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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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ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the ARTIS family include cardiac angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image-guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.

ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.

The ARTIS family include also the software option DynaCT with following indications for use:

DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The ARTIS pheno is a further development of the Artis Q and Artis Q.zen -Modular Angiography System. ARTIS pheno is equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table, and image post processing. syngo Application Software is optional available for the support of dedicated clinical workflows.

The provided text describes the ARTIS pheno device and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The document states that "Non-clinical tests were conducted for ARTIS pheno, during product development" and that "The modifications described in this Premarket Notification were supported with verification and validation testing." It also mentions "The performance data demonstrates continued conformance with special controls for medical devices containing software" and "The testing results support that all the software specifications have met the acceptance criteria."

However, it does not provide the actual acceptance criteria or the specific numerical performance results achieved by the device in a table format. It only lists various standards the device complies with (e.g., ES60601-1:2005/(R)2012) and general statements about the tests being passed.

Therefore, I cannot populate the requested table or provide detailed answers to questions 2 through 9 based on the provided text. The document refers to "non-clinical performance testing" and "verification and validation testing" but does not elaborate on the specific methodologies, sample sizes, ground truth establishment, or expert involvement for these tests.

Summary of available information regarding performance:

• Acceptance Criteria/Reported Performance: Not explicitly stated in a quantifiable manner or table. The document generally states that "all tests were passed" and that "all the software specifications have met the acceptance criteria."
• Sample size for test set and data provenance: No information provided.
• Number of experts and qualifications for ground truth: No information provided.
• Adjudication method: No information provided.
• MRMC comparative effectiveness study: No information provided.
• Standalone (algorithm only) performance: No information provided the software is a component of the interventional fluoroscopic x-ray system, not a standalone AI device with specific algorithmic performance metrics.
• Type of ground truth used: "Non-clinical performance testing" and "software specifications" are mentioned, suggesting internal validation against defined functional requirements and safety standards. No mention of expert consensus, pathology, or outcomes data for performance evaluation in the context of diagnostic accuracy.
• Sample size for training set: No information provided.
• How ground truth for training set was established: No information provided.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, adherence to safety and performance standards for an interventional fluoroscopic x-ray system, and successful completion of verification and validation activities. It does not provide the kind of detailed study results one might expect for a novel AI/CAD device.

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