(47 days)
AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm~19.5cm.
AGE Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
Here’s a breakdown of the acceptance criteria and study information for the AGE Automatic Wrist Blood Pressure Monitor, models BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, and BW-613, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (from ISO 81060-2) | Reported Device Performance (Subject Device) |
|---|---|---|
| Accuracy (Pressure) | Not explicitly stated as acceptance criteria, but standard clinical validation requires meeting specific thresholds (e.g., mean difference ≤ ±5 mmHg, standard deviation ≤ 8 mmHg for paired measurements between the device and a reference measurement, across a patient population per ISO 81060-2). | ±3 mmHg (claimed accuracy) |
| Accuracy (Pulse) | Not explicitly stated as acceptance criteria. | ±5% (claimed accuracy) |
| Measuring Range (Pressure) | Standard requirements per ISO 81060-2 apply. | 0 ~ 294 mmHg |
| Measuring Range (Pulse) | Standard requirements per ISO 81060-2 apply. | 40 ~ 199 beats/minute |
| Patient Population | Adult | Adult |
| Measurement Site | Wrist | Wrist |
| Cuff Circumference | Relevant to performance validation with specific ranges. | 13.5 ~ 19.5 cm |
| Compliance Standards | ISO 81060-2 (for clinical validation and performance) | Complies with ISO 81060-2 |
Study Information
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Sample size used for the test set and the data provenance:
- The document states that the device was evaluated according to "AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
- ISO 81060-2 (which this document specifies compliance with) typically requires a minimum of 85 subjects for clinical validation to demonstrate agreement between the test device and a reference standard (e.g., a trained observer using a stethoscope). The document does not explicitly state the exact sample size used in the clinical study, but it is implied to be sufficient to meet the ISO 81060-2 standard.
- Data provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For clinical validation studies compliant with ISO 81060-2, at least two (and preferably three) trained observers are typically required to obtain simultaneous auscultatory reference measurements. These observers must be trained in the standard auscultatory technique for blood pressure measurement and follow the specified protocol (e.g., using a double stethoscope).
- Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in this document, but they would be healthcare professionals (e.g., physicians, nurses, or trained technicians) proficient in blood pressure measurement to serve as reference observers.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Clinical validation studies following ISO 81060-2 use simultaneous measurements with multiple observers. The standard outlines specific procedures for comparing the automated device's readings with those from the trained observers. For example, if two observers' readings differ by more than a specified amount, a third measurement or a re-measurement might be required, or the data point might be excluded. The standard's methodology effectively serves as an adjudication method.
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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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. Therefore, there is no effect size related to human reader improvement with/without AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The clinical validation per ISO 81060-2 specifically evaluates the algorithm/device's performance (its automated measurements) against reference measurements taken by trained human observers. The device itself operates as a standalone system to provide blood pressure readings.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical validation was established through expert auscultatory measurements performed simultaneously with the device's readings. This is the standard "reference measurement" method described in ISO 81060-2.
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The sample size for the training set:
- This document describes a premarket notification (510(k)) for a medical device. Blood pressure monitors like this typically use established algorithms based on oscillometric principles, not machine learning that requires a "training set" in the sense of AI models. Therefore, a specific "training set" sample size for an AI algorithm is not applicable here. The underlying algorithms are developed and refined through engineering, calibration, and extensive testing, but not typically "trained" on a dataset in the way an AI model would be.
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How the ground truth for the training set was established:
- As mentioned above, a "training set" in the AI sense is not applicable for this type of device. The accuracy and performance of the oscillometric algorithm are established through rigorous engineering design, mathematical modeling, and validation studies against established reference methods (like auscultation) in accordance with standards like ISO 81060-2.
§ 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).