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The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, measures systolic and diastolic blood pressure and pulse rate of an adult individual. The method used to define blood pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The electrical signals are analyzed and used to define the systolic and diastolic measurements and determine the pulse rate. An irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

Here's a breakdown of the acceptance criteria and the study information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to meeting established standards, rather than defining specific numerical acceptance criteria within the 510(k) summary itself. The reported device performance is that it met these standards.

(Note: ANSI/AAMI SP10 is the standard for non-invasive sphygmomanometers, covering accuracy requirements for blood pressure devices. The IEC/EN 60601 series covers medical electrical equipment safety. The specific numerical accuracy criteria are contained within the ANSI/AAMI SP10 standard, but are not explicitly listed in this 510(k) summary.)

Missing Information: The document does not explicitly state the numerical acceptance criteria from ANSI/AAMI SP10, nor does it provide the exact performance metrics (e.g., mean difference and standard deviation) for blood pressure measurements and pulse rate as specified in that standard. It only states that the device "meets all applicable requirements."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Bench testing was conducted" and refers to meeting standards, but does not provide details on the number of subjects or measurements included in these tests for accuracy evaluation.
• Data Provenance: Not explicitly stated. It's likely prospective data collected during the bench testing, but the country of origin is not mentioned.

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

This information is not provided in the document. For blood pressure monitors, ground truth is typically established against a reference method (e.g., auscultatory method with a trained observer using a mercury sphygmomanometer) and not usually by "experts" in the sense of radiologists.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the performance testing of an automated blood pressure monitor. Accuracy is assessed by comparing the device's readings against a validated reference measurement, not through expert adjudication of images or diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on reader performance. This device is an automated blood pressure monitor.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in essence, a standalone performance study was done. The "Bench testing" against ANSI/AAMI SP10 (which includes clinical validation protocols) assesses the algorithm's performance in automatically measuring blood pressure and pulse rate without human intervention beyond device operation. The device is designed to operate autonomously to produce readings.

7. The Type of Ground Truth Used

The ground truth used for the performance testing (specifically, for conforming to ANSI/AAMI SP10) would be a validated reference measurement method, such as the auscultatory method performed by trained observers using a reference sphygmomanometer (e.g., mercurial or laboratory-grade aneroid manometer). This is implied by the reference to the ANSI/AAMI SP10 standard.

8. Sample Size for the Training Set

This information is not provided. Blood pressure monitors using the oscillometric method rely on algorithms that are developed and validated over time, likely with extensive datasets from various populations. The specific training set for this particular product is not detailed in the summary.

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

This information is not provided. For oscillometric algorithms, the development process generally involves comparing numerous oscillometric waveforms to simultaneous reference blood pressure measurements (established via auscultation or intra-arterial monitoring) across a diverse patient population to train and refine the algorithm's ability to accurately derive systolic and diastolic pressures from the oscillations.

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