(104 days)
The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces crosssectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.
This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.
Celesteion, PCA-9000A/3, V6.4, is a large bore, TOF, PET-CT system, which combines a high-end CT system with a high-throughput PET system. The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 900 mm and a maximum scanning field of 700 mm. The highthroughput PET system has a time of flight (TOF) detector with temporal resolution of 450 ps. Celesteion, PCA-9000A/3, V6.4, is intended to acquire PET images of any desired region of the whole body and CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of positron emitting radiopharmaceuticals in the body with the obtained images. This device is used to gather the metabolic and functional information from the distribution of radiopharmaceuticals in the body for the assessment of metabolic and physiologic functions. This information can assist research, diagnosis, therapeutic planning, and therapeutic outcome assessment. This device can also function independently as a whole body multi-slice CT scanner.
The provided text is a 510(k) summary for the Celesteion, PCA-9000A/3, v6.4 medical device. It does not contain information about a study with acceptance criteria and reported performance in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device and outlines technical specifications and compliance with various standards.
Here's a breakdown of why this information is not present and what is discussed instead:
- Type of Submission: This is a 510(k) premarket notification for a modification to an existing device (Celesteion, PCA-9000A/2). The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. It generally doesn't require new clinical efficacy studies with specific acceptance criteria in the same way a PMA (Premarket Approval) would for novel devices.
- Focus of "Testing": The "Testing" section mentions "Risk analysis and verification/validation testing conducted through bench testing." This refers to engineering tests to ensure the device performs according to its specifications and complies with design controls and quality systems, not typically clinical studies to prove efficacy against acceptance criteria.
- Image Quality Metrics: It states, "Image quality metrics studies concluded that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and noise properties." This is a comparison to the predicate, not performance against predefined acceptance criteria in a clinical study.
- PSF Claims: "Additional bench testing was conducted to support PSF claims including improved contrast recovery, sharper point source in air, more uniform point size across the field of view, ringing artifact reduction, SUV increase and reduced reconstruction time." Again, these are technical performance improvements, likely measured against internal engineering benchmarks, not clinical acceptance criteria established for a patient outcome study.
- Standards Compliance: Much of the "testing" described involves adherence to international standards (IEC, NEMA), which ensures safety and basic performance, but doesn't usually involve clinical acceptance criteria of the type requested.
- Software Documentation: Mentions software documentation for a "Moderate Level of Concern," which related to software validation, not a clinical study.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth, or MRMC studies because the provided document does not contain this information. The document confirms that the device is a modified PET-CT system and that changes (like a new CT detector, metal artifact reduction software, PET respiratory gating, and PSF correction) do not affect "safety or efficacy" as demonstrated through "performance testing" and comparison to a predicate device. This is typical for a 510(k) submission.
§ 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.