3.1. Pre-delivery 3.1.2 Parameter Actor Requirement Release Testing Manufacturer The camera (and any replacements parts) must pass all manufacturing in-process and release testing criteria Non-OEM parts supplier All parts and accessories must meet or exceed OEM specifications and pass all release testing criteria DICOM format Manufacturer Shall meet the Conformance Statement written by manufacturer of each system Computer workstations Vendor All workstations used to process images must be validated, able to support the image file type generated by the gamma camera and able to perform the image reconstruction and analysis requirements detailed in Sections 3.7 and 3.10. Camera System Owned by imaging center; placed by technologist A camera system should be used that meets the requirements detailed under Image Data Acquisition in Section 3.6. This includes specific requirements for the collimator, projection bin (pixel) size, head-holder, etc. 3.2 INSTALLATION AND 3.2.2 trial
guidance document and should be applied as appropriate. Parameter Specification Phantom tests: Frequency Imaging Site Shall perform and document results of all tests no less than quarterly, and always after scanner upgrades, and repairs or recalibration of the gamma camera motions and/or detectors Phantom Planar Uniformity Imaging Site Uniformity of response to a uniform flux of radiation from a I-123 point source shall be measured intrinsically every quarter. On a daily basis planar uniformity with collimators used for I-123 imaging should be performed using a Tc-99m or Co-57 source System Spatial Resolution Physicist Tests the resolution of the system in terms of the FWHM of its point spread function. Test should be conducted semiannually with the collimators routinely used with 123I ioflupane studies. The result of the test should be less than 8 mm at 10 cm. Phantom tests: transaxial uniformity measurement Imaging Site Using a uniform cylinder filled with I-123, obtain a within slice variability of less than 5%. Phantom tests: suitability for basal ganglia imaging Imaging Site Using an anthropomorphic phantom with basal ganglia and reference region background compartments filled at a homogeneous striatal ratio of 4.5:1, to distinguish the caudate nuclei and putaminal, and also with a caudate/putamen gradient of 4.5:1 caudate, 2.25:1 putamen to assess systems ability to determine an uptake gradient across the striata Phantom test: Imaging Site noise in the reference region/background compartment. The COV of the volume of interest thus determined should be recorded and should be below 15%. Phantom test: data acquisition Imaging Site Shall acquire according to Section 3.6 Phantom test: data reconstruction Imaging Site reconstruct according to Section 3.7 Phantom test: data analysis Imaging Site Shall ensure noise is less than specified above. 3.9. Image Distribution This activity describes criteria and procedures related to distributing images that are necessary to reliably meet the Profile Claim.
Parameter Actor Requirement Place VOI Technologist or image analysis specialist For SBR, cause to have placed volumes of interest (VOI) on structures of interest and appropriate reference tissue. VOIs include caudate, anterior putamen, and posterior putamen on each side of brain. Calculate measurand Technologist or analysis specialist calculate time-point measurand (SBR or %dose/mL) Certify VOI Qualified physician Shall either (1) agree with region boundaries, (2) reject boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. Certify measurand Qualified physician Shall either (1) agree with region boundaries, (2) reject boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. classification Qualified physician Claim 1: interpret measurand as consistent with, or not consistent with, Parkinson’s disease. Claim 2: interpret measurand a consistent with a value of X +/- y, where x is the measured value, and y is the confidence interval described in Section 2 under Claim 2 Claim 3: interpret the measurand as consistent with, or not diagnostic of, change greater than the Repeatability Coefficient (RC) described above 4. Assessment Procedures