(246 days)
Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.
The Arm-Type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
For BP-46 and BP-1304, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification. which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, and pulse rate information. They will display an irregular heartbeat symbol "《♥》" if an irregular heartbeat was detected during the measurement process. BP-46 can display average results in three ways.
The device is designed and manufactured according to AAMI / ANSI / IEC 80601-2-30:2009. medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
The provided text describes a 510(k) submission for a blood pressure monitor, focusing on demonstrating substantial equivalence to a predicate device. However, it does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) study regarding acceptance criteria, performance metrics, ground truth establishment, or multi-reader studies.
Therefore, I cannot extract the specific information requested in your prompt as it pertains to a different type of medical device clearance and study methodology. The document is for a non-AI, hardware-based blood pressure monitor and focuses on compliance with general safety and performance standards for such devices, rather than AI model performance or clinical utility compared to human readers.
Specifically, the following points cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: The document states "The test result all meet or exceed the requirement of the standards" for non-clinical tests and "Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01" for clinical tests, but it does not provide specific numerical acceptance criteria or reported performance values.
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable as there is no AI component or human reader element.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a device for direct measurement, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a blood pressure monitor, "ground truth" typically refers to reference measurements (e.g., from an oscillometric or auscultatory method) rather than expert consensus on images or pathology. The document mentions compliance with ISO 81060-2, which dictates clinical validation methods for non-invasive sphygmomanometers, implying a comparison to a referencestandard, but the specific details are not provided.
- The sample size for the training set: Not applicable as there is no AI or machine learning model for training.
- How the ground truth for the training set was established: Not applicable.
§ 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).