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The SIGNA PET/MR 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. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional 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 when performed with MR compatible devices, such as MR safe biopsy needles.

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 fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a detachable patient table and both the acquisition and processing workstations with associated software.

The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and a transmit/receive whole body radiofrequency coil. The system includes patient adaptable RF shimming capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisitions. The PET subsystem supports Time of Flight (ToF) coincidence detection. The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The modifications to this system include the MotionFree Brain software feature, which allows users the flexibility to correct patient head motion using the acquired PET data from the exam, without the need of external tracking devices, additional MR data, or other motion tracking data schemes.

The provided text describes the 510(k) summary for the GE SIGNA PET/MR system with a specific modification: the "MotionFree Brain" software feature. This feature aims to correct patient head motion in PET data without external tracking devices or additional MR data.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. However, it states that "Performance testing on phantoms as part of non-clinical testing demonstrated MotionFree Brain achieved performance claims for Quantitation, Temporal Resolution, and Spatial Accuracy." For clinical testing, the acceptance was based on reader preference and confirmation that the feature could be "used safely and effectively in a clinical setting."

Implicit Acceptance Criteria and Reported Performance (derived from text):

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not explicitly state the numerical sample size (number of cases or patients) used for the clinical test set. It mentions "randomly labeled cases."
• Data Provenance: The document does not specify the country of origin for the data. The study was described as a "retrospective blind study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: The document refers to "board-certified readers" (plural), indicating more than one expert. The exact number is not provided.
• Qualifications of Experts: The experts were "board-certified readers." No further details on years of experience or specific specializations (e.g., neuroradiologist) are given.

4. Adjudication Method for the Test Set

The document states: "The readers were blinded to feature use (e.g. whether feature was enabled or disabled), report case history, as well as to the assessments made by the other readers. The readers were asked to complete an assessment, including additional commentary, and report their preference on the pair of image series presented."

This describes a blinded read comparison where readers evaluated paired images (with and without the feature). The adjudication method primarily involved readers reporting their preference rather than a formal consensus or 2+1/3+1 type of adjudication. The text implies individual reader assessment and preference reporting, not a group adjudication to establish a "ground truth" through consensus for each case regarding motion correction per se.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

• MRMC Study: An "external reader evaluation study was performed for MotionFree Brain. The retrospective blind study involved board-certified readers who were asked to evaluate randomly labeled cases that were reconstructed with and without MotionFree Brain." This structure implies an MRMC design, where multiple readers evaluate multiple cases under different conditions (with/without AI assistance).
• Effect Size of Human Readers Improvement: The document does not quantify the effect size (e.g., AUC, sensitivity, specificity improvement) of how much human readers improved with AI (MotionFree Brain) assistance vs. without. It focuses on reader preference and overall safety/effectiveness conclusion.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes "Performance testing on phantoms" for "Quantitation, Temporal Resolution, and Spatial Accuracy." This can be considered a form of standalone performance evaluation for the algorithm's core functionality, as it assesses the algorithm's output (reconstructed image quality metrics) on controlled phantom data, independent of human interpretation for diagnostic tasks.

7. Type of Ground Truth Used

• For Phantom Testing: The ground truth was based on the known, controlled characteristics of the phantoms used, against which the "Quantitation, Temporal Resolution, and Spatial Accuracy" were measured.
• For Clinical/Reader Study: The "ground truth" was indirectly established through the comparative assessment and preference of experienced, board-certified readers. It's not a definitive clinical outcome (e.g., pathology, long-term follow-up) but rather a relative assessment of image quality and diagnostic confidence as perceived by experts when comparing images with and without motion correction. The study design focused on assessing the impact of the feature on the interpretability by clinicians, rather than establishing a true disease status for each patient.

8. Sample Size for the Training Set

The document does not provide any information about the training set size for the MotionFree Brain software feature. This information is typically proprietary and not included in a 510(k) summary unless specifically requested or deemed critical for demonstrating substantial equivalence. Given that the feature "derives head motion information from the PET data" and "measures and incorporates the rigid-body motion information into the PET reconstruction," it likely involves algorithmic processing rather than a purely deep learning approach requiring a massive labeled training set in the conventional sense, though validation or tuning would still involve data.

9. How the Ground Truth for the Training Set Was Established

Since no information on the training set (or its existence as a distinct "training set" in a machine learning sense) is provided, there is no description of how its ground truth was established. If the algorithm is rule-based or model-based rather than solely data-driven (e.g., deep learning), a "training set" with ground truth in the supervised learning sense might not be applicable. The description ("MotionFree Brain derives head motion information from the PET data... measures and incorporates the rigid-body motion information into the PET reconstruction, correcting the position of each coincidence event") suggests a more deterministic or model-based approach to motion correction.

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The SIGNA PET/MR 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. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional 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 when performed with MR compatible devices, such as MR safe biopsy needles. 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 GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient table and both the acquisition and processing workstations with associated software. The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and body coil. The system includes dual drive capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving device performance for the SIGNA PET/MR system (K163619).

Important Note: The provided document is a 510(k) premarket notification summary for a modification to an existing device (SIGNA PET/MR, K142098). Therefore, the information primarily focuses on demonstrating substantial equivalence of the modified features (MR Attenuation Correction) rather than a complete de novo study of the entire PET/MR system. As such, some specific details typically found in studies for novel devices, such as comprehensive stand-alone performance or MRMC studies for improved human reading, are not explicitly provided or may not be applicable in the same way.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document mentions "Sample clinical images" were used for qualitative and quantitative comparisons. However, a specific numerical sample size for this test set is not explicitly stated in the provided text.
• Data Provenance: Not explicitly stated. The document refers to "clinical images," but does not specify the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) for a medical device company, it's generally assumed to be clinical data relevant to human use, potentially from multiple sites.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not explicitly stated. The document does not detail how ground truth was established for the "sample clinical images" used for comparison, nor does it mention the number or qualifications of experts involved in this specific aspect of the testing for the modified features.

