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The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

The MR is intended to produce transverse, sagittal, coronal and oblique crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures wen performed with MR compatible devices, such as MR safe biopsy needles.

The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fissed PET and MR images due to precisely aligned MR and PET image coordinate systems.

The new mMR Angio Transfer Option is being introduced for the Biograph mMR system.

The new option is intended to provide a patient transfer from the SIEMENS Artis Q and Artis Q.zen (K123529) or Artis zee/zeego SW VC21 (K141574) System to the Biograph mMR and vice versa.

To achieve this functionality a Transferboard Artis (further named as Transferboard) will be used where the patient is located and transferred. This Transferboard can be adapted on the standard table of the Artis Q and Artis Q.zen (K123529) or Artis zee/zeego SW VC21 (K141574) System. The standard table is identical for all models. By swiveling the Artis Q. Artis Q.zen or Artis zee /zeego table (standard function) the Transferboard will be positioned in front of the Biograph mMR. Via the Guiding Slide Way the Transferboard is pushed manually on the Table Top of the Biograph mMR.

The Guiding Slide Way is also included in the option and is installed on the Table Top of the Biograph mMR instead of a regular patient cushion.

The Transferboard is also used to move the patient into the bore of the Biograph mMR for further diagnostic imaging.

The basic device and its functionality remain unchanged except for the following modifications:

• . Coil Adapter Cover (CAC): The Coil Adapter Cover will replace the standard mMR coil adapter cover on the foot end of the mMR tabletop to enable the overtraveling of the Transferboard (TFB).
• Guiding Slide Wav (GSW): A Guiding Slide Way (GSW) will be adapted on the ● existing Biograph mMR tabletop. This is a foldable option and can be removed for diagnostic mMR examination in case the transfer option is not needed.
• Transferboard (TFB): The Transferboard (TFB) is intended to transfer the ● patient. The patient remains on this board during the whole intraoperative procedure.
• Patient Cushion (LGH): The Patient Cushion is laid on the Transferboard (TFB) for comfortable reclining.
• Fixation Belts: The Fixation Belts are used for preventing the patient to fall of ● the Transferboard and Patient Cushion during transport, surgery and imaging,
• Transfer Support Cart (TSC): The Transfer Support Cart is part of the option. ● It ensures that both tables have the same height and that there are no vibrations during transfer due to load changes on the patient tables

The new mMR Angio Transfer Option for the Biograph mMR system requires the most recent Device Software, syngo MR E11P software cleared via 510(k) on February 28, 2017 (K163234).

This document describes a 510(k) premarket notification for the "Biograph mMR with mMR Angio Transfer Option." This submission primarily addresses changes related to a patient transfer system, not a software algorithm for disease detection or diagnosis. Therefore, much of the information typically requested for AI/ML device studies (such as diagnostic performance metrics, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies) is not applicable or present in this document.

The acceptance criteria and "study" mentioned here relate to the safety and performance of the mechanical and electrical modifications that enable patient transfer between imaging systems.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This submission doesn't involve a test set of medical images or patient data for diagnostic performance evaluation. The "testing" refers to non-clinical performance evaluations of the mechanical and electrical components of the transfer option.
• Data Provenance: Not applicable. The "data" comes from engineering tests and evaluations of the new mechanical components and their integration with the existing Biograph mMR system, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no diagnostic "ground truth" or expert review of image data described, as this is not a diagnostic AI/ML device submission. The verification and validation were engineering-focused.

4. Adjudication method for the test set

• Not applicable for the reasons stated above.

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, an MRMC comparative effectiveness study was not done. This device is an imaging system enhancement for patient transfer, not an AI diagnostic tool.

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

• Not applicable. This device is not an algorithm for standalone performance evaluation.

7. The type of ground truth used

• Not applicable. The "ground truth" for the non-clinical performance testing would be the engineering specifications and safety requirements defined by the referenced standards (e.g., proper mechanical function, electrical safety thresholds, risk mitigation effectiveness).

8. The sample size for the training set

• Not applicable. There is no machine learning component or training set involved in this submission.

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

• Not applicable. There is no machine learning component or training set involved in this submission.

