(250 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
The Electronic Sphygmomanometer uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START/STOP" button, the cuff is inflated automatically by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. The device will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.
Below is the information regarding the acceptance criteria and the study that proves the device meets those criteria, as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines an "Accuracy" acceptance criterion for the device, which is consistent with the predicate device. The clinical study results are stated to have met this criterion.
| Acceptance Criterion | Reported Device Performance (Targeted device: LT-P30) |
|---|---|
| Accuracy (Blood Pressure) | Pressure: ±3mmHg or ±2% of measured value, whichever is greater |
| Met criteria 1 and 2 of ISO 81060-2 | |
| Accuracy (Pulse Rate) | Pulse Rate: ±5% |
| Met criteria 1 and 2 of ISO 81060-2 |
2. Sample size used for the test set and the data provenance:
- Sample Size: 120 subjects
- Data Provenance: Not explicitly stated, but the study was conducted to meet ISO 81060-2 standards, which are international. It's implied to be prospective as it describes a clinical validation study.
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. For blood pressure monitors validated according to ISO 81060-2, the "ground truth" (reference blood pressure) is typically established by trained observers (usually clinicians) using a mercury sphygmomanometer or an equivalent reference device, but the specific number and qualifications of these observers are not detailed here.
4. Adjudication method for the test set:
The adjudication method is not explicitly described. However, the ISO 81060-2 standard, which the study adhered to, typically involves simultaneous auscultatory measurements by two trained observers, often with a third observer for adjudication in cases of discrepancies.
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. This device is an Electronic Sphygmomanometer for automated blood pressure measurement, not an AI-assisted diagnostic tool requiring human reader interpretation. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone clinical validation study was performed for the device. The study evaluated the accuracy of the automated non-invasive sphygmomanometer (Electronic Sphygmomanometer Model: LT-P30) against a reference method as per ISO 81060-2.
7. The type of ground truth used:
The ground truth for the clinical validation was established by a reference method, typically auscultation by trained observers, as specified by the ISO 81060-2 standard for clinical validation of automated non-invasive sphygmomanometers.
8. The sample size for the training set:
Not applicable. This document describes the validation of a medical device (Electronic Sphygmomanometer) which is likely based on an algorithmic approach but not an "AI" device in the sense of requiring a "training set" in machine learning. Its accuracy and performance are based on its physical design and established oscillometric principles.
9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a "training set" in the context of machine learning for this device. The device's operational principles are established, and its accuracy is clinically validated.
§ 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).