(47 days)
IBP: The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial pressures using invasive transducers with 5uV/V/mmHg sensitivity for use with resting patients in critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only. TEMPERATURE: The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors.
ZOLL M Series IBP and Temperature Option
I am sorry, but the provided text from the FDA 510(k) summary for the ZOLL M Series IBP and Temperature Options does not contain the acceptance criteria or a study detailing the device's performance against those criteria.
The document is a clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use and contraindications but does not include any technical specifications, performance metrics, or study results related to sensitivity, specificity, accuracy, or other performance characteristics.
Therefore, I cannot provide the requested information in the table format or answer the questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information would typically be found in the more detailed 510(k) submission itself, which is not provided here.
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).