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The MAGNETOM ESSENZA with syngo MR E11Q is indicated for use as magnetic resonance diagnostic devices (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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

The MAGNETOM ESSENZA 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 subject device, MAGNETOM ESSENZA with software syngo MR E11Q, is the latest software version for the Siemens MR MAGNETOM ESSENZA. It is modified based on the software version syngo MR E11A, which was cleared with K141977 on November 19, 2014. The software functionality and applications are based on syngo MR E11A SW and have been migrated from this previously cleared software. Only minor adaptations were needed to support the system specific hardware and to optimize the sequence/protocols, also to support the DGSU (Digital Gradient Small signal Unit) option for GPA (Gradient Power Amplifier).

Listed below are the hardware updates to the MAGNETOM ESSENZA system with software syngo MR E11Q:

• a modified MARS(Measurement and Reconstruction System), which is the same . as the MaRS of MAGNETOM Amira system with software syngo MR E11N (K152283, cleared on December 24, 2015)
• . an updated MRAWP (MR Syngo Acquisition Workplace), which is the same as the host platform of reference device MAGNETOM Amira with syngo MR E11N (K152283, cleared on December 24, 2015)
• . a successor EOSC (Electrical Optical Signal Converter) of original COB (CAN Open Bridge)

The MAGNETOM ESSENZA with software version syngo MR E11Q will be offered exfactory (new production) as well as in-field upgrades for the currently installed MAGNETOM ESSENZA systems.

A summary of the software feature updates to the MAGNETOM ESSENZA system with software synqo MR E11Q is provided below. All migrated features listed below have been cleared previously with K141977, K151579, and K152283.

The provided document describes the Siemens MAGNETOM ESSENZA with syngo MR E11Q, a magnetic resonance diagnostic device. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device with performance metrics against a defined acceptance criterion.

Therefore, the document does not contain information related to acceptance criteria, device performance, sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets.

Instead, the submission details:

• Device Name: MAGNETOM ESSENZA with syngo MR E11Q
• Intended Use/Indications for Use: To produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra 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, assist in diagnosis. It may also be used for imaging during interventional procedures with MR compatible devices.
• Device Description: The latest software version for the Siemens MR MAGNETOM ESSENZA, modified from syngo MR E11A (cleared with K141977). Adaptations support system-specific hardware, optimize sequence/protocols, and support the DGSU (Digital Gradient Small signal Unit) option for GPA (Gradient Power Amplifier).
• Hardware Updates: Modified MARS (Measurement and Reconstruction System), updated MRAWP (MR Syngo Acquisition Workplace), and a successor EOSC (Electrical Optical Signal Converter).
• Migrated Software Features (previously cleared with K141977, K151579, and K152283): MyoMaps, Quiet Suite, 10-min Exam Dot Engine, Spine Dot Engine, Breast Dot Engine, Large Joint Dot Engine, Neuro fMRI Package, DTI Package, Neuro Perfusion Package, FREEZEit Body MRI Package, LiverLab, BOLD 3D Evaluation, DTI Evaluation.
• Technological Characteristics: Substantially equivalent to predicate MAGNETOM ESSENZA with syngo MR D14 regarding MR image acquisition steps/features, operational environment, programming language, operating system, and performance. Both conform to IEC 62304:2006, IEC, and NEMA standards.
• Nonclinical Tests:
  • Description: All software features were verified and validated to perform as intended. Updated hardware (MaRS, MRAWP, EOSC) was tested in system and integration tests. All functionality and performance were tested in system and integration tests.
  • Results: Tests demonstrated the device performs as intended and is substantially equivalent to predicate devices.
• Clinical Tests: None were conducted.
• Safety and Effectiveness: Labeling contains instructions, cautions, and warnings. Risk management is ensured via ISO 14971:2007 risk analysis. Adheres to IEC 60601-1 series to minimize electrical and mechanical risk. Conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards.
• Predicate Devices:
  • Primary: MAGNETOM ESSENZA with syngo MR D14 (K130262, cleared March 1, 2013)
  • Secondary: MAGNETOM Aera with syngo MR E11A (K141977, cleared November 19, 2014)
• Reference Devices:
  • MAGNETOM Amira with syngo MR E11N (K152283, cleared December 24, 2015)
  • MAGNETOM Aera with syngo MR E11B (K151579, cleared September 29, 2015)
• Conclusion: The device is substantially equivalent as there are no changes to the Indications for Use compared to the primary predicate, and the new software features/capabilities are already cleared with the secondary predicate. The different technological characteristics do not raise new questions of safety and effectiveness as all features have been tested and verified/validated.

