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Your MAGNETOM system 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.

Your MAGNETOM system 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.

Software syngo MR E11E with Ischemic Heart Disease (HD) Workflow, when used with a gadolinium-based contrast agent (GBCA) approved for cardiac MRI (CMRI) is indicated for the acquisition and display of images of myocardial perfusion (stress, rest) and late gadolinium enhancement (LGE) during post-contrast CMRI examination in patients with known or suspected coronary artery disease (CAD).

MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with IHD Workflow are the subject devices. The Software syngo MR E11E with IHD Workflow, when used with a gadolinium-based contrast agent (GBCA) approved for CMRI, extends the capability of the cleared Cardiac Dot Engine (K121434) for post-contrast CMRI exams for patients with known or suspected coronary artery disease (CAD). Software syngo MR E11E with IHD Workflow is available for MAGNETOM Aera and MAGNETOM Skyra excluding the 24-channel configuration.

A. The cleared Cardiac Dot Engine (syngo MR D13A, K121434) helps acquisition and display of cardiac morphology and function (noncontrast CMRI).
A comprehensive post-contrast CMRI exam includes stress/rest perfusion and late gadolinium enhanced (LGE) imaging. To accomplish post-contrast CMRI imaging, basic morphologic / functional imaging (noncontrast CMRI) is required. Therefore, the cleared Cardiac Dot Engine (syngo MR D13A, K121434) is a pre-requisite to the subject devices.

B. The Cardiac Dot Engine together with the IHD Workflow and a GBCA approved for post-contrast CMRI provides for a complete (pre- and post-contrast) examination.

The primary predicate devices are modified to include a new Dot Workflow named "Ischemic Heart Disease" (IHD) Workflow for a post-contrast CMRI exam using pulse sequences already cleared in the USA (syngo MR D13A, K121434). A new Dot Workflow "Ischemic Heart Disease" is added in Cardiac Dot Engine dropdown list, under the region "heart". This Dot Workflow includes the following: six new post-contrast CMRI measurement protocols and one workflow step:

New Measurement protocols:

1. DynamicTest (test protocol for perfusion imaging without contrast agent)
2. DynamicStress (protocol for perfusion imaging under stress conditions)
3. DynamicRest (protocol for perfusion imaging under rest conditions)
4. DE overview (protocol for delayed enhancement (DE) or LGE with low spatial resolution as an overview)
5. DE_seg_high-res_LAX (protocol for DE or LGE with high spatial resolution in long axis view)
6. DE seg high-res SAX (protocol for DE or LGE with high spatial resolution in short axis view)

New workflow step:

1. Inject contrast agent. This step prompts the user to start the contrast agent injection for post-contrast CMRI exams.

This document describes the regulatory approval for the Siemens MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow. The IHD Workflow is an extension to the cleared Cardiac Dot Engine, intended for post-contrast Cardiac MRI (CMRI) exams for patients with known or suspected Coronary Artery Disease (CAD).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or quantitative performance metrics for the IHD Workflow. Instead, it refers to the efficacy results of two clinical studies (GadaCAD1 and GadaCAD2) to support the device's performance. The "acceptance criteria" can therefore be inferred as the successful demonstration of the device's ability to acquire and display myocardial perfusion and late gadolinium enhancement (LGE) images that adequately detect CAD when interpreted by qualified readers.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: A total of 764 subjects were evaluated across two studies: 376 subjects in GadaCAD1 and 388 subjects in GadaCAD2. These subjects represent the test set for evaluating the post-gadobutrol CMRI capabilities.
• Data Provenance: The GadaCAD studies were prospectively controlled, multi-national, single-arm clinical studies. The document states that they were performed by Bayer HealthCare AG.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: The document states that the CMRI images were "interpreted by qualified independent readers". While it doesn't specify an exact number, the use of "readers" (plural) across multi-center, multi-national studies implies multiple experts were involved in the interpretation process.
• Qualifications of Experts: The readers were described as "radiologists and cardiologists experienced in CMRI".

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth from the expert interpretations in the GadaCAD studies. It simply states that the images were "interpreted by qualified independent readers." The primary endpoint of the GadaCAD studies, as mentioned in the GADAVIST™ package insert, was likely the diagnostic accuracy of CMRI for CAD detection, which would have implicitly relied on these interpretations, but the specific consensus mechanism is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study designed to assess the improvement of human readers with AI vs. without AI assistance.
• The IHD Workflow is presented as a set of modified measurement protocols and a workflow step for image acquisition and display, extending the capabilities of the existing Cardiac Dot Engine. The clinical studies evaluated the efficacy of the imaging technique itself (using the IHD Workflow components) for CAD detection, not the comparative performance of human readers with and without AI assistance for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The document does not present a standalone performance study for an algorithm without human-in-the-loop performance.
• The IHD Workflow focuses on image acquisition and display protocols. The interpretation of these images for diagnosis still relies on "trained physicians." The clinical studies validate the acquisition and display capabilities to produce images sufficient for expert interpretation.

7. Type of Ground Truth Used

The ground truth used in the GadaCAD studies was expert consensus / clinical interpretation by qualified independent readers (radiologists and cardiologists experienced in CMRI) for the detection of CAD. The document explicitly states: "The post-gadobutrol CMRI specific acquisition protocols supported adequate detection of CAD in two multi-center, multinational clinical studies."

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. The IHD Workflow's development and validation are largely described in terms of non-clinical software verification and validation, and clinical validation using the GadaCAD studies. The GadaCAD studies served as the validation set for the device's performance, not a training set for an AI/algorithm component requiring labeled data for learning. The IHD Workflow primarily introduces new measurement protocols and a workflow step, not necessarily a machine learning algorithm that requires a distinct training set in the conventional sense.

9. How Ground Truth for the Training Set Was Established

Since no training set is explicitly mentioned or relevant for the described IHD Workflow (which consists of acquisition protocols and workflow steps, not an AI model requiring a training phase), the method for establishing ground truth for a training set is not applicable/not provided in this document.

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Your MAGNETOM MR 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 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 inages 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.

Your MAGNETOM MR 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 Aera and MAGNETOM Skyra with syngo MR E11C Software is cleared with K153343. To address the Compressed Sensing Cardiac Cine and the modified Software Features described in this Premarket Notification Siemens intends to make the Software Application Package syngo MR E11C - AP02 available to the MAGNETOM Aera and Skyra.

The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:

• . MAGNETOM Aera,
• MAGNETOM Skyra .

The additional Options for the MR Scanner Software syngo MR E11C include a new feature with a new sequence and modified features for the above mentioned MR systems. A high level summary of sequences, features and improvements made available for the above systems is included below.

The provided text describes a 510(k) premarket notification for Siemens Medical Solutions USA, Inc.'s MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software. This document is a summary of the safety and effectiveness information supporting substantial equivalence to a predicate device.

However, the document specifically states: "No clinical tests were conducted to support the subject devices and the substantial equivalence argument; however, clinical images and LV evaluation were provided to support the argumentation and documentation which demonstrate the clinical utility and technical capabilities of the method."

This means that the information requested regarding acceptance criteria and a study proving the device meets these criteria (including details on sample size, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details) is not available in this document because a clinical study of this nature was not performed.

The substantial equivalence argument is based on non-clinical tests (image quality assessments, software verification and validation, and demonstrating similar technological characteristics to the predicate device) rather than a comparative clinical study.

Therefore, I cannot provide a detailed answer to your request based on the provided text, as the specific clinical study details you're asking for were explicitly stated as not having been conducted.

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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.

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