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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches (13.5 cm to 21.5 cm).

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Environments of Use: Home Patient Population: Adult

This device originally received clearance under 510(k) K123498.

The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure.

The device has a memory function that automatically stores up to 100 of the latest measurements. It can also display an average of the last three values

The device also detects the appearance of irregular heartbeats during measurement.

As originally submitted under 510(k) K123498, the device contained the APS feature. The feature was removed prior to clearance.

This submission is for the addition of the Advanced Positioning Sensor (APS) into the device. The APS is an aid to help the user determine if the cuff is at the correct height in relationship to the heart. The addition of APS does not change the intended use of the device. The addition of APS does not alter the fundamental scientific technology. There are no changes in hardware. There are no changes in the software algorithm which determines blood pressure or pulse rate. The addition of the APS feature is an optional feature which the user can elect to use. The APS feature does not alter the accuracy of the device, but serve to assist the user in positioning the device at the level of the heart.

The provided text describes the Omron BP652N (HEM-6300-Z) with APS, a noninvasive blood pressure measurement system. The submission (K142917) is for the addition of the Advanced Positioning Sensor (APS) feature.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states device specifications like "Accuracy of pressure indicator" and "Accuracy Pulse Rate" are identical to the predicate device. For clinical accuracy, it states a clinical study was performed in accordance with ANSI/AAMI/ISO 81060-2:2013. This standard typically defines specific criteria for mean difference and standard deviation of blood pressure measurements compared to a reference method (e.g., intra-arterial measurement or auscultation). While the exact numerical results for the Omron BP652N with APS are not provided in this specific excerpt, the submission implies that the device met the criteria of ANSI/AAMI/ISO 81060-2:2013.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions a "clinical study in accordance with ANSI/AAMI/ISO 81060-2:2013 was performed to validate the clinical accuracy of the device when the arm is positioned by use of the APS" (Page 4). However, the sample size of this clinical study is not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. ANSI/AAMI/ISO 81060-2:2013 usually mandates prospective clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• For non-invasive blood pressure measurement devices cleared under ANSI/AAMI/ISO 81060-2, the "ground truth" (reference measurement) is typically established by trained observers (experts) using a standardized auscultatory method. The standard typically requires a minimum of two trained observers to independently measure and record blood pressure, often blinded to each other's readings and the device's readings.
• The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, for compliance with ANSI/AAMI/ISO 81060-2, these would implicitly be highly trained individuals, often clinicians or technicians specifically trained in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

• For clinical studies following ANSI/AAMI/ISO 81060-2, if the two independent observers' readings differ by more than a pre-defined threshold (e.g., 4 mmHg or 5 mmHg), a third expert or an adjudication process is usually employed to resolve the discrepancy or additional measurements are taken.
• The document does not explicitly state the adjudication method used. However, compliance with ANSI/AAMI/ISO 81060-2 would imply a standardized method for managing observer discrepancies. A common method is for a third observer to perform a measurement, or for the initial two observers to reconcile their differences.

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

• No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor with an Advanced Positioning Sensor (APS). The APS is described as an "aid to help the user determine if the cuff is at the correct height in relation to the heart" and provides "visual feedback" (Page 4). It is not an AI algorithm that assists human readers in interpreting complex medical images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance evaluation was done for the core blood pressure measurement algorithm.
• The document states, "Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2: 2013 is documented in Section 20." (Page 9). This standard is specifically for evaluating the accuracy of automated sphygmomanometers (blood pressure monitors) against a reference method, which is a standalone performance assessment of the device's ability to accurately measure blood pressure.
• It also explicitly states, "The APS has no interface to the software algorithm which determines blood pressure or pulse rate, it is a visual feedback to the user indicating whether the device is positioned appropriately" (Page 4). This confirms that the blood pressure measurement algorithm operates independently of the APS feature.

7. The Type of Ground Truth Used

• For the clinical accuracy study performed in accordance with ANSI/AAMI/ISO 81060-2:2013, the ground truth for blood pressure measurements is typically established by a standardized auscultatory method. This involves skilled observers using a mercury sphygmomanometer or another validated reference method to listen for Korotkoff sounds.

8. The Sample Size for the Training Set

• The document describes the device already having a clearance (K123498) and this submission is for the re-addition of the APS feature. The core blood pressure algorithm was presumably "trained" or developed prior to these submissions.
• The document does not provide any information regarding a training set size for the blood pressure measurement algorithm or the APS, as it implies the algorithm itself is unchanged from the predicate device (K123498).

9. How the Ground Truth for the Training Set Was Established

• As the document does not provide information on a specific "training set" for the blood pressure algorithm in the context of this submission, it does not describe how ground truth for any training set was established. The algorithm's development and initial validation would have occurred prior to this 510(k) submission.

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