(90 days)
RADIAnalyzer™ is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. RADIAnalyzer™ is intended for use in catheterization and related cardiovascular specially laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.
RADIAnalyzer™ is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire™ Sensor and other External Pressure Transducer. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RADIAnalyzer™ Printer and/or PC with RADIView™ installed. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.
The provided text describes the regulatory clearance for the RADIAnalyzer™ device and details its function and intended use. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, sample sizes, data provenance, expert qualifications, or ground truth methods.
The document states that the RADIAnalyzer™ complies with voluntary standards and that quality assurance measures were applied, including:
- Requirements specification review
- Code inspection
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
It concludes that "The results of these measures demonstrate that the RADIAnalyzer™ is as safe, as effective, and performs as well as the predicate devices." This implies that the device was compared to predicate devices for safety and effectiveness, but no details of such a comparison (e.g., performance metrics, statistical analysis) are provided.
Therefore, I cannot populate the table or answer the specific questions you've posed based on the given input. The information required (acceptance criteria, study details, sample sizes, ground truth methodology, etc.) is not present in the provided 510(k) summary.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).