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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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GE PET/CT systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The systems are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions in patients of all ages. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning.

The systems can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging systems.

The Discovery™ PET/CT 710 Clarity Edition consists of a fully integrated 3D Positron Emission Tomography and multi-slice Computed Tomography scanner with all available CT diagnostic applications, except gantry tilt. Due to the overall length of the PET/CT. the patient table sits on a special base that drives the table between the PET and CT portions of the gantry. The PET/CT table is rated for a patient weight of 227 Kg (500 pounds) and the cradle travels up to 1700mm on standard systems, or up 2 meters on systems with the 2m scan range option.

Discovery™ PET/CT 710 Clarity Edition systems have a quantitation reconstruction method option called Q.Clear. This method iteratively reconstructs PET images to full convergence (Regularized Reconstruction) while maintaining acceptable image quality,

The provided text is a 510(k) Summary for the GE Discovery PET/CT 710 Clarity Edition, which is a submission to the FDA. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and either the same technological characteristics or different technological characteristics that do not raise new questions of safety and effectiveness.

This document does not describe a study involving acceptance criteria and device performance in the way a clinical trial or algorithm performance study would. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Discovery PET/CT 690) by comparing design, materials, energy sources, operating principles, technology, and compliance with standards.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not present in this type of submission.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence rather than presenting specific quantitative performance metrics against predefined acceptance criteria for the new "Clarity Edition" feature (Q.Clear). It states that the "Discovery Clarity Edition performs as well as currently marketed devices," but without specific metrics.

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

Not applicable or not provided. This 510(k) does not detail a "test set" in the context of an algorithm performance study. The substantial equivalence argument relies on comparing the device's technological characteristics and overall safety and effectiveness with the predicate, rather than a clinical study with a specific test dataset for a new feature like Q.Clear.

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

Not applicable or not provided. Ground truth establishment for a test set is specific to performance studies involving diagnostic accuracy or image quality assessment by human readers. This document does not describe such a study.

4. Adjudication Method for the Test Set:

Not applicable or not provided.

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:

Not applicable or not provided. An MRMC study is not mentioned. The device's new feature, Q.Clear, is an iterative reconstruction method, but its impact on human reader performance is not quantified in this submission.

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

Not explicitly detailed as a standalone performance study. The document describes the Q.Clear method as a "quantitation reconstruction method option" that "iteratively reconstructs PET images to full convergence (Regularized Reconstruction) while maintaining acceptable image quality." This implies an assessment of image quality, but no specific standalone algorithm performance metrics (e.g., SNR, contrast, resolution) or the study demonstrating them are provided in this summary.

7. The Type of Ground Truth Used:

Not applicable or not provided.

8. The Sample Size for the Training Set:

Not applicable or not provided. The Q.Clear method is a reconstruction algorithm, not a machine learning algorithm in the typical sense that would require a "training set." While such algorithms are developed and optimized using various datasets, this 510(k) summary does not provide details of such development.

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

Not applicable or not provided.

Summary of available information regarding the "study" (in the context of substantial equivalence):

The submission acts as the "study" by comparing the new device, Discovery PET/CT 710 Clarity Edition, to its predicate, Discovery PET/CT 690.

• Acceptance Criteria (Implied for Substantial Equivalence): The implicit acceptance criteria for this 510(k) submission is that the new device, including its Q.Clear feature, performs "as well as currently marketed devices" and introduces "no significant change in safety or effectiveness" compared to the predicate device.
• Reported Device Performance:
  • The new device "employs the same design, construction, materials, energy source, operating principles, and technology" as the predicate.
  • The Q.Clear method is "similar to existing iterative reconstruction methods except it is able to continue iterations to full convergence while maintaining image quality by using noise reduction."
  • Both systems are "compliant with the same IEC, NEMA and related safety and performance standards."
  • Both systems "use the same acquisition methods and attenuation correction methods."
  • "Discovery Clarity Edition performs as well as currently marketed devices."

In conclusion, this 510(k) summary provides a regulatory argument for substantial equivalence rather than a detailed scientific study with specific performance metrics against acceptance criteria for the new Q.Clear feature. The "study" is the comparison itself, aiming to show that the new device is as safe and effective as the predicate.

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