(195 days)
Measure blood pressure(systolic and diastolic) and pulse rate.
Upper Arm Electronic Blood Pressure Monitor, Model U86E and TelliBP01 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a wellknown technique in the market called the "oscillometric method".
The main components of the Upper Arm Electronic Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately 22 cm to 42 cm, includes the inflatable bladder and fabric. The device consists of the main unit and cuff.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
Model U86E and TelliBP01 in this submission follow the similar software, same measurement principle and similar specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device.
The model U86E embed an Bluetooth Wireless network connections module that allows it to send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments. The TelliBP01 embed a SIM card, which can send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments through 4G network. The wireless functions of U86E and TelliBP01 only have data transmission function, without any control feature.
Here's an analysis of the acceptance criteria and study details for the Upper Arm Electronic Blood Pressure Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The clinical study for the device refers to "Criterion 1" and "Criterion 2" of ISO 81060-2:2018/A1:2020. This indicates that these are the acceptance criteria. The ISO 81060-2 standard defines accuracy requirements for automated sphygmomanometers. Based on the document, the requirements for clinical validation are as follows:
| Acceptance Criteria (from ISO 81060-2:2018/A1:2020) | Reported Device Performance (Subject Device) | Pass/Fail |
|---|---|---|
| Criterion 1: | Pass | |
| Mean difference (device - reference) ≤ 5 mmHg | Systolic BP: 0.17 mmHg | Pass |
| Diastolic BP: 0.29 mmHg | Pass | |
| Standard deviation ≤ 8 mmHg | Systolic BP: 7.52 mmHg | Pass |
| Diastolic BP: 5.35 mmHg | Pass | |
| Criterion 2: | Pass | |
| Mean difference (device - reference) | Systolic BP: 0.33 mmHg | Pass |
| Standard deviation | Systolic BP: 6.84 mmHg | Pass |
| Diastolic BP: 0.37 mmHg | Pass | |
| Diastolic BP: 4.77 mmHg | Pass | |
| Note: Criterion 2 often refers to a percentage of differences within certain thresholds (e.g., within 5, 10, 15 mmHg), but the document only provides mean difference and standard deviation values. The wording suggests these values are for Criterion 2, similar to Criterion 1, and implicitly they meet the ISO standard's requirements for passing Criterion 2. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 93 qualified participants.
- Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical accuracy testing" and the language used in the document is English, but it's for a Chinese manufacturer. The study is prospective, as it's a "clinical study" performed for the purpose of validating the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The document mentions "A Mercury Sphygmomanometer was used as a reference device" which implies human observers for the reference measurements.
- Qualifications of Experts: Not explicitly stated. For a clinical validation of blood pressure devices using a mercury sphygmomanometer, it is generally understood that trained medical professionals or observers are required to take the reference readings and usually two observers are used for comparison, but the document does not specify their roles or qualifications.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. For clinical validation of blood pressure monitors, if multiple observers are used for the reference method (e.g., auscultatory method with mercury sphygmomanometer), their readings would typically be averaged or adjudicated if they differ significantly. However, the document only mentions "A Mercury Sphygmomanometer was used as a reference device," which doesn't detail the number of observers or any adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The clinical testing performed according to ISO 81060-2:2018/A1:2020 evaluates the accuracy of the automated device (algorithm only) against a reference standard (mercury sphygmomanometer). The device is designed to provide readings automatically without human-in-the-loop interpretation once the measurement is initiated.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus via a reference device (Mercury Sphygmomanometer). The document states: "A Mercury Sphygmomanometer was used as a reference device." This is standard clinical practice for validating automated blood pressure monitors.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not provided in the document. The document describes clinical validation testing, which is separate from the training of the device's algorithms. The "oscillometric method" is a well-known technique, implying the core algorithm is established, but details of its training data (if any specific to this model's algorithm rather than general knowledge) are not included.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not provided. As stated above, the document focuses on the clinical validation of the device, not the development or training of its internal algorithms. The "oscillometric method" is a fundamental principle, and any specific training data and its ground truth establishment for this device's implementation of that method are not discussed.
§ 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).