(85 days)
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch) or 22 to 45cm (8.6 to 17.7 inch).
Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2245-021, arm circumference range is 22-45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.
The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 450 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices embed a Cellular Wireless network connections module that allows it to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
The provided text describes the acceptance criteria and study proving the device meets those criteria for a Blood Pressure Monitor.
Here's the breakdown of the information requested:
Acceptance Criteria and Reported Device Performance
The clinical performance acceptance criteria for this blood pressure monitor are based on the ISO 81060-2:2018/Amd.1:2020 standard, specifically Criterion 1 and Criterion 2. These criteria define the acceptable mean difference and standard deviation between the device readings and reference blood pressure measurements.
Table of Acceptance Criteria and Reported Device Performance
| Criterion | Measurement | Acceptance Criteria (Mean Difference ± Standard Deviation) | Reported Performance (Mean Difference ± Standard Deviation) | Study(s) this applies to |
|---|---|---|---|---|
| Criterion 1 | SBP | ≤ ±5 mmHg | ||
| DBP | ≤ ±5 mmHg | |||
| Criterion 2 | SBP & DBP | Standard deviation of differences ≤ 8 mmHg | ||
| The percentage of differences within 5 mmHg: at least 65% | ||||
| The percentage of differences within 10 mmHg: at least 85% | ||||
| The percentage of differences within 15 mmHg: at least 95% |
Detailed Reported Performance from Clinical Studies:
| Clinical Study | Cuff Model | Subjects | SBP Mean Difference ± SD (Criterion 1) | DBP Mean Difference ± SD (Criterion 1) | SBP Mean Difference ± SD (Criterion 2) | DBP Mean Difference ± SD (Criterion 2) | Fulfilled Criteria (ISO 81060-2:2018/Amd.1:2020) |
|---|---|---|---|---|---|---|---|
| First Clinical Study (AC1636-01) | AC1636-01 | 36 children (aged 9.8±5.1) and 52 adults (aged 52.6±28.2) | 0.25 ± 3.02 mmHg | 0.96 ± 2.54 mmHg | 0.25 ± 2.55 mmHg | 0.96 ± 2.32 mmHg | Both Criterion 1 and 2 and |
| Second Clinical Study (AC2245-021) | AC2245-021 | 86 subjects (aged 49.1±18.5) | -1.1 ± 3.51 mmHg | -0.2 ± 3.70 mmHg | -1.1 ± 2.22 mmHg | -0.2 ± 2.82 mmHg | Both Criterion 1 and 2 |
| Third Clinical Study (diabetes) | AC2245-021 | 90 diabetic patients | -1.11 ± 3.50 mmHg | -1.24 ± 3.21 mmHg | -1.11 ± 3.19 mmHg | -1.24 ± 3.01 mmHg | Both Criterion 1 and 2 |
| Fourth Clinical Study (pregnant) | AC2245-021 | 91 pregnant women (12-40 weeks pregnant: 38.5% normotensive, 30.8% hypertensive, 30.8% preeclampsia) | -2.74 ± 5.61 mmHg | 0.13 ± 4.48 mmHg | -2.74 ± 5.11 mmHg | 0.13 ± 4.02 mmHg | Criterion 2 (Only Criterion 2 for pregnant as per standard) |
| The text indicates that the device fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020 for the first three studies and fulfilled validation criteria 2 for the pregnant patient study. This implies the reported mean differences and standard deviations were within the limits specified by the standard. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Total Clinical Study Subjects: 138 general adult subjects (aged 3-12 years for children and general adults), 90 diabetic patients, and 91 pregnant women.
- First Clinical Study (AC1636-01): 261 datasets collected from 88 subjects (36 children and 52 adults)
- Second Clinical Study (AC2245-021): 258 datasets collected from 86 subjects (general adults)
- Third Clinical Study (diabetes): 268 valid BP dataset pairs collected from 90 diabetic patients
- Fourth Clinical Study (pregnant): 270 valid datasets collected from 91 pregnant subjects
- Data Provenance: Not explicitly stated, but typically clinical studies for regulatory submissions are prospective. The location (country of origin) is not mentioned in the provided text, but the manufacturer is based in China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the ground truth (reference blood pressure measurements) was established by standard clinical methods using a reference device or trained observers as required by ISO 81060-2:2018/Amd.1:2020. However, the exact number and qualifications of experts (e.g., radiologists, cardiologists) that would typically establish such ground truth in the context of blood pressure measurement (e.g., supervising the auscultatory method or reading a reference device) are not specified in the provided text. The standard usually requires trained observers for the reference measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not explicitly state an adjudication method. For blood pressure measurement validation studies, this typically involves simultaneously taking measurements with the device under test and a calibrated reference device (or multiple trained observers using the auscultatory method). The ISO 81060-2 standard outlines the methodology for obtaining reference measurements, often involving multiple mercury sphygmomanometers and trained observers. No further details on adjudication are provided.
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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. This is a study to validate a blood pressure monitor, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes. The tests described are for the standalone performance of the blood pressure monitor, which uses an oscillometric algorithm to measure blood pressure without active human interpretation during the measurement process itself, beyond initiation and cuff placement. The performance data presented are for the device (algorithm) measuring blood pressure against a reference.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by reference blood pressure measurements obtained from clinical studies, presumably following the methodology detailed in ISO 81060-2:2018/Amd.1:2020. This standard typically relies on simultaneously recording blood pressure using a validated reference method (e.g., auscultatory method by trained observers using mercury sphygmomanometers, or other validated reference devices) and comparing it to the device under test.
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The sample size for the training set:
- The document describes clinical validation studies (test sets) for the device. It does not provide information on the sample size used for the training set for the device's underlying algorithm development. Blood pressure monitors often use long-established algorithms, but if machine learning was used, the training set details are not provided.
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How the ground truth for the training set was established:
- Since details of a specific training set are not provided, information on how its ground truth was established is also not available in the provided text.
§ 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).