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This device is a diagnostic imaging system for that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages.

Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data.

The PET and CT 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 professionals 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.
· Radiation therapy treatment planning and interventional radiology procedures.

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

Cardiac imaging software provides functionality for the quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

This scanner is also intended to be used for diagnostic imaging and 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.

• 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 proposed Ingenuity TF is an integrated diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within head, body and total 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 utilized Time-of-Flight (ToF) technology for the PET reconstruction. CT is a medical imaging technique that uses Xrays to obtain cross-sectional images of the head or body. The system utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The CT component can be utilized by clinicians for lung cancer screening. As such, lung cancer screening has been added to the Ingenuity TF intended use. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease. The major subsystems of the PET/CT include the PET image reconstruction subsystem, the PET Data Acquisition subsystem, the CT Image reconstruction subsystem, the CT acquisition subsystem, the PET Gantry, the CT Gantry and the patient table. The system is suitable for all patients, infant through adult.

Here's a summary of the acceptance criteria and study information for the Ingenuity TF device based on the provided text, focusing on what is and isn't available for each point:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not include a direct table of specific acceptance criteria (performance metrics with pass/fail thresholds) and corresponding reported performance for the Ingenuity TF. Instead, it states that:

• Acceptance Criteria (Implicit): The device was designed to meet "established design input requirements," "user needs and intended use," and comply with "FDA recognized consensus standards."
• Reported Performance (General): Design Verification activities "demonstrate the Ingenuity TF meets the established design input requirements." "Design Validation of user needs and intended use was conducted via simulated use testing." "Traceability from requirements to test plans to test results confirmed... that design requirements were met."

The document focuses on demonstrating substantial equivalence to a predicate device rather than providing quantitative performance against specific acceptance criteria for standalone performance.

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

This information is not provided in the document. The text mentions "simulated use testing" and "clinical workflow validation," but does not specify the sample size of cases or the provenance (country, retrospective/prospective) of any test data.

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

This information is not provided. If an expert panel was used for simulated use testing or clinical workflow validation, their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for the Ingenuity TF. The document explicitly states: "The Ingenuity TF did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Intended Use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness." Therefore, an effect size of human readers' improvement with AI vs. without AI assistance is not reported.

6. Standalone Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly detailed as a separate clinical study. The device itself is a diagnostic imaging system (a PET/CT scanner), not an AI algorithm intended for standalone interpretation. Performance was assessed through non-clinical testing and comparison to a predicate device. The "Image Quality verification" mentioned under non-clinical testing would involve evaluating the image output itself, which is a form of standalone evaluation of the device's output quality.

7. Type of Ground Truth Used

For the non-clinical and simulated use testing mentioned, the type of "ground truth" would likely involve:

• Established Design Input Requirements: Compliance with specified technical and functional requirements.
• User Needs and Intended Use: Verified through simulated use.
• Consensus Standards: Compliance with international safety and performance standards (e.g., NEMA NU 2:2012 for PET performance, IEC 60601 series).

For any "Image Quality verification," ground truth might be derived from phantom studies with known properties or comparison against highly detailed reference images, but this is not explicitly stated. The document doesn't mention pathology, expert consensus on clinical cases, or outcomes data as direct ground truth for device acceptance.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This device is a PET/CT scanner, not an AI model that undergoes a typical training phase with a dedicated dataset. While it incorporates "software that provides a quantified analysis," the development of this software (its training, if any, for specific analytical tasks) is not detailed.

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

Since there is no mention of a training set for the device itself (as it's a hardware imaging system with integrated software), the method for establishing ground truth for a training set is not applicable/not provided.

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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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