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The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Iniaging (MRI). The system does not expose the patient to ionizing radiation, only the dose contribution from the PET radiopharmaceutical. The MRI subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portions of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

Image processing and display work stations provide software applications to process, analyze, display, quantify and interpret medical images/data via a single user interface. The PET and MRI images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professional use the images in:

• The evaluation, detection and diagnosis of lesions, disease, and organ function . such as but not limited to cancer, cardiovascular disease, and neurological disorders.
• . The detection, localization, and staging of tumors and diagnosing cancer patients.
• Treatment planning and interventional radiology procedures. ♥

The device includes software that provides a quantified analysis of regional cerebral activity from the PET images.

The MRI provides capabilities to perform interventional procedures in the head, body, and extremities which may be facilitated by MR techniques, such as real time imaging, such procedures must be performed with MRI compatible instrumentation as selected and evaluated by the clinical user.

The Ingenuity TF PET/MR system combines the Philips Achieva MR (K063559) and the Philips GEMINI PET/CT (Raptor, K052640) technologies. The system utilizes the MR technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of the both technologies is enhanced with the ability to fuse the MR and PET images using Philips fusion viewer software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the MR and PET images and provides a means for a simplified review of the fused images.

Magnetic Resonance Imaging is a medical imaging technique that is based on the principle that certain atomic nuclei present in the human body emit a weak relaxation signal when placed in a strong magnetic field and excited by a radio signal at the precession frequency. The emitted relaxation signals are analyzed by the system and a computed image reconstruction is displayed on a video screen.

Positron Emission Tomography uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high resolution, three dimensional images of biochemical and metabolic processes of organs within the body.

The Ingenuity TF PET/MR system consists of two gantries integrating the MR scanner and the PET scanner, a patient table to support the patient, within the gantries, and a scanning console and viewing console at the operator's workstation.

The request asks for specific information regarding the acceptance criteria and study proving device meets acceptance criteria, based on the provided text. However, the provided text is a 510(k) summary for a PET/MR system, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance studies or specific acceptance criteria for AI algorithms.

Therefore, much of the requested information cannot be extracted from the given document as it pertains to AI/algorithm performance studies which are not described.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for an AI algorithm. It mentions:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: "Clinical data" is mentioned, implying real patient data, but details such as country of origin, retrospective or prospective nature are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified in the document.

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

Not specified in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. The document primarily focuses on demonstrating substantial equivalence of the new PET/MR system to existing predicate devices (PET/CT and MRI) based on image quality and the MRAC method, not on human reader performance with or without AI assistance.

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

This document describes a diagnostic imaging system, not a standalone AI algorithm. The performance evaluation mentioned ("acceptable image quality" and "MRAC method was validated") refers to the system as a whole.

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

For the MRAC method, the ground truth was established through "phantom, simulated and clinical data." The specific nature of "ground truth" for image quality equivalence is not detailed but would typically involve visual assessment by experts against established standards or predicate images.

8. The sample size for the training set

Not applicable. The document describes a medical imaging system, not a device whose performance is based on an AI algorithm that requires a training set.

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

Not applicable.

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