(22 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 -42 cm) via an "arm in" cuff.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guidelines of 135/85 mm Hg.
The Omron 1500Pro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
It is intended as an OTC device for home use.
The Omron 1500Pro blood pressure monitor is a slightly modified version of the HEM-780N3 (K061822) blood pressure monitor.
The 1500Pro blood pressures monitor is intended to monitor:
- . Blood pressure
- . Pulse rate
The difference between the proposed 1500 Pro and the HEM-780N3 has to do with the cuff design. All other features, functions and technologies are identical to the predicate.
The provided document is a 510(k) Premarket Notification for the Omron 1500 Pro blood pressure monitor. It serves as a declaration of substantial equivalence to a predicate device (Omron HEM 780N3, K061822) rather than a study demonstrating the device meets specific acceptance criteria through a clinical trial. Therefore, many of the requested elements for a study proving acceptance criteria will not be found as this is a regulatory submission for substantial equivalence.
Based on the provided text, here's an attempt to answer the questions:
1. Table of acceptance criteria and the reported device performance
The document defines "Accuracy of pressure indicator" and "Accuracy of pulse rate" as specifications, which function as de facto acceptance criteria for the device's accuracy.
| Acceptance Criteria | Reported Device Performance (Omron 1500 Pro) |
|---|---|
| Accuracy of pressure indicator | Within ±3 mmHg or 2 % of reading |
| Accuracy of pulse rate | Within ±5 % of reading |
| Measurement method | Cuff oscillometric method |
| Measurement range (Pressure) | 0 to 294 mmHg |
| Measurement range (Pulse Rate) | 40 to 180 beats/min. |
| Irregular heart beat indication | Displays an irregular heart beat symbol when 2 irregular heart beats were detected during a measurement. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not report on a specific test set, its sample size, or data provenance for evaluating the Omron 1500 Pro's performance. The submission relies on demonstrating substantial equivalence to a predicate device (Omron HEM 780N3), implying that the predicate's performance data, which is not detailed here, is sufficient as the core technology and functionality are stated to be identical.
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 applicable. No independent test set with expert-established ground truth is described for the Omron 1500 Pro in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No independent test set is described.
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. The device is an automated blood pressure monitor; it does not involve human readers interpreting its output in a way that would necessitate an MRMC study related to AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document implicitly describes the standalone performance of the device by stating its measurement accuracy specifications. However, it does not present a standalone study with specific results but rather states the inherent performance characteristics of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy specifications ("Within ±3 mmHg or 2 % of reading" for pressure and "Within ±5 % of reading" for pulse rate), the ground truth would typically be established by a reference standard measurement (e.g., a mercury sphygmomanometer or an accepted standard for pulse rate measurement, often following a standard like ISO 81060-2). However, the document does not specify how these accuracy figures were derived for this particular device or its predicate. It merely states the published specifications which are common for such devices.
8. The sample size for the training set
Not applicable. This device is based on oscillometric technology, not a machine learning or AI algorithm that would typically require a "training set." The engineering and calibration of such devices are based on established physiological principles and extensive testing, not a machine learning training paradigm.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm for this device.
§ 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).