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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ ( BP4GAPO-2M ) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.

The Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch.

The device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch. Because the device does not contain an LCD or other display components, it is necessary for the device to connect with an iPhone, iPad, or iPod Touch containing supporting software to constitute a complete blood pressure measure system.

In addition, the device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.

Due to the nature of the provided text, which primarily describes a 510(k) premarket notification for a blood pressure monitor, it does not contain the detailed information typically found in a study report regarding acceptance criteria and performance of the device against those criteria.

Specifically, the document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests (reliability, EMC, safety) and stating that clinical testing for blood pressure accuracy is "not required" because the core measurement technology is identical to a previously cleared device.

Therefore, for the requested information, the following points can be extracted or noted as explicitly not provided in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The document states:

• "The subject modified device Model Cardio+ (BP4GAPO-2M) is, from the technical point of view, identical to the blood pressure monitor Model BP3AC1-1 PC. The differences between these two devices do not relate to blood pressure measurement technology. Therefore, the clinical accuracy in terms of blood pressure detection will not be affected. Based on this, repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required."

This indicates that no new clinical study was performed or presented in this 510(k) submission to directly prove the device's accuracy against specific acceptance criteria. Instead, the argument for substantial equivalence relies on the technical identity of the blood pressure measurement technology with a predicate device (Model BP3AC1-1 PC) that would have previously met such clinical accuracy standards (e.g., ANSI/AAMI SP10).

Additional Information (Extracted or Not Provided):

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

  • Not provided. No new clinical test set was described for blood pressure accuracy.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

  • Not provided. No new clinical test set was performed.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

  • Not provided. No new clinical test set was performed.

• 5. 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/Not provided. This device is a blood pressure monitor, not an AI-assisted diagnostic tool.

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

  • Not applicable/Not provided in the context of diagnostic performance. The device is an automated blood pressure monitor. Its "algorithm" (oscillometric method) is inherent to its function, and its performance is assumed to be equivalent to the predicate.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • Not explicitly stated for this submission. For blood pressure monitors, ground truth for clinical accuracy studies typically involves concurrent measurements by trained observers using a mercury sphygmomanometer (auscultatory method), often following standards like ANSI/AAMI SP10. The submission states that the predicate device would have met such standards.

• 8. The sample size for the training set:

  • Not applicable/Not provided. This is not an AI/machine learning device that involves a training set in the typical sense. The "training" would refer to the development and calibration of the oscillometric algorithm in the predicate device, for which details are not in this document.

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

  • Not applicable/Not provided. (See point 8).

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