(199 days)
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 13.5 cm~19.5 cm.
Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation, deflation 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.
The provided document is a 510(k) summary for an Automatic Wrist Blood Pressure Monitor (K193628). It addresses the safety and effectiveness of the device by establishing substantial equivalence to a predicate device (K151281).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the subject device (Automatic Wrist Blood Pressure Monitor, K193628) has the same performance specifications as the predicate device (AGE Automatic Wrist Blood Pressure Monitor, K151281). The acceptance criteria are implicit in the predicate device's performance, as the subject device claims "substantial equivalence" based on these matching specifications.
| Acceptance Criteria (Based on Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|
| Pressure Measuring Range: 0~294 mmHg | Pressure: 0~294 mmHg |
| Pulse Measuring Range: 40~199 beats/minute | Pulse: 40~199 beats/minute |
| Pressure Resolution: 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa |
| Pressure Measuring Accuracy: ± 3mmHg | ± 3mmHg |
| Pulse Measuring Accuracy: ±5% | ±5% |
| Cuff Circumference: 13.5~19.5cm | 13.5~19.5cm |
2. Sample size used for the test set and the data provenance:
The document mentions validation against standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. This standard outlines clinical validation requirements for non-invasive sphygmomanometers. While the document does not explicitly state the sample size used for this specific validation for the subject device, it implies that this standard was followed.
It also notes that the predicate device similarly conformed to this standard. For blood pressure monitors, clinical validation studies typically involve a specific number of subjects (e.g., at least 85 subjects as per ISO 81060-2:2018 requirements), with measurements taken by trained observers against a reference standard.
The data provenance is not explicitly stated as retrospective or prospective for the subject device's validation, but adherence to a clinical validation standard like ISO 81060-2 usually implies prospective data collection for the clinical study. The country of origin of the data is not specified for the clinical validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not directly state the number of experts or their qualifications for establishing the ground truth specifically for the subject device. However, compliance with ISO 81060-2 dictates the methodology for obtaining reference blood pressure measurements for clinical validation. This standard typically requires:
- A minimum of two trained observers (experts) to simultaneously obtain reference measurements using a calibrated auscultatory method.
- These observers need to meet specific training and accuracy criteria as outlined in the standard. While "radiologist with 10 years of experience" is not the relevant qualification here, the experts would be trained clinical professionals (e.g., physicians, nurses, or technicians) skilled in auscultatory blood pressure measurement.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not explicitly state the adjudication method. However, for clinical validation studies adhering to ISO 81060-2, the standard typically requires simultaneous auscultatory measurements by two trained observers. Discrepancies between the two observers that exceed a certain threshold usually necessitate a third observer, or the exclusion of that measurement. This is a form of 2+1 adjudication, or a similar method for ensuring accuracy of the reference standard.
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:
Not applicable. This device is an Automatic Wrist Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, implicitly. The device is an "Automatic Wrist Blood Pressure Monitor." Its core function is to automatically measure blood pressure and pulse rate without human intervention beyond placing the cuff and initiating the measurement. The validation against ISO 81060-2 is a clinical validation of the device's accuracy in a standalone capacity (i.e., comparing its automated readings to a reference standard).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for validating blood pressure monitors in accordance with ISO 81060-2 is expert auscultatory measurements (manual auscultatory method performed by trained observers) taken simultaneously or in quick succession with the device's measurements. This serves as the reference standard against which the automated device's readings are compared.
8. The sample size for the training set:
The document does not explicitly mention a "training set" or its sample size. For traditional medical devices like blood pressure monitors, while there is internal development and calibration, the term "training set" in the context of machine learning algorithms (as often seen with AI devices) is not typically used or disclosed in this type of regulatory submission. The focus is on the clinical validation of the final product.
9. How the ground truth for the training set was established:
As no explicit "training set" is discussed in the context of the device's regulatory submission in the provided text, the method for establishing its ground truth is not detailed. The primary regulatory focus for substantial equivalence is the clinical validation (test set) against established standards using expert auscultatory measurements as ground truth.
§ 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).