(191 days)
This device is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.
The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic noninvasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric technique. The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The subject device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.
The proposed blood pressure monitor includes two models, which are W05, W1101L. All models contain the same software, measurement principle and NIBP algorithm. The main differences are product appearance, specification of pump and specification of the battery. W05 is alkaline battery driven device and W1101L is lithium battery driven device.
Here's a breakdown of the acceptance criteria and the study details for the Shenzhen Jamr Technology Co., Ltd. Wrist Type Blood Pressure Monitor (W05, W1101L):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard ISO 81060-2:2018) | Reported Device Performance (Clinical Test Summary) |
|---|---|
| Mean error for blood pressure measurements | Fulfilled required limits |
| Standard deviation for blood pressure measurements | Fulfilled required limits |
| Pressure Accuracy: ± 3 mmHg | Pressure Accuracy: ± 3 mmHg (Same) |
| Pulse Rate Accuracy: ± 5 % BPM | Pulse Rate Accuracy: ± 5 % BPM (Same) |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: 95 patients.
- Data Provenance: The document does not explicitly state the country of origin. The study was a clinical investigation performed to verify accuracy according to ISO 81060-2:2018, which is a standard for clinical investigation of intermittent automated measurement type for non-invasive sphygmomanometers. It describes patients with "adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site." It is a prospective clinical test, as new measurements were taken for the study.
3. Number of Experts and Qualifications for Ground Truth:
- The document implies that the ground truth was established by the standard auscultation method, which is performed by trained medical professionals. However, the exact number of experts and their specific qualifications (e.g., number of years of experience) used to establish the ground truth for this particular test set are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set:
- The document states, "Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2 Third edition 2018-11." This indicates a direct comparison approach, but no specific adjudication method (like 2+1 or 3+1 for resolving discrepancies) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by humans.
6. Standalone Performance Study:
- Yes, a standalone performance study was done. The clinical test summarized in the document directly evaluates the device's accuracy in measuring blood pressure and pulse rate against a reference standard (auscultation) without human-in-the-loop assistance. The device's measurement principle is described as "oscillometric technique," which is an automated process.
7. Type of Ground Truth Used:
- Expert consensus (indirectly through a standard method): The ground truth was established using the standard auscultation method. This method relies on the auditory interpretation of Korotkoff sounds by trained human observers, which can be considered an expert-derived ground truth.
8. Sample Size for the Training Set:
- The document does not provide information about a separate training set or its sample size. Blood pressure monitors typically rely on established algorithms for oscillometric measurements, rather than machine learning models that require a distinct training set in the same way an AI diagnostic tool would.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not explicitly mentioned or implied for this type of device (a traditional blood pressure monitor using an oscillometric algorithm), the document does not explain how ground truth for a training set was established.
§ 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).