(128 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure. The algorithm used to determine pulse rate, systolic and diastolic pressure is a minor modification of the predicate algorithm. The device has a memory function that automatically stores up to 100 of the latest measurements. It can also display an average of the last three values. The device also detects the appearance of irregular heartbeats during measurement.
The Omron BP652N (HEM-6300-Z) blood pressure monitor underwent non-clinical testing to ensure its accuracy and compliance with relevant standards. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate K042505) | Reported Device Performance (BP652N) |
|---|---|---|
| Accuracy of Pressure | +/- 3 mmHg | +/- 3 mmHg (or 2% of reading) |
| Accuracy of Pulse Rate | +/- 5% | +/- 5% |
2. Sample Size and Data Provenance for Test Set
The provided document does not explicitly state the sample size used for the clinical accuracy test set, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions that testing was done "to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2." This standard typically outlines requirements for non-invasive sphygmomanometers, including patient selection criteria for clinical validation.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. For clinical accuracy studies of blood pressure monitors, ground truth is typically established by trained observers (often medical professionals) using a reference sphygmomanometer following a standardized protocol.
4. Adjudication Method for the Test Set
The document does not detail any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission focuses on the standalone performance of the device and its substantial equivalence to a predicate device.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done to assess the clinical accuracy of the device. This is implied by the statement "Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2." This standard specifies the clinical investigation of automated sphygmomanometers, which involves comparing the device's readings against a reference measurement. The results of this testing were that the device met the requirements for pressure accuracy (+/- 3 mmHg) and pulse rate accuracy (+/- 5%).
7. Type of Ground Truth Used
Based on the nature of blood pressure monitor accuracy testing and the reference to ANSI/AAMI/ISO 81060-2, the ground truth would have been established by expert reference measurements (e.g., using a mercury sphygmomanometer or validated electronic reference device) obtained by trained observers.
8. Sample Size for the Training Set
The document does not specify a separate training set. For blood pressure monitors, the "algorithm" is often based on established oscillometric principles, and its performance is validated rather than "trained" in the machine learning sense. The device's algorithm is described as a "minor modification of the predicate algorithm," suggesting an evolution rather than a de novo machine learning model requiring a distinct training set.
9. How Ground Truth for the Training Set was Established
As no explicit training set is mentioned in the context of machine learning, this information is not applicable. The device's algorithm would have been developed and refined based on engineering principles and data from prior validation efforts of similar oscillometric devices.
§ 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).