(126 days)
The Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.
The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).
It is intended to be used in outpatient departments and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use.
The proposed device, Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as SpO2, PR, NIBP and TEMP continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.
The proposed device, Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Sathemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).
The Vital Signs Monitor V6 is intended to be used in outpatients and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard Reference) | Reported Device Performance (Vital Signs Monitor V6) |
|---|---|---|
| Temperature Measurement | ASTM E1965-98 (reapproved 2009) | Device complies with ASTM E1965-98 |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not explicitly state the specific sample size used for the clinical test of the Vital Signs Monitor V6. It only mentions that the clinical test was conducted "per ASTM E1965-98(reapproved 2009)."
- Data Provenance: The clinical test was conducted in People's Hospital in Zhuhai, indicating the data is from China. The document does not specify whether the data was retrospective or prospective, but clinical tests are typically prospective studies.
3. Number of Experts and their Qualifications for Ground Truth
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the temperature measurement test. For a clinical study following ASTM E1965-98, ground truth usually relies on highly accurate reference thermometers used by trained clinical personnel, but specific details are not provided here.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device performance against a standard, not on human reader improvement with AI.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was done for the temperature measurement of the Vital Signs Monitor V6. The clinical test evaluated the device's performance against the ASTM E1965-98 standard. This standard typically defines the accuracy requirements for infrared thermometers, meaning the device's temperature measurement algorithm and hardware were tested as a standalone system.
7. Type of Ground Truth Used
The ground truth for the temperature measurement test would have been established by comparing the device's readings to those of a highly accurate reference thermometer as mandated by the ASTM E1965-98 standard. This is a form of empirical measurement comparison against a validated reference.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This type of device (vital signs monitor for temperature) typically undergoes calibration and validation against standards rather than machine learning-style training using a distinct training set.
9. How Ground Truth for the Training Set Was Established
As no training set is described, there is no information on how its ground truth was established.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).