4. Adjudication Method for the Test Set

• Not explicitly stated. The document focuses on demonstrating compliance with quality assurance measures and comparative testing. It does not mention an adjudication method for a test set in the context of expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study is not mentioned. The submission describes "clinical tests" involving "sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology." This implies a comparison against the existing technology, but not necessarily an MRMC study with human readers assessing improvement with human-AI assistance. The focus is on the performance of the attenuation correction modification itself.

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

• Yes, implicitly. The reported performance relates to the "software-only features" and their engineering verification and validation ("Testing on unit level," "Integration testing," "Safety testing," "Simulated use testing"). The "qualitative and quantitative comparisons" of the modified MR Attenuation Correction also refer to the algorithmic performance in generating these corrections, independent of a human interpreting the final images. The comparative aspects focus on the technical output of the algorithm.

7. The type of ground truth used

• Regarding the "clinical tests" for the modified MR Attenuation Correction, the "ground truth" seems to be established through comparison to the predicate device's MR Attenuation Correction technology. The document states, "Sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology are included in this submission to support substantial equivalence of the modified features." This indicates the predicate's performance serves as the reference point for evaluating the new system's attenuation correction. It does not explicitly mention pathology or direct outcomes data being used as ground truth for this specific software modification.

8. The sample size for the training set

• Not explicitly stated. The document describes a software modification to an existing device. It discusses the development process using "Risk Analysis," "Requirements Reviews," and "Design Reviews" and then verification and validation testing. There is no mention of a separate "training set" in the context of machine learning model development. The focus is on demonstrating that the modified software behaves as intended and is substantially equivalent to the predicate.

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

• N/A. As no explicit "training set" for a machine learning model is mentioned, there is no information on how its ground truth was established. The document describes a development and testing process for software features, not the training of an AI model in the typical sense with labeled data.

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The SIGNA PET/MR 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, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images and/ or spectra, and displays the internal struction 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 when performed with MR compatible devices, such as MR safe biopsy needles. 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 fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient table and both the acquisition and processing workstations with associated software.

The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil, body coil and local surface RF coils based on those of the reference device Discovery MR750w 3.0T. The system includes dual drive capabilities. The SIGNA PET detectors have been modified from those of the reference device, the Discovery PET/CT 690, to allow them to be integrated into the bore of the MR. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. Similar to Discovery PET/CT D690, PET supports Time of Flight (ToF). SIGNA PET/MR software is based on a combination of Discovery MR750w with Discovery PET/CT 690 software. It is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The SIGNA PET/MR system and surface coil suite, the subject of this application, is substantially equivalent to the commercially available devices above with modifications made to integrate the two modalities together into a whole-body system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SIGNA PET/MR device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance data from a clinical trial. Therefore, specific numerical acceptance criteria and corresponding device performance metrics are not explicitly stated in this document.

However, based on the non-clinical and clinical tests mentioned, we can infer the intent of the acceptance criteria. The performance is reported in a qualitative manner, affirming compliance and confirming image quality.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document only states "Sample images from the SIGNA PET/MR were collected from multiple sites." It does not specify a numerical sample size for the test set used in clinical evaluation.
• Data Provenance: The data was collected "from multiple sites". The country of origin is not specified. Given it's a submission to the US FDA by a company based in the US (Waukesha, WI), it is highly probable that at least some, if not all, of the sites were in the USA, but this is not explicitly stated. The study was likely retrospective for the collected "sample images" to confirm image quality, though this is also not directly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document. It only mentions that the system is intended to be used by "appropriately trained health care professionals."

4. Adjudication Method for the Test Set:

• The document does not specify any adjudication method. It notes that "sample images... were collected... to confirm simultaneous diagnostic image quality," implying some form of expert review, but details on how disagreements or consensus were reached are absent.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study is not mentioned. The document describes clinical evaluation to "confirm simultaneous diagnostic image quality," which is a verification of functionality, not a comparative study of human reader performance with or without AI assistance. The device itself is a diagnostic imaging system, not an AI-assisted diagnostic tool that augments human interpretation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes, in spirit, the clinical evaluation focused on the standalone performance of the device (SIGNA PET/MR system) in producing diagnostic image quality. The "algorithm" here refers to the entire imaging system's capability to generate images, not a separate AI algorithm that interprets those images. The statement "Sample images... were collected... to confirm simultaneous diagnostic image quality" implies an evaluation of the system's output directly.

7. The Type of Ground Truth Used:

• The document states "to confirm simultaneous diagnostic image quality." This suggests the ground truth was likely expert consensus or qualitative assessment by healthcare professionals evaluating the diagnostic utility and clarity of the acquired images. It is not pathology, outcomes data, or a quantifiable "true" diagnostic outcome in the strict sense for individual cases.

8. The Sample Size for the Training Set:

• This information is not applicable and not provided. The SIGNA PET/MR system is a medical imaging hardware device combined with imaging software, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense of machine learning for classification or prediction. Its software functions (patient management, data management, scan control, image reconstruction, archival, and evaluation) are based on established engineering principles and prior device software, not iterative learning from a large training dataset.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable and not provided for the reasons stated in point 8.

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