(53 days)
CONTEC08A Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.
The proposed device, CONTEC08A Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can be used on adult, pediatric, and neonatal individuals.
The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.
CONTEC08A has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, the device has technical alarm function which will be triggered when the battery voltage is lower than 3.9V, and this alarm can not be cancelled unless being closed or the power replaced.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CONTEC08A Electronic Sphygmomanometer are based on the ANSI/AAMI SP10:2002 & A1:2003 & A2:2006 standard for manual, electronic, or automated sphygmomanometers. While the specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text, the document confirms that "The test results demonstrated that the proposed device comply with the standard requirements and the accuracy the manufacture declared."
| Acceptance Criteria (Based on ANSI/AAMI SP10 Standard) | Reported Device Performance |
|---|---|
| Specific numerical accuracy criteria not provided in the text | Complies with the standard requirements and the accuracy declared by the manufacturer. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text.
- Data Provenance: The clinical test was conducted in Qinhuangdao Maternal and Child Health Hospital, China. This indicates a prospective clinical study conducted in China.
3. Number of Experts and Qualifications
Not explicitly stated in the provided text. The document mentions "clinical test following ANSI/AAMI SP10," but does not detail the involvement or qualifications of experts in establishing ground truth.
4. Adjudication Method
Not explicitly stated in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The provided text describes a clinical test for an automatic non-invasive blood pressure monitor, not a study evaluating human readers' performance with or without AI assistance.
6. Standalone Performance
Yes, a standalone performance evaluation was conducted. The clinical test evaluated the device's accuracy against the ANSI/AAMI SP10 standard. The device "can automatically complete the inflation, deflation and BP measurement," indicating its standalone capability.
7. Type of Ground Truth Used
The type of ground truth used is implied to be a reference standard for blood pressure measurement, as mandated by the ANSI/AAMI SP10 standard. This standard typically involves comparisons to auscultatory reference measurements performed by trained observers.
8. Sample Size for Training Set
Not applicable. This device is an automatic sphygmomanometer, and the description of its testing focuses on clinical validation rather than a machine learning model that would require a distinct training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning model.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).