(11 days)
The device is a diagnostic imaging system for fixed or mobile installations 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). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.
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.
- Treatment planning and interventional radiology procedures.
The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets 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.
The device is a hybrid diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanners that can be utilized in fixed installations or mobile environments. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET), X-ray Computed Tomography (CT), a patient table, gantry separation unit, and the acquisition and processing workstations.
The provided text is a 510(k) summary for the "Gemini Raptor" device. It describes a hybrid diagnostic imaging system combining Positron Emission Tomography (PET) and X-ray Computed Tomography (CT).
However, the document does not include the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The "System Performance Test/ Summary of Studies" section only states that Philips adheres to recognized industry practices and complies with performance standards for ionizing radiation and electrical/mechanical safety (21 CFR 1020.30, 21 CFR 1020.33, IEC 60601-1 series, and NEMA-NU2 standard). It does not provide:
- A table of acceptance criteria and reported device performance.
- Details on sample size or data provenance for a test set.
- Information on expert qualifications or the number of experts used for ground truth.
- The adjudication method.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore,Based on the provided 510(k) summary, the requested information regarding acceptance criteria and specific study details for proving the device meets these criteria is not available.
The document states:
- Performance Standards: The device adheres to recognized and established industry practices and complies with performance standards for ionizing radiation emitting products (21 CFR 1020.30 and 21 CFR 1020.33), electrical and mechanical safety (IEC 60601-1 series), and the NEMA-NU2 standard for device performance measurement.
This indicates the device was tested against these general regulatory and industry standards, but it does not provide any specific quantitative acceptance criteria or the results of a study designed to demonstrate compliance with such criteria in the format requested.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, or training set details based on the provided text.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.