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Upper Arm Electronic Blood Pressure Monitor, Models FC-BP103, FC-BP106,FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131 are intended to measure the systolic and diastolic blood pressure 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 devices features include irreqular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.

The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than the measurement values. The unit also calculates an average reading based on the values of the latest 3 times measurement.

This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.

This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.

The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.

The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP121 and FC-BP130 applied).

There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.

No operation for 2 minute the device will shut down automatically.

The device includes model FC-BP103, FC-BP106,FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131,they are same except the appearance.

The provided text describes a 510(k) summary for an Upper Arm Electronic Blood Pressure Monitor (K242721) and states that it is substantially equivalent to a previously cleared predicate device (K220113). The submission focuses on demonstrating this substantial equivalence rather than presenting an exhaustive de novo study of the device's performance against specific acceptance criteria.

However, based on the Performance Comparison table provided, we can infer the acceptance criteria for key performance aspects based on what the device is reported to comply with. The study's conclusion is that the device meets these criteria because it is substantially equivalent to a predicate device that has already demonstrated compliance.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:
   The document explicitly states: "No additional non-clinical testing was considered necessary to support substantial equivalence" and "additional testing was not considered necessary to support the substantial equivalence." This implies that no new independent test set was used for the K242721 submission in terms of clinical accuracy or performance beyond functional verification of changes. The predicate device (K220113) would have undergone such testing. The current submission relies on the established performance of the predicate. Data provenance for the predicate device's original testing is not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no independent clinical study with expert ground truth establishment for the test set was reported for this specific submission (K242721). The submission relies on the predicate device's (K220113) previous validation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, for the same reason as above.

4. 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. The device is an Upper Arm Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, implicitly. The performance data for the blood pressure monitor is based on its standalone accuracy against reference measurements, as would be required by standards like IEC 80601-2-30. The "algorithm" for blood pressure measurement (oscillometric method) is core to the device's standalone performance. The document explicitly states "no changes made to the measurement algorithm, pressure sensor, cuff design, or calibration method" from the predicate device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For blood pressure monitors, the "ground truth" (or reference standard) in performance testing typically involves simultaneous measurements by trained observers using a validated auscultatory method (e.g., mercurial sphygmomanometer) as per standards like IEC 80601-2-30 or ISO 81060-2. This document references compliance with IEC 80601-2-30, implying that this standard's requirements for reference measurements were used in the predicate device's validation.

7. The sample size for the training set:
   Not applicable. This device is a medical measurement instrument, not an AI/ML device that requires a training set in the conventional sense. The "algorithm" refers to the oscillometric measurement method, which is a deterministic, established physiological principle, not a learned model.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this type of device.

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