(308 days)
The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.
This device can be used to measure blood pressure and pulse rate non-persistently using the Korotkoff sound method of measuring blood pressure in vitro. The user can measure the blood pressure using this device and cuff, stethoscope. Basically, it has the same function as a conventional mercury sphygmomanometer. However, instead of using harmful mercury to the human body, it displays the pressure on the LCD screen, so that the blood pressure can be measured harmlessly to the human body. In addition, using the 'Mark' function can conveniently display the systolic and diastolic pressures. And using its backlight, the user can measure blood pressure in the dark place. If air pressure exceeds 320mmHg, it will automatically exhaust quickly. If an emergency occurs during the measurement, pressing On/Off button will turn off the equipment and allow rapid exhaust. The device is for use by medical professional. The testing person supplies their own stethoscope, which is required for making the measurements.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pressure Accuracy | ±3 mmHg |
| Pulse Accuracy | ±3% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 102 subjects
- Data Provenance: Not explicitly stated, but the study was performed by InBody, implying internal testing. The documentation does not specify the country of origin of the data.
- Retrospective/Prospective: Not explicitly stated, but given it's a bench testing procedure to verify accuracy, it would typically be a prospective study.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The document states "using the stethoscope," implying trained individuals capable of listening for Korotkoff sounds. However, no specific qualifications (e.g., radiologist, years of experience) are provided for these individuals.
4. Adjudication Method
- Adjudication Method: Not applicable/not specified. The ground truth was established by comparing the device's readings to the manual method of measuring blood pressure using a mercury manometer and a stethoscope. This is a direct comparison rather than an adjudication of multiple expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. The document describes a bench test comparing the device to a manual method, not an MRMC study assessing human reader performance with and without AI assistance.
6. Standalone Performance Study
- Standalone Study Done? Yes. The study focused on the accuracy of the BPBIO210/220/210T/220T device itself in comparison to the manual method using a mercury manometer and a stethoscope. This evaluates the algorithm's performance (or in this case, the device's accuracy as a measurement tool for manually read Korotkoff sounds) independent of human interpretation biases beyond the initial listening.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by direct comparison to a manual method of measuring blood pressure using a mercury manometer and a stethoscope, which is considered the gold standard for this type of device.
8. Sample Size for the Training Set
- Sample Size: Not applicable. The device is a manual blood pressure monitor that uses the Korotkoff sound method. It is not an AI/algorithm-driven device in the sense of requiring a "training set" for machine learning. The "bench testing" described is for validation and verification, not for training a model.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no "training set" for a machine learning model. The device's operation relies on a physical process and the user's ability to interpret Korotkoff sounds.
§ 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).