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The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is a hand held battery operated wrist type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.

The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
SAW-102 uses an inflated cuff which is wrapped around the upper wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. 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 one minute. After one minute without operation, SAW-102 turns off automatically.
SAW-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is a hand held battery operated wrist type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.

The provided text is a 510(k) summary for the SensaCare SAW-102 Wrist Digital Blood Pressure Monitor. It outlines the device description, intended use, predicate device, and technological characteristics. However, it does not contain specific details about acceptance criteria, detailed study results, sample sizes for test and training sets, ground truth establishment, or expert qualifications as requested in your prompt.

The document states:

• "Extensive functional and performance testing, and biocompatibility testing were conducted to assess the safety and effectiveness of the SensaCare SAW-102 Wrist Digital Blood Pressure Monitor. All results are satisfactory."

This is a general statement and does not provide the specific data points you're asking for.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided input. The document is primarily a regulatory filing (510(k)) that declares substantial equivalence to a predicate device, rather than a detailed report of the device's technical performance study.

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