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The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".

HOCA EZ-CARE BP108 and TENDER-CARE BP109 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

The HOCA EZ-CARE BP108 and TENDER-CARE BP109 are noninvasive blood pressure measurement systems. The provided documentation does not include explicit acceptance criteria with numerical targets for device performance or a detailed study description with specific results. However, it does reference compliance with a standard related to electronic or automated sphygmomanometers, which implicitly defines performance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HOCA EZ-CARE BP108 and TENDER-CARE BP109 are implicitly based on compliance with the ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers standard. This standard typically defines accuracy requirements for blood pressure monitors.

However, the document does not explicitly state the numerical acceptance criteria or the reported device performance against these criteria in the form of specific accuracy (e.g., mean difference and standard deviation compared to a reference method). It only states that the device was tested against this standard and that its "accuracy" is a characteristic it shares with the predicate device.

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

The document does not specify the sample size used for any performance testing, nor does it detail the data provenance (e.g., country of origin or whether it was retrospective or prospective). It only mentions "Performance Testing" which includes adherence to ANSI/AAMI SP10-1992. Performance testing for blood pressure monitors typically involves clinical validation studies, but the details of such a study are not present in this document.

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

The document does not provide any information regarding the number of experts or their qualifications used to establish ground truth for any test set. For blood pressure devices, ground truth for clinical validation is typically established by trained observers using auscultation (Korotkoff sounds) with a mercury sphygmomanometer, often with double-blinded readings.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance

The device is a blood pressure monitor, not an AI-assisted diagnostic imaging or classification system that typically involves human readers interpreting cases. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance is not applicable to this type of device and was not mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone (algorithm only) blood pressure monitor that provides a direct reading. Its performance is evaluated as a standalone system. The document refers to "Performance Testing" with respect to relevant electrical safety and EMC standards, and the ANSI/AAMI SP10-1992 standard for electronic or automated sphygmomanometers, which addresses the standalone performance of such devices. The statement "Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure" implies a standalone performance evaluation.

7. The Type of Ground Truth Used

While not explicitly stated for a specific study in the document, for blood pressure monitors, the type of ground truth used in clinical validation studies conforming to standards like ANSI/AAMI SP10-1992 is typically expert consensus derived from auscultation using a calibrated mercury sphygmomanometer.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. Modern oscillometric blood pressure devices are developed using algorithms that are calibrated and validated, but the specifics of a "training set" in the context of machine learning (as often implied by this question) are not detailed here. The "simple calculation, clinically proven" phrase suggests a validated algorithm rather than a continuously "trained" AI model.

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

As no training set is mentioned, there is no information on how its ground truth was established.

Summary of Study Information:

The document primarily focuses on establishing substantial equivalence to a predicate device (Automatic Digital Blood Pressure Monitor, APM BP108A - K040159) based on shared characteristics including "intended use, technological characteristics, power supply, display, measuring range, accuracy, operating and storage environments."

The "Performance Testing" mentioned refers to compliance with:

• Electric Safety Requirement Test Report of EN 60601-1:1990
• EMC test report of EN 60601-1-2 (EN 55011:1991 and EN 61000-4-2:1995)
• ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers

The ANSI/AAMI SP10-1992 standard is the key reference for the accuracy performance of such devices. While the document confirms testing against this standard, it does not provide the specific numerical results of those tests or the details of the clinical study (e.g., subject count, methodology, statistical analysis). It relies on the predicate device's existing clearance which would have been based on such studies.

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