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The uMI Panorama is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.

This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

The proposed device uMI Panorama combines a 280 or 350 mm axial field of view (FOV) PET and 160-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET system. CT system, patient table, power distribution unit, control and reconstruction system (host, monitor, and reconstruction computer, system software, reconstruction software), vital signal module and other accessories.

The uMI Panorama has been previously cleared by FDA via K223325. The mainly modifications performed on the uMI Panorama (K223325) in this submission are due to the algorithm update of uExcel Focus (also named OncoFocus) and the addition of uKinetics. This time, uExcel Focus adds deep learning technology based on the original technology and could be performed as intended. uKinetics is a new function. which is used to generate both indirect and direct parametric images.

The provided text describes a 510(k) summary for the uMI Panorama PET/CT system, with specific modifications related to the uExcel Focus and uKinetics features. While it outlines general performance evaluations, it does not contain the detailed, quantitative acceptance criteria and the full study data typically found in a clinical study report. It primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer some details and present them in the requested format, clearly indicating where implicit understanding or lack of specific data exists.

Here's an attempt to extract and structure the information as requested, with explicit notes about missing details:

Acceptance Criteria and Device Performance for uMI Panorama (uExcel Focus and uKinetics updates)

The performance data provided primarily aims to demonstrate substantial equivalence to the predicate device (uMI Panorama K223325) for specific new features: uExcel Focus and uKinetics. The studies performed were "bench tests" and a "clinical image evaluation."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in numerical thresholds but rather describes the intended outcome of the features. The "reported device performance" are qualitative statements about the observed effects.

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

• Sample Size (Test Set): Not explicitly stated. For uExcel Focus, "images were compared," and for uKinetics, "Bias of area under curve (AUC) of the estimated image-derived input function (IDIF)" and "Bias of Ki and intercept in the hot spheres in the IO phantom" and "Coefficient of variation (CoV) of the background region in the IQ phantom" were assessed. This suggests phantom data for verification. The "clinical image evaluation" involved two physicians evaluating "images," but the number of patient cases or images is not provided.
• Data Provenance: Not explicitly stated. The manufacturer is based in Shanghai, China. The nature of the "clinical image evaluation" (retrospective or prospective) is not specified, but it implies real patient data. Phantom data is generated in a controlled environment.

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

• Number of Experts: For the "Clinical Image Evaluation" of uExcel Focus, Two American board-certified nuclear medicine physicians were involved.
• Qualifications of Experts: "American board-certified nuclear medicine physicians." No specific experience duration (e.g., "10 years of experience") is mentioned.

4. Adjudication Method for the Test Set

• For the "Clinical Image Evaluation" of uExcel Focus, the physicians evaluated images "independently." The document does not specify an adjudication method (e.g., 2+1, 3+1, consensus reading by a third party if there was disagreement). It merely states they evaluated independently.

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

• No, a formal MRMC comparative effectiveness study, as typically understood for quantifying human reader improvement, was not explicitly described. The "Clinical Image Evaluation" was a "blind comparison" where two nuclear medicine physicians independently evaluated images from the uMI Panorama with/without uExcel Focus. This setup is a prerequisite for an MRMC study, but the document only reports a qualitative conclusion ("sufficient for clinical diagnosis," "can reduce artifacts and improve alignment") rather than a statistical analysis of reader performance improvement (e.g., AUC, sensitivity, specificity) with AI assistance versus without.
• Effect Size of Human Reader Improvement: Not reported.

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

• The performance descriptions for both uExcel Focus (e.g., "reduce respiratory motion effects and improve the accuracy of SUV and lesion volume") and uKinetics (e.g., "provide quantitatively accurate parametric images") appear to describe the algorithm's inherent performance as measured through "bench testing" (which often involves phantoms or simulated data) or direct analysis of image metrics.
• Thus, yes, aspects of standalone performance were evaluated for both features, particularly uKinetics which focuses on quantitative accuracy of derived parameters. uExcel Focus also had non-clinical tests verifying its effects on SUV and volume accuracy.