In summary: This FDA filing (K172531) is for a modification to an existing medical imaging system (Biograph mMR) that introduces a new patient transfer option. The "study" and "acceptance criteria" discussed are related to the engineering and safety performance of these physical modifications, ensuring they meet recognized medical device standards (e.g., IEC, ISO) and do not negatively impact the safety or effectiveness of the original device. This is a typical submission for mechanical or electrical modifications to existing hardware, not for a new AI/ML diagnostic software as the questions largely imply.

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The MAGNETOM systems described above are 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/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

The MAGNETOM systems described above 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, software syngo MR E11A for MAGNETOM Aera and MAGNETOM Skyra offers two new applications, LiverLab (an application of non-invasive liver evaluation) and MyoMaps (an application designed to provide a means to generate pixel maps for myocardial MR relaxation times). In addition, software syngo MR E11A makes the Dot Cockpit available for the user to modify and create Siemens Dot Engine workflows in a very intuitive way which supplements some of the support of an application specialist. The software syngo MR E11A also includes new and modified sequences as well as minor modifications of already existing features. In additional coils are offered and some hardware components have been modified.

Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A offers additional capabilities with respect to the predicate device, the MAGNETOM Aera and MAGNETOM Skyra have the same technological characteristics as the predicate device (K121434; Cleared November, 5, 2012).

Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new configuration of the MAGNETOM Skyra with 24 receive channels with software syngo MR E11A.

The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration with 24 receive channels will be offered as an ex-factory option (new production).

This FDA 510(k) summary describes a new software version (syngo MR E11A) for existing Siemens MAGNETOM Aera and MAGNETOM Skyra MRI systems. The primary focus of the document is to demonstrate substantial equivalence to previous versions and other cleared devices, rather than establishing new acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, device performance, and specific study details (like sample size for test sets, expert qualifications, and adjudication methods) is largely not present for the overall system or its new features as this is an equivalence submission. The closest equivalent to "acceptance criteria" are the results of performance tests demonstrating the device performs as intended and is "substantially equivalent."

However, I can extract the available information regarding testing for the new features:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• MyoMaps Comparison Study:
  • Sample Size: 100 persons.
  • Data Provenance: Not specified, but involved "volunteers."
• LiverLab Validation:
  • Sample Size: Not specified beyond "volunteer" and "phantom scans."
  • Data Provenance: Not specified, beyond "volunteer" and "phantom scans" and "synthetic raw data."
• New Coils, Sequences, Algorithms, Acoustic Noise: Sample sizes not specified; phantom testing mentioned.
• Clinical tests (overall device): No clinical tests were conducted to support the substantial equivalence argument beyond the provision of clinical images to support new coils and software features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. The document states that the images and spectra, "when interpreted by a trained physician, yield information that may assist in diagnosis." However, for validation studies, the specifics of expert involvement or ground truth establishment are not detailed.

4. Adjudication method for the test set

• This information is not provided in the document.

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

• A MRMC study comparing human readers with and without AI assistance was not mentioned or performed as part of this submission. The "MyoMaps" feature was compared to "Thalassaemia Tools," which is a comparison of two tools, not a human-AI comparison.

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

• The document describes "LiverLab" validation using "volunteer as well as phantom scans, and synthetic raw data" and "MyoMaps" being "tested on volunteers." This suggests standalone performance evaluation for these specific features. However, detailed metrics of standalone performance are not provided, only that the "results... demonstrate that the device performs as intended."

7. The type of ground truth used

• MyoMaps: The comparison was against "Thalassaemia Tools." For the "volunteers" testing, the method of establishing ground truth for myocardial MR relaxation times beyond direct measurement is not specified.
• LiverLab: Validation involved "volunteer as well as phantom scans, and synthetic raw data." The ground truth for phantom scans would be known parameters. For volunteer scans, the ground truth source for liver evaluation is not explicitly stated (e.g., biopsy results, clinical diagnosis).
• For other features (coils, sequences), the ground truth generally relies on physical measurements and expected image properties.

8. The sample size for the training set

• This information is not provided in the document. The submission focuses on verification and validation of implemented features rather than detailing the development or training of algorithms.

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

• This information is not provided in the document. Given that details on a training set are absent, the method for establishing its ground truth is also not mentioned.

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