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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.

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.

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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

Study Information

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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