7. The Type of Ground Truth Used

• For uExcel Focus (non-clinical/bench testing): The ground truth metrics were likely derived from known phantom configurations where true SUV, lesion volume, and motion scenarios are controlled or modeled to allow for comparison against system output (e.g., known phantom dimensions and activity concentrations).
• For uKinetics (non-clinical/bench testing): Ground truth was based on phantom properties (e.g., "hot spheres in the IO phantom," "background region in the IQ phantom") and potentially theoretical or simulated models for IDIF, Ki, and intercept values given known input.
• For uExcel Focus (clinical image evaluation): The "ground truth" for clinical sufficiency and artifact reduction appears to be expert consensus/opinion by the two American board-certified nuclear medicine physicians, rather than pathology or long-term clinical outcomes data. They judged if the images were "sufficient for clinical diagnosis."

8. The Sample Size for the Training Set

• Not provided. The document states that uExcel Focus "adds deep learning technology based on the original technology," which implies the use of a training set. However, the size and characteristics of this training set are not disclosed in this 510(k) summary.

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

• Not provided. Given the use of deep learning for uExcel Focus, a method to establish ground truth for training data would be crucial (e.g., expert annotations, simulated data, or other validated methods). This detail is not included in the provided text.

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The Siemens Biograph Horizon PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and re staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

This CT system can be used for low dose lung cancer screening in high risk populations.*

• As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Biograph Horizon PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph Horizon software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The software for the Biograph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include, corrections to software anomalies and addition of new software features, including:

• OncoFreeze
• OncoFreeze AI (Data Driven Gating)
• CardioFreeze
• FlowMotion Multi-Parametric PET AI ●
• PET FAST Planning (FlowMotion Al)
• FAST PET Workflow
• QualityGuard
• . Updates to HD FoV
• Updates to PET DICOM dose Report
• Whole Body Scatter Correction

Additionally, minor modifications have been made to the computers due to obsolescence issues and to the controllers of the PHS for cost improvement. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

The Siemens Biograph Horizon PET/CT system (K193178) underwent performance testing against NEMA NU2-2018 standards for its PET subsystem. The device also had specific evaluations for new software features: OncoFreeze AI, OncoFreeze/CardioFreeze, FlowMotion Multi-Parametric PET AI, FlowMotion AI (PET FAST Planning), QualityGuard, and Whole Body Scatter Correction.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• PET Testing (NEMA NU2-2018): The document implies physical phantom testing which is standard for NEMA NU2-2018. The number of samples (scans or measurements) from the phantom is not explicitly stated, but these tests are typically performed on two different configurations: a 3-ring version and a 4-ring version (TrueV). Data provenance is from physical phantom measurements on the device itself.
• OncoFreeze AI (Data Driven Gating): The document mentions "motion-corrected (OncoFreeze) images comparing Anzai based gating and deviceless gating." It does not specify the number of patient images or specific phantom studies. The provenance isn't explicitly stated as retrospective or prospective, nor a country of origin.
• FlowMotion AI (PET FAST Planning): No specific sample size (i.e., number of cases or scans) is given. The study evaluated "configuration set" effectiveness. The provenance is not explicitly stated.
• Whole Body Scatter Correction: This was a "simulation study of phantom." The sample size (number of ROIs or simulation runs) is not specified. Provenance is simulation data based on a phantom.

