(63 days)
HL858DI automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
HL858DI detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator with the readings on the screen for the user tracking their blood pressure level.
HL858DI automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
The device will display a symbol ( ** or ma), to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
The provided document describes the Health & Life Co., Ltd. Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DI, and its clinical validation according to ISO 81060-2.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for non-invasive sphygmomanometers are typically defined by standards like ISO 81060-2 for blood pressure measurement accuracy. The document states that the device is compliant with ISO 81060-2: Second Edition 2013-05-01. This standard sets specific requirements for mean difference and standard deviation between the device's readings and a reference measurement.
Although the exact numerical acceptance criteria for mean difference and standard deviation from ISO 81060-2 are not explicitly listed in the document, it states that:
| Acceptance Criteria (Based on ISO 81060-2) | Reported Device Performance |
|---|---|
| Required limits for mean difference | Fulfilled |
| Required limits for standard deviation | Fulfilled |
Note: The specific numerical thresholds for "required limits" would be found within the ISO 81060-2 standard itself, which is referenced but not fully reproduced here.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 105 subjects.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical investigation," implying prospective data collection during the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth measurements during the clinical investigation. However, for a study compliant with ISO 81060-2, it is implicit that trained observers (often physicians or qualified medical personnel) follow a standardized protocol (e.g., using a mercury sphygmomanometer or validated auscultatory method) to provide the reference blood pressure readings against which the device's measurements are compared.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method beyond stating that the relevant activities were performed by "designate individual(s)." In the context of ISO 81060-2, the ground truth is typically established by multiple trained observers taking readings independently, and then their measurements are averaged or assessed for agreement, but the specific details are not provided here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a standalone clinical validation of the device's accuracy against a reference standard, not a comparison of human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study was done. The clinical investigation directly assessed the performance of the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DI, which operates as an automated device (algorithm only for measurement capture), against a human-obtained reference standard.
7. The Type of Ground Truth Used
The ground truth used was reference blood pressure measurements obtained from qualified personnel during the clinical investigation, following established protocols for accuracy in blood pressure measurement (as implied by compliance with ISO 81060-2). This is typically auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference method.
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. The clinical investigation mentioned (with 105 subjects) appears to be the test set for validating the device's performance according to ISO 81060-2. As this is a blood pressure monitor, the "training" of its internal algorithm would likely occur during its development phase using various datasets, but these details are not part of this submission document.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, the method for establishing its ground truth is also not provided in this document.
§ 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).