(57 days)
VERITON™ NM is a Nuclear Medicine (NM) imaging system, intended to perform general nuclear medicine imaging procedures for the detection of radioisotope tracer uptake in a patient's body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
Scanning modes include whole body and tomographic (static, dynamic and multi-gated) mode, while acquisition types include single and multi-isotope single-photon imaging-enhancement features include gating by way of physiological signals and real-time automatic body contouring.
The VERITON™ NM system is a medical device intended for use by appropriately-trained healthcare professionals to aid in the detection, localization and diagnosis of diseases and organ function, for the evaluation of diseases, trauma, abnormalities and disorders. System output can be used by a physician for planning, guiding, and monitoring therapy.
SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: whole body imaging and tomographic imaging.
Software: System application software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, CT and other imaging modalities.
Spectrum Dynamics VERITON™ NM system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the body and to produce cross-sectional images through computer reconstruction of the data.
The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The system may utilize various modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion).
The VERITON™ NM system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.
Here's a breakdown of the acceptance criteria and study information for the VERITON™ NM, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct table of specific numerical acceptance criteria and reported device performance for the VERITON™ NM. Instead, it states that:
- "All testing results have met the predetermined acceptance values."
- "Mathematical and physics analysis were performed to demonstrate that each performance metric/claim was successfully verified and substantiated."
- "The device has successfully completed all design control testing per our quality system. No new hazards were identified and no unexpected test results were obtained."
The document mentions that testing was conducted according to NEMA NU-1:2012. This standard specifies performance measurements for gamma cameras, and compliance implies meeting the criteria within that standard for the tested parameters.
Evaluated Areas (Implied Performance Metrics):
- Energy resolution
- Count rate linearity
- Uniformity
- System resolution
- Lesion detectability
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that the non-clinical performance evaluation testing "used a variety of test methods and phantoms appropriate for the performance metric/claim that was to be tested and evaluated."
- Sample Size for Test Set: Phantoms were used. The specific number or types of phantoms used for each test are not detailed in this summary.
- Data Provenance: This was an in-vitro (phantom-based) and non-clinical study. Therefore, there is no patient data or country of origin mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as the testing was performed using phantoms and engineering analysis, not human interpretation of patient data in an AI context. The "ground truth" for these tests would be the known physical properties and configurations of the phantoms.
4. Adjudication Method for the Test Set:
Not applicable, as the testing involved physical measurements and analysis against predetermined engineering and performance standards (NEMA NU-1:2012), not human adjudication of image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This document describes non-clinical performance testing of the imaging system itself, not a study of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
While the device includes "System application software is a display and analysis package intended to aid the clinician," the performance testing described here focuses on the imaging system's technical specifications and image quality using phantoms. It does not explicitly detail a standalone performance study of the algorithm's diagnostic capabilities on patient data. The summary is primarily about the hardware and core imaging performance.
7. Type of Ground Truth Used:
For the non-clinical performance testing, the ground truth was based on the known physical properties and configurations of the phantoms used, as well as established metrological standards (e.g., NEMA NU-1:2012).
8. Sample Size for the Training Set:
Not applicable. This document describes validation testing of the VERITON™ NM system, which is an imaging device (hardware and associated software), not an AI algorithm that requires a "training set" in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no "training set" in the machine learning sense.
§ 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.