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The MAGNETOM ESSENZA with syngo MR D14 is indicated for use as magnetic resonance diagnostic devices (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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM ESSENZA 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 ESSENZA is being upgraded with software syngo MR D14. The MAGNETOM ESSENZA is a 1.5T, whole body scanner designed for economical optimized reasons. Siemens intends to modify the cover, gradient coil, Physiological Measurement Unit (PMU), Measurement and Reconstruction System (MaRS), update the software and add two new coils for the existing MAGNETOM ESSENZA Magnetic Resonance System.

The provided document is a 510(k) summary for the Siemens MAGNETOM ESSENZA 1.5T System with syngo MR D14 software. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to regulatory standards for a Magnetic Resonance Diagnostic Device (MRDD).

Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the diagnostic accuracy (e.g., sensitivity, specificity) of an AI-powered diagnostic algorithm.

The 510(k) submission for the MAGNETOM ESSENZA with syngo MR D14 is for an imaging hardware system (a 1.5T MRI scanner) with updated software, coils, and mechanical components. It is not for an AI/algorithm-driven diagnostic aid. Therefore, the types of studies and acceptance criteria typically associated with AI-powered diagnostic devices (e.g., MRMC studies, sensitivity/specificity targets, expert adjudication for ground truth) are not applicable to this specific submission and are consequently not present in the provided text.

The document indicates that the device's substantial equivalence is based on:

• Its intended use being the same as the predicate (K071925).
• The fact that it is an upgrade to an existing, cleared MRI system.
• Conformity to applicable FDA-recognized and international IEC, ISO, and NEMA standards for performance and safety.
• Risk management in compliance with ISO 14971:2007.

Therefore, I cannot populate the requested table or answer the specific questions related to AI acceptance criteria and performance studies based on the provided text.

To reiterate, the provided document describes a magnetic resonance diagnostic device (MRI scanner), not an AI-driven diagnostic algorithm. The "performance" discussed in this context relates to the safety and functionality of the imaging system itself, not the diagnostic accuracy of an AI interpreting images.

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The MAGNETOM Essenza 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Essenza may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biops y needles.

The MAGNETOM Essenza 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 Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Siemens MAGNETOM Essenza:

Based on the provided 510(k) summary for the Siemens MAGNETOM Essenza (K071925), the device is a Magnetic Resonance Diagnostic Device (MRDD). The submission emphasizes substantial equivalence to previously cleared predicate devices (Siemens MAGNETOM 1.5 T Avanto, Software syngo MR VB15, and Siemens MAGNETOM 1.5 T Symphony).

Crucially, this submission does not describe a study to prove the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a test set against ground truth. Instead, the acceptance criteria are focused on conformance to established safety and performance standards for MRDDs to demonstrate substantial equivalence to predicate devices.

Let's break down the information based on your requested categories:

1. A table of acceptance criteria and the reported device performance

Note: The "reported device performance" here is a statement of intent and design comparability, rather than numerical performance metrics from a clinical study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• No specific test set or clinical study data is mentioned for the evaluation of diagnostic performance. The submission relies on technical comparisons and adherence to standards rather than a new clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set requiring expert ground truth establishment is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set requiring adjudication is described.

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. This device is a magnetic resonance diagnostic device (MRI scanner), not an AI-powered diagnostic tool. The submission is for the core imaging hardware and associated technology, not for an AI algorithm assistance to human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a hardware device (MRI scanner), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No clinical diagnostic performance study requiring ground truth is described in this 510(k) summary. The "ground truth" for this submission are the established safety and performance standards for MRDDs and the characteristics of the predicate devices.

8. The sample size for the training set

• Not applicable. This submission does not describe an AI/machine learning model that would require a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set or AI model is described.

Summary of Approach:

The 510(k) for the MAGNETOM Essenza focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving de novo clinical performance through efficacy studies. The "acceptance criteria" are therefore primarily regulatory and technical: conforming to recognized safety and performance standards (NEMA, IEC) and showcasing hardware and technological similarities to cleared devices. There is no mention of clinical studies involving patient data to establish diagnostic performance metrics like sensitivity or specificity.

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