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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 sys tem 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 obligue 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 label ing. This system may also be used for imaging during interventional procedures when 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-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The subject device, syngo MR E11P-AP01 system software for the Biograph mMR system, is a modification of the previously cleared predicate device Biograph mMR with syngo MR E11P system software (K163234, cleared February 28, 2017). The subject device has been modified to include the new mMR 32 Head coil for combined MR-PET usage as well as improvements to the system software syngo MR E11P.

• Improvement of the SPACE pulse sequence type with:
• CAIPIRINHA acquisition technique named as CAIPIRINHA o SPACE (migrated from previously cleared reference device K173592)
• Additional magnetization preparation mode "Non-sel. T2 prep. IR" o for brain imaging with improved dark-fluid contrast.
• Implementation of "CP-only" RF transmission mode based on the । requirements of 60601-2-33 Ed. 3.2:2015.

I am unable to conduct a detailed analysis of the acceptance criteria and study as the provided text is a 510(k) summary for a medical device (Biograph mMR with syngo MR E11P-AP01 system software) and does not contain the specific information required to complete your request.

Here's why and what's missing:

• No Explicit Acceptance Criteria: The document describes modifications to an existing device (software updates, new head coil). It states that nonclinical data "suggests that the feature bear an equivalent safety and performance profile as that of the predicate device." However, it does not define specific quantitative acceptance criteria for performance metrics (e.g., specific thresholds for image quality, signal-to-noise ratio, diagnostic accuracy, etc.) that the device must meet.
• No Detailed Study Results: While it mentions "nonclinical tests" were conducted and "clinical images are provided to support the migrated coil as well as the improved software features," it does not provide the results of these tests. It only makes a general statement that the device "performs as intended."
• Lack of Specifics for Your Questions: The text is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study report. Therefore, it does not include:
  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, or details about patient cohorts (e.g., country of origin, retrospective/prospective nature).
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
  • Details of standalone algorithm performance.
  • Specific types of ground truth used (beyond general "clinical images").
  • Sample size or ground truth establishment methods for training sets.

In essence, the document confirms that testing was done to ensure the modified device is substantially equivalent to its predicate, but it does not delve into the granular details of those tests, their results, or the precise acceptance criteria used, which would be found in a more comprehensive study report or internal validation documentation.

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