(88 days)
The product automatically measures human being's Systolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults with upper arm circumference ranging from 150 mm to 520 mm (Approx.6 ~ 21 inches) and for home use. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.
The AVITA Arm Type Blood Pressure Monitor (Model BPM82) consists of a main unit with an LCD display and four buttons, along with a cuff component. The device is designed for accurate and convenient monitoring of an individual's blood pressure and pulse rate through the application of oscillometric methodology. Specifically engineered for use on the upper arm, this over-the-counter device is tailored to adults with upper arm circumferences ranging from 150 mm to 520 mm (Approx. 6~ 21 inches) for in-home use.
Here's a breakdown of the acceptance criteria and study information for the AViTA Arm Type Blood Pressure Monitor (BPM82), based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 81060-2 / EN ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type) - Specific limits for mean difference and standard deviation | The results of the clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device for both systolic and diastolic blood pressures. The device "successfully passed validation" according to this standard. |
Note: The document only explicitly states the fulfillment of the required limits for mean difference and standard deviation, rather than providing the exact numerical values for these metrics.
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 90 adult subjects, resulting in 255 valid paired measurements.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical investigation," which is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Two observers.
- Qualifications: Not explicitly stated, but they used a "mercury sphygmomanometer," implying they were trained and qualified to expertly obtain blood pressure readings using this method, which serves as the ground truth.
4. Adjudication method for the test set:
- The document implies a direct comparison between the two observers using the mercury sphygmomanometer as the reference. It doesn't explicitly state an adjudication method like 2+1 or 3+1, but rather that "sequential measurements were taken... using a mercury sphygmomanometer (two observers) and the AVITA Blood Pressure Monitor." This suggests a direct comparison of the device's readings against these two expert readings.
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. This device is a standalone blood pressure monitor, not an AI-powered diagnostic imaging tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The clinical study tested the AViTA Arm Type Blood Pressure Monitor (BPM82) itself against the ground truth reference measurements. It's an automated device, so its performance is inherently "algorithm only" in its measurement function.
7. The type of ground truth used:
- Expert Consensus / Reference Standard Measurement: The ground truth was established by two observers using a traditional mercury sphygmomanometer, which is the accepted gold standard for blood pressure measurement in clinical validation protocols like ISO 81060-2.
8. The sample size for the training set:
- The document does not specify a sample size for a training set. This is a medical device validation study for a physical device, not an AI/machine learning model that typically has distinct training and test sets. The "clinical investigation" referred to here is for validating the final device.
9. How the ground truth for the training set was established:
- As no distinct training set is mentioned for this type of device, the method for establishing ground truth for a training set is not applicable in this context.
§ 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).