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Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. with the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm).

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、FDBP-A8B、 FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、FDBP-A9B、FDBP-A9BL、FDBP-A9BT、 FDBP-A9BLT、FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT) includes utilize modular design method. It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, , wireless function module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filter signal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation/deflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.

The provided text describes the 510(k) submission for the Famidoc Technology Company Limited Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The information below is extracted from the provided text to fulfill the request.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance, particularly its clinical accuracy, is evaluated against the standards outlined in ISO 81060-2.

The document states: "The results showed the accuracy of the subject device is within acceptable scope specified in ISO 81060-2."

2. Sample size used for the test set and data provenance

• Sample Size: 85 patients (43 males)
• Data Provenance: The document does not explicitly state the country of origin but implies a clinical study was performed. It also does not specify if the study was retrospective or prospective, but clinical studies are generally prospective in nature.

3. Number of experts used to establish the ground truth for the test set and their qualifications

The document mentions "manual Mercury Sphygmomanometer was used as a reference sphygmomanometer." It does not specify the number of experts or their qualifications for establishing the ground truth, but implicitly, trained medical professionals would be operating the reference device.

4. Adjudication method for the test set

The document states, "Same arm sequential method was adopted during the clinical study." This refers to how measurements were taken, not an adjudication method for conflicting readings. No explicit adjudication method for the test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is an automated blood pressure monitor, not an AI-assisted diagnostic device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the device operates as a standalone automated blood pressure monitor. Its performance was tested directly against a reference standard in a clinical setting. The clinical study details describe the device's performance in measuring blood pressure and pulse rate without human-in-the-loop assistance in the measurement process itself, beyond initiation and observation.

7. The type of ground truth used

The ground truth for blood pressure and pulse rate measurements was established using a manual Mercury Sphygmomanometer. This is considered a clinical reference standard.

8. The sample size for the training set

The document does not provide a specific sample size for a training set. This is typical for medical devices that rely on established physical measurement principles (oscillometric method) and are validated against existing standards rather than necessarily "training" a machine learning algorithm in the same way an AI diagnostic tool would. If an algorithm within the device was developed using data, that information is not detailed here.

9. How the ground truth for the training set was established

As no explicit training set is mentioned in the context of machine learning, the ground truth establishment for such a set is not described. The device's underlying principles are based on oscillometric measurements, for which the fundamental accuracy is validated against clinical standards like mercury sphygmomanometers.

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