(106 days)
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:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10 compliance | Meets all applicable requirements |
| IEC/EN 60601-1 compliance | Meets all applicable requirements |
| IEC/EN 60601-1-2 compliance | Meets all applicable requirements |
| IEC/EN 60601-1-4 compliance | Meets all applicable requirements |
| Biocompatibility (ISO 10993): In vitro cytotoxicity | No cytotoxicity |
| Biocompatibility (ISO 10993): Sensitivity | No sensitivity |
| Biocompatibility (ISO 10993): Irritation | No irritation |
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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).