Search Results

The intended use of the Accutorr V is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The physiologic parameters measured includes: noninvasive blood pressure (NIBP), pulse oximetry (SpO2), pulse rate and temperature.

The Accutorr V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Accutorr V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Accutor V may be powered by a rechargeable Lithium ion battery or through line-power. The Accutorr V may be equipped with optional infrared or predictive temperature and recorder modules and may be mounted on an optional rolling stand for easy portability.

The provided text K091068 is a 510(k) Summary for the Accutorr V Monitor. This document does not contain the detailed study information regarding acceptance criteria and performance as requested. It states that "The Accutorr V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" and that a "risk analysis has been developed... The device's software has been verified and validated in accordance with the appropriate test requirements." However, it does not provide the specific acceptance criteria, reported device performance metrics, study details such as sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot populate the requested table and answer the study-related questions based on the information provided in K091068. The document serves as a summary for regulatory submission, rather than a detailed report of the performance studies.

Ask a specific question about this device