(90 days)
QuantEM™ package is a renal analysis package for Tc-99m MAG3 renal images. The QuantEM™ method was developed at Emory University, Atlanta, GA for calculating the clearance of Tc-99m MAG3. It provides a comprehensive package consisting of processing and protocols to aid the technologist and physician in the performance and interpretation of Tc99m MAG3 renograms
The QuantEM™ package is implemented on the Apex XPert workstation of the Varicam gamma camera (K953801).
This document does not contain the information requested regarding acceptance criteria, study details, or performance metrics.
The provided text is a Summary of Safety and Effectiveness for the K963162 premarket notification. It states that the QuantEM™ package on the Apex XPert workstation is "substantially equivalent" to previous versions of the QuantEM™ package on GE Starcam computers (K932957) and the Apex XPert workstation (K953801).
Here's why the requested information is not present:
- No Acceptance Criteria or Performance Data: The document makes a claim of "equivalence" but does not define specific acceptance criteria or provide any quantitative study data to demonstrate that equivalence. It states that "validation and tests were made to ensure correct processing results," but the details of these tests, their acceptance criteria, or the actual results are not included.
- No Study Details: There's no mention of sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This is typical for a substantial equivalence claim where a new device is compared to a legally marketed predicate device without necessarily requiring new clinical performance studies if the technological characteristics and intended use are similar enough.
Therefore, I cannot populate the table or answer the specific questions based on the provided input. The document focuses solely on establishing substantial equivalence in regulatory terms rather than detailing a performance study.
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Summary of Safety and Effectiveness
QuantEM™ package is a renal analysis package for Tc-99m MAG3 renal images. The QuantEM™ method was developed at Emory University, Atlanta, GA for calculating the clearance of Tc-99m MAG3. It provides a comprehensive package consisting of processing and protocols to aid the technologist and physician in the performance and interpretation of Tc99m MAG3 renograms
The QuantEM™ package is implemented on the Apex XPert workstation of the Varicam gamma camera (K953801).
The effectiveness of the QuantEM"" package, implemented on the Apex XPert, is equivalent to the effectiveness of the QuantEM™ package implemented on GE Starcam computers (K932957).
The addition of the QuantEM1" package does not effect the safety and effectiveness of all other functions performed by the Apex XPert workstation.
Precautions to avoid erroneous processing results were taken and the necessary validation and tests were made to ensure correct processing results of the QuantEM™ package.
Based on the above, it is Elscint's opinion that the XPert QuantEM™ package usage is substantially equivalent in safety and effectiveness to QuantEMTM package on General Electric nuclear medicine computers (K932957), and that the Apex XPert workstation equipped with the QuantEM*** package is substantially equivalent in safety and effectiveness to the previously marketed version of the Varicam's Apex XPert workstation (K953801),
§ 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.