Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist.

Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist. The images produced by the MAGNETOM ESSENZA with the, 14-Channel Extremity Coil reflects the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.

The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.

Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist.

The provided text describes the 510(k) summary for the Siemens 14-Channel Extremity Coil for 1.5T MAGNETOM ESSENZA. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria, particularly for performance metrics that would typically involve a test set, expert adjudication, or MRMC studies.

Here's an breakdown of what can be extracted and what is missing:

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

The document lists safety and performance parameters considered, but it does not specify quantitative acceptance criteria or specific reported device performance values against these criteria. Instead, it states that these parameters were considered and that testing showed equivalence with a predicate device.

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

This information is not provided in the document. The document refers to "laboratory testing" but does not detail the nature of the test set (e.g., patient data, phantom studies), sample size, or provenance. This is a device modification for an existing technology (MR coil), and typically for such submissions, the focus is on technical equivalence rather than clinical performance studies with patient data.

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)

This information is not provided. Given the nature of a magnetic resonance coil submission, it's unlikely that expert-adjudicated ground truth for a test set of clinical images would be a primary requirement unless novel image interpretation features were introduced. The document emphasizes technical equivalence.

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

This information is not provided.

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

An MRMC comparative effectiveness study was not conducted or mentioned. This is not an AI-assisted device; it's a hardware component (an MRI coil). Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This is not an AI algorithm. It is a hardware component. Therefore, a standalone algorithm performance study is not applicable.

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

The document primarily relies on technical performance metrics (e.g., SNR, uniformity, SAR) and comparison to a predicate device. If patient images were used in testing, the ground truth source is not specified, and typically for coil submissions, the "ground truth" would be the objective measurements of image quality and safety parameters.

8. The sample size for the training set

This is not an AI/software device that requires a training set. This information is not applicable and not provided.

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

This is not an AI/software device that requires a training set. This information is not applicable and not provided.

Summary of the Study (as described in the document):

The study primarily focused on demonstrating substantial equivalence to a predicate device (QED TxRx 15Ch Knee Coil 1.5T). The method involved:

• Comparison of Intended Use and Device Description: Showing the new coil is used for the same anatomical regions and produces the same types of images as the predicate.
• Assessment of Safety Parameters: Verifying that parameters like Maximum Static Field, Rate of Change of Magnetic Field, and Acoustic Noise Level are unaffected, and that RF Power Deposition (SAR) and Biocompatibility are equivalent to the predicate device.
• Assessment of Performance Parameters: Verifying that Geometric Distortion, Slice Profile, Thickness and Gap, and High Contrast Spatial Resolution are unaffected, and that Signal to Noise Ratio (SNR) and Image Uniformity are equivalent to the predicate device.
• Laboratory Testing: "Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness." This testing specifically covered SNR, image uniformity, and SAR.

The document states that the results presented in the submission show that they (SNR, image uniformity, SAR) are equivalent with the predicate devices. This "equivalence" is the primary acceptance criterion and the outcome of the study.

Ask a specific question about this device

The speciality coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the body. These images when interpreted by a trained physician yield information that may assist in diagnosis.

The Speciality Coils are intended to be used in conjunction with the MAGNETOM ESSENZA, a Magnetic Resonance Diagnostic Device. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced. The Speciality Coils will include: 8-Channel Wrist Coil, 4-Channel Special-Purpose Coil, 8-Channel Foot-Ankle Coil, and the Focus Shoulder Array Coil, Small for the existing 1.5T MAGNETOM ESSENZA Magnetic Resonance System.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the modification of existing coils and the introduction of new specialty coils for an MRI system. The key acceptance criteria revolve around safety and performance parameters, particularly Signal-to-Noise Ratio (SNR) and Image Uniformity, compared to predicate devices.

Study Details

The provided document describes a bench testing approach to demonstrate substantial equivalence, rather than a clinical study involving human subjects or artificial intelligence performance evaluation.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the specialty coils themselves, which were tested in a laboratory setting. No patient data or images are referenced as a "test set" in the context of an AI/human performance study. The testing was conducted in a laboratory, so the data provenance would be "in-house laboratory testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for image quality metrics like SNR and uniformity is established through physical measurements and phantom studies, not typically through human expert consensus, especially for hardware (coils) evaluation.

3. Adjudication method for the test set: Not applicable. The assessment was based on objective physical measurements of the coils' performance.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This submission is for MRI hardware (specialty coils), not an AI algorithm or diagnostic software that would typically undergo such a study. The focus is on the physical performance and safety of the coils themselves.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This submission is for hardware.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance parameters (SNR, Image Uniformity) would be based on objective physical measurements using phantoms and established MR safety and performance measurement protocols. This is a technical validation of hardware, not a diagnostic accuracy study.

7. The sample size for the training set: Not applicable. The device is a set of MRI coils, not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this hardware submission.

Ask a specific question about this device

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.

Ask a specific question about this device