(266 days)
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.
The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series, noninvasive, 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, the electric pump within the main unit slowly inflates the arm 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 measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement compares the longest and the shortest time intervals of detected pulse waves to the 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, this blood pressure monitor device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through 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 measurement results from the blood pressure monitor device, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user.
The provided text describes the 510(k) submission for the "Arm-type Fully Automatic Digital Blood Pressure Monitor, Model: BM 92". The main study used to demonstrate the device meets acceptance criteria is a clinical investigation following the ISO 81060-2:2018+AMD2020 standard, which focuses on the clinical investigation of intermittent automated measurement type non-invasive sphygmomanometers.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with the ISO 81060-2:2018+AMD2020 standard, which specifies accuracy requirements for blood pressure monitors. The document states:
"The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020."
While specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in the document, the adherence to this ISO standard implies meeting its criteria. The general accuracy specifications are given in the comparison table:
| Criteria Category | Acceptance Criteria (Implied by ISO 81060-2:2018+AMD2020) | Reported Device Performance (Summary) |
|---|---|---|
| Blood Pressure Accuracy | Within acceptable scope specified in ISO 81060-2:2018+AMD2020. | "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." |
| Static Pressure Accuracy | ± 3mmHg | ± 3mmHg |
| Pulse Accuracy | ± 5% | ± 5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "A total of 90 patients participated in the clinical study (2 were excluded because they were part of other clinical trials)." So, the effective sample size for the test set was 88 patients.
- Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is JOYTECH Healthcare Co., Ltd. located in Hangzhou, Zhejiang, China. Given this, it's highly probable the study was conducted in China. The study was a prospective clinical investigation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "A manual Mercury Sphygmomanometer was used as a reference device." This implies that the ground truth was established by human readers taking measurements using a mercury sphygmomanometer. However, the number of experts and their qualifications are not specified in the provided text. The ISO 81060-2 standard typically requires trained observers for reference measurements, but the details are omitted here.
4. Adjudication Method for the Test Set
The text mentions: "Same arm sequential method was adopted during the clinical testing. A manual Mercury Sphygmomanometer was used as a reference device." This suggests a comparative method, but it does not describe an adjudication method for discrepancies, which is usually relevant for subjective interpretations (e.g., image reading). For blood pressure measurements, the reference device readings are typically considered the objective ground truth; thus, a formal "adjudication" between multiple observers might not be explicitly detailed if the standard protocol for reference measurement was followed.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-assisted image interpretation devices to assess the impact of AI on human reader performance. The device described is an automated blood pressure monitor, not an AI interpretation system. Its function is to directly measure and display blood pressure, not to assist human readers in interpreting complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence, the device's accuracy was tested in a standalone manner. The device "determines" systolic and diastolic pressures using its internal algorithms (oscillometric method). The clinical study directly evaluated the accuracy of these measurements against a reference standard (manual mercury sphygmomanometer). The performance cited ("The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020") refers to the device's direct measurement capability.
7. The Type of Ground Truth Used
The ground truth used was comparative measurements against a manual Mercury Sphygmomanometer. The text states: "A manual Mercury Sphygmomanometer was used as a reference device." This is a standard method for establishing ground truth for automated blood pressure monitors.
8. The Sample Size for the Training Set
The document does not specify the sample size for a training set. This is common for traditional medical devices like blood pressure monitors, where "training" in the machine learning sense isn't explicitly detailed. The device likely relies on established oscillometric principles and algorithms developed over time, not a specific "training set" of patient data in the context of deep learning models.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for an AI model is mentioned or implied, the question of how its ground truth was established is not applicable in the context of the provided document. The device utilizes an "oscillometric method" and "software algorithms within the microprocessor," which are based on known physiological principles and traditional signal processing rather than data-driven machine learning training requiring a designated ground-truth dataset.
§ 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).