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BP5S Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

BP5S Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LED. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

The provided text describes the 510(k) submission for the BP5S Wireless Blood Pressure Monitor. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any specific clinical performance studies. It mentions that non-clinical tests were performed according to specified IEC standards. For the performance characteristics related to blood pressure accuracy (IEC 80601-2-30), these standards typically require clinical validation with a certain number of subjects, but the details of this specific study are not provided in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided. The summary focuses on standard compliance and technology comparisons, not details of clinical study design regarding ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is a blood pressure monitor, not an imaging or diagnostic AI system that would typically involve human reader interpretation.

6. Standalone (Algorithm Only) Performance Study

The information provided describes the device's performance in terms of adherence to international standards for blood pressure monitors. The device itself performs the measurement and calculation of blood pressure. Therefore, the "standalone" performance is inherent in its design and its ability to meet the specified performance standards. The Non-clinical Tests and Performance Summary paragraphs implicitly refer to the standalone performance of the device in measuring blood pressure and pulse rate according to the specified standards.

7. Type of Ground Truth Used

For the specific performance related to blood pressure measurement, the ground truth would be established by reference measurements taken simultaneously with a validated method (e.g., by trained observers using a mercury sphygmomanometer or an equivalent reference device) as prescribed by the IEC 80601-2-30 standard. However, the document does not explicitly detail the ground truth method used in the validation study.

8. Sample Size for the Training Set

This information is not applicable and not provided. The BP5S is a traditional blood pressure monitor based on oscillometric technology, not an AI/machine learning device that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reason as above.

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