(177 days)
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 36cm or 22cm to 42cm or 32cm to 48cm.
The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 13.5cm to 21.5cm.
The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm/wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
Meanwhile, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.
The provided document outlines the substantial equivalence of the "Arm-type Fully Automatic Digital Blood Pressure Monitor" and "Wrist-type Fully Automatic Digital Blood Pressure Monitor" to previously cleared predicate devices. The primary focus for proving substantial equivalence concerning performance criteria relies on adherence to the ISO 81060-2:2018+AMD2020 standard for non-invasive sphygmomanometers.
Here's an breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the ISO 81060-2:2018+AMD2020 standard, which is a recognized standard for clinical validation of non-invasive sphygmomanometers. The reported performance is the conclusion that the devices meet these requirements.
| Acceptance Criteria (from ISO 81060-2:2018+AMD2020) | Reported Device Performance |
|---|---|
| Accuracy Standard Deviations (SD): | |
| Systolic Blood Pressure: SD ≤ 8 mmHg | Met the criteria |
| Diastolic Blood Pressure: SD ≤ 8 mmHg | Met the criteria |
| Mean Difference (MD): | |
| All measurements: MD ≤ 5 mmHg | Met the criteria |
| Individual measurements: Differences ≤ 5 mmHg for Majority of Measurements | Met the criteria |
| Pulse Rate Accuracy: | Pulse: ± 5% |
| Pulse Rate: Within specified limits |
Note: The document broadly states that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." Specific numerical mean differences and standard deviations for systolic and diastolic pressures are not explicitly provided, but the statement confirms compliance with the standard's thresholds.
2. Sample Sizes Used for the Test Set and Data Provenance
- Arm-type (Cuff 22cm~42cm): 88 patients (47 females and 41 males). This data was from a clinical investigation report from another submission. The provenance is not explicitly stated as retrospective or prospective, but the context of "clinical study" typically implies prospective data collection for validation. The country of origin is also not specified.
- Arm-type (Cuff 32cm-48cm): 85 patients (36 females and 49 males). This data was collected using Model DBP-6279B as a representative for testing. The provenance is not explicitly stated as retrospective or prospective, but the context of "clinical study" typically implies prospective data collection for validation. The country of origin is also not specified.
- Arm-type (Cuff 22cm~36cm) and all Wrist-type models: For these, the applicant states they "cite the clinical investigation report of K212115," implying the sample sizes and provenance from that prior submission. The specific sample sizes for K212115 are not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for blood pressure measurements in the clinical validation studies was established through the "same arm sequential method" using a manual Mercury Sphygmomanometer as a reference device. This method implies that trained healthcare professionals, likely physicians or nurses, would have been responsible for obtaining the reference measurements. However, the exact number of experts/operators and their specific qualifications are not explicitly stated in this document. The ISO 81060-2 standard would require trained observers, but the document does not elaborate on this.
4. Adjudication Method for the Test Set
The "same arm sequential method" involves taking measurements simultaneously or in quick succession using both the device under test and the reference device on the same arm. This method inherently minimizes the need for an adjudication method in the traditional sense, as the comparison is direct. The standard outlines specific procedures for discrepancies and ensuring observer blinding where appropriate, but no explicit "adjudication" of disagreements between device and reference (beyond the statistical analysis) is mentioned.
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
This is not applicable. The device is a fully automatic digital blood pressure monitor, not an AI-assisted diagnostic device involving human readers or interpretation of medical images. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be performed for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The clinical validation studies described (using the "same arm sequential method" against a reference sphygmomanometer) directly assess the accuracy of the device's algorithm in measuring blood pressure and pulse rate without human-in-the-loop diagnostic interpretation. The device's primary function is automatic measurement, and the clinical studies validate this automatic function.
7. The Type of Ground Truth Used
The ground truth used was expert reference measurements obtained using a manual Mercury Sphygmomanometer. This is considered a gold standard (or a widely accepted clinical standard) for blood pressure measurement in clinical validation studies as per ISO 81060-2.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate training set or its sample size. Medical devices like blood pressure monitors are typically developed using internal data and engineering principles, with clinical validation as the final step to demonstrate accuracy against a recognized standard. It's common for the development and optimization of the oscillometric algorithm to occur internally without public disclosure of a specific "training set" size in regulatory submissions for these types of devices. The filing focuses on the validation of the final product.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned, the method for establishing its ground truth is also not provided. The focus of the submission is on the clinical validation of the finished 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).