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

• For the NEMA NU2-2018 PET testing, the ground truth for performance metrics (resolution, sensitivity, scatter fraction, image quality) is established by the known physical properties and activity concentrations of the NEMA phantom according to the standard. No human experts are involved in establishing this ground truth.
• For OncoFreeze AI, the "ground truth" for motion correction comparison is implicitly the static image or the Anzai-based gated images acting as a reference for comparison of SUV and Volume changes. No explicit expert involvement for ground truth is mentioned.
• For FlowMotion Multi-Parametric PET AI, the "ground truth" for improved noise characteristics and delineation is a comparison against the Patlak transformation performed during reconstruction without the automatic feature. This implies qualitative assessment, but no expert details are given.
• For FlowMotion AI (PET FAST Planning), the "ground truth" for correctly defined bed ranges would be based on the known or intended bed ranges. No expert involvement in establishing this ground truth is mentioned.
• For QualityGuard, the "ground truth" for time savings and exposure reduction would be direct measurement or comparison to previous workflows. No expert involvement for ground truth is mentioned.
• For Whole Body Scatter Correction, "ground truth" was established by a "simulation study of phantom," implying that the true values for activity in different regions of interest were known from the simulation setup. No human experts are involved in establishing this ground truth; it's inherent to the simulation.

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

No adjudication method for expert review of images or data is mentioned for any of the tests described. The tests are primarily technical performance evaluations (NEMA standards, quantitative comparisons, simulation studies) or workflow efficiency observations.

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 multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance is mentioned in the provided text. The AI features mentioned (OncoFreeze AI, FlowMotion Multi-Parametric PET AI, FlowMotion AI (PET FAST Planning)) are related to image processing and workflow automation rather than direct diagnostic assistance for human readers in a comparative effectiveness setting.

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

The device itself is a diagnostic imaging system (PET/CT), not an AI algorithm that provides a diagnostic output to a human. The AI features described within the device, such as OncoFreeze AI and FlowMotion AI, are designed to improve image quality, correct for motion, or automate planning. The performance metrics focus on the output of these features (e.g., changes in SUV, bed range identification accuracy, scatter correction accuracy) as part of the overall imaging system's functionality. Therefore, these features are evaluated in a standalone manner within the machine's operation, without explicit human-in-the-loop performance studies described here.

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

• NEMA NU2-2018 PET testing: Physical phantom with known activity concentrations and physical dimensions.
• OncoFreeze AI: Comparison to static images and Anzai-based gating, which implicitly serve as a reference or "ground truth" for the motion-corrected measurements.
• FlowMotion Multi-Parametric PET AI: Comparison to non-automated Patlak transformation results.
• FlowMotion AI (PET FAST Planning): Known or intended bed ranges from the configuration setup.
• QualityGuard: Measured time and staff exposure.
• Whole Body Scatter Correction: Known values from a "simulation study of phantom."

In summary, the ground truth types are primarily known physical properties of phantoms (or simulated phantoms), comparative measurements against established methods, or direct measurements of efficiency/safety.

8. The sample size for the training set:

The document does not provide any information about the training set size for the AI features (OncoFreeze AI, FlowMotion AI).

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

Since no information on training sets is provided, there is also no information on how ground truth for any training sets was established.

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The Siemens Biograph Vision PET/CT systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray wansmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.

These systems are intended to be utilized by approxiately trained health care professionals to aid in detecting. diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lune Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Biograph Vision systems are combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations.

The Biograph Vision systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph Vision software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The Biograph Vision PET/CT, which is the subject of this application, is substantially equivalent to the commercially available Biograph Vision PET/CT (K180811). The key differences between the current Biograph Vision (predicate device) and the Biograph Vision PET/CT that is the subject of this application is the addition of two new models (Biograph Vision 450 and Biograph Vision 450 Edge) with a smaller axial PET Field of View, as well as additional software modifications to daily / weekly Quality Control that is applicable to all models of the Biograph Vision.

The provided text describes the acceptance criteria and performance of the Siemens Biograph Vision PET/CT system, which is a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner. This is a 510(k) premarket notification for a medical device; therefore, the "study" proving acceptance is primarily a technical performance evaluation against established industry standards and comparison to a predicate device, rather than a clinical trial with human subjects for AI assistance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The performance testing for the PET component was conducted in accordance with NEMA NU2:2018.

Device: Biograph Vision PET/CT (specifically models 450/450 Edge and 600/650 Edge are mentioned, performance results are generic for both where ranges are the same, or specific to each model where they differ).

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