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The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-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 Wrist Automatic Blood Pressure Monitor, Model ABA-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. The irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701, underwent performance testing to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the exact sample size or data provenance details (e.g., country of origin, retrospective or prospective) for the performance testing. It generally states that "Bench testing was conducted to demonstrate that the device meets its Requirements Specification." For biocompatibility, it states "Testing was performed for in vitro cytotoxicity, sensitivity, and irritation according to ISO 10993 requirements."

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

This information is not provided in the document. The performance testing appears to be based on adherence to recognized standards (ANSI/AAMI SP10, IEC/EN 60601 series, ISO 10993) rather than an expert-driven ground truth establishment for a specific clinical dataset.

4. Adjudication method for the test set:

Not applicable, as the evaluation was based on compliance with established technical and biological standards, not on subjective interpretations requiring adjudication.

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 device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

Yes, the performance testing described for the Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701, is a standalone evaluation of the device's technical specifications and biological safety without human-in-the-loop performance in a comparative study context. The device utilizes an "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." This is an algorithm-driven process.

7. The type of ground truth used:

The ground truth used for this device is based on established, well-known technical and biological standards:

• ANSI/AAMI SP10: This standard specifies requirements for non-invasive sphygmomanometers. Compliance with this standard indicates the device's accuracy in measuring blood pressure against accepted methods and criteria.
• IEC/EN 60601-1, -1-2, -1-4: These are general standards for the safety and essential performance of medical electrical equipment, including electromagnetic compatibility and programmable electrical medical systems. Compliance demonstrates adherence to fundamental safety and performance requirements.
• ISO 10993: This standard series deals with the biological evaluation of medical devices. Biocompatibility testing (cytotoxicity, sensitivity, irritation) ensures the materials in contact with the patient (e.g., the cuff) are safe and do not elicit adverse biological reactions.

8. The sample size for the training set:

Not applicable. This device is a measurement device that uses a pre-defined algorithm (oscillometric method) rather than a machine learning model that requires a training set. The "software algorithm" for determining blood pressure is cited as "well known" and not described as being developed through a data-driven training process.

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

Not applicable, as there is no mention of a training set for a machine learning algorithm. The device relies on the established principles of the oscillometric method.

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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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