicate devices and general compliance with industry standards. No specific new performance data (e.g., patient transfer speed, structural integrity testing) is detailed in this summary, but it states that "Risk Management is ensured" and the devices "conform to the applicable FDA recognized and international IEC, ISO and NEMA standards." |
2. Sample Size for the Test Set and Data Provenance
Not applicable in the traditional sense for this type of 510(k) submission. This is not a study assessing diagnostic performance on a patient dataset. The "test set" here refers to the technical evaluation and comparison to predicate devices, not a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as in "expert consensus" for clinical findings is not relevant to this submission, which focuses on device modification and substantial equivalence. The "experts" involved would be the engineers and regulatory affairs specialists who conducted the risk analysis and ensured compliance with standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of clinical adjudication. The assessment is regulatory and technical against standards and predicate devices.
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
Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not a standalone algorithm. It's a hardware modification and workflow integration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is established through compliance with regulatory standards (e.g., ISO 14971:2007 for risk management, IEC 60601-1 series for electrical and mechanical hazards) and demonstrated substantial equivalence to predicate devices, rather than clinical outcomes or pathology.
8. The sample size for the training set
Not applicable. This is not machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. This is not machine learning or AI.
§ 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.