(15 days)
The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
The C-PET Plus Imaging System is a Positron Emission Tomography (PET) system, a nuclear medical imaging system with capabilities to acquire, process, and display clinical images that can be utilized in both conventional, fixed installations or mobile environments. It is intended to produce attenuation and non-attenuation corrected images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the head, body, or total body for interpretation by medical personnel.
Acceptance Criteria and Study for the C-PET Plus Imaging System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document indicates that the device performance was measured in accordance with the NEMA-NU2 standard. However, specific quantitative acceptance criteria values from the NEMA-NU2 standard are not explicitly listed in the submission, nor are the detailed reported performance values for the C-PET Plus Imaging System directly presented in a table format.
Based on the available information, the acceptance criteria are implicitly met by adherence to the NEMA-NU2 standard. The summary states: "The device performance was measured in accordance with NEMA-NU2 standard," and the FDA's clearance implies that the device met the necessary performance expectations relative to its predicate.
Therefore, a detailed table cannot be constructed with the provided text due to the lack of specific numerical acceptance criteria and reported performance values.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation conducted under the NEMA-NU2 standard. NEMA-NU2 is a standard for measuring performance characteristics of PET scanners, typically involving phantom studies rather than patient data in the context of this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document indicates that the device is intended for "interpretation by medical personnel." However, for the NEMA-NU2 standard performance evaluation, no human "experts" are typically involved in establishing ground truth. NEMA-NU2 measures objective physical characteristics of the scanner (e.g., spatial resolution, sensitivity, uniformity, count rate performance) using phantoms with known properties.
4. Adjudication Method
For the NEMA-NU2 standard performance evaluation, adjudication methods are not applicable as the measurements are objective physical characteristics rather than subjective interpretations requiring consensus from experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or described. The evaluation focused on the physical performance of the imaging system according to the NEMA-NU2 standard, not on the improvement of human reader performance with or without AI assistance. The device predates the common integration of AI in medical imaging.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "System Performance Test/Summary of Studies" section explicitly states: "The device performance was measured in accordance with NEMA-NU2 standard." This describes the objective, standalone performance of the PET imaging system itself (the algorithm being the reconstruction software), without human interaction for the purpose of the performance measurements.
7. Type of Ground Truth Used
The ground truth used for the performance evaluation was based on the known physical properties of phantoms as defined by the NEMA-NU2 standard. This typically involves phantoms with known concentrations of radioisotopes, known dimensions, and known spatial arrangements, allowing for objective measurement of the scanner's ability to accurately represent these properties.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The C-PET Plus Imaging System is described as an "evolution of the features and functionalities" with "enhancements in image reconstruction and NEMA NU 2 calculation software." This suggests that the development involved engineering improvements to existing algorithms rather than a machine learning model requiring a distinct training set.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned for a machine learning model, this question is not applicable based on the provided text. The "enhancements in image reconstruction" likely refer to classical image processing and reconstruction algorithms tuned and validated against expected physical outputs rather than ground truth established through data labeling.
§ 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.