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The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

The Arm-Type series use an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. AND, these subject device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JOYTECH healthcare" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate, does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user.

The provided text is a 510(k) Summary for a blood pressure monitor and does not contain detailed information about a specific study proving the device meets acceptance criteria. Instead, it states that clinical testing was not required because the device is considered equivalent to a previously cleared predicate device (Joytech DBP-1307, K173024) due to having the same core algorithm and cuff circumference.

However, the summary does list the standards that were utilized for testing to demonstrate safety and effectiveness. The most relevant standard for performance claims is ISO 81060-2:2013, which covers the clinical validation of automated non-invasive sphygmomanometers. The document states that the clinical validation was performed according to ISO 81060-2:2013 for the predicate device.

Therefore, the information I can extract regarding the acceptance criteria and a study demonstrating compliance is limited. I will present the information available based on the provided text, primarily focusing on what ISO 81060-2:2013 generally entails for blood pressure monitors, as the detailed study specific to this device is not present but is referenced through the predicate.

Here's the breakdown of the information requested, based on the provided text and general knowledge of ISO 81060-2:2013:

1. Table of acceptance criteria and the reported device performance

Since the document states "clinical testing was not required to establish equivalency of the device" because it is based on the predicate device's validation per ISO 81060-2:2013, the acceptance criteria and performance would be those defined by this standard. The document does provide performance specifications for the device, which are implicitly stated to meet the requirements of the standards listed, including ISO 81060-2:2013 via the predicate.

2. Sample size used for the test set and the data provenance

The document explicitly states that "clinical testing was not required" for the new device because it is considered equivalent to the predicate device K173024 (Joytech DBP-1307), which had undergone clinical validation.

• Test Set Sample Size: Not provided in the document for the new device. For the predicate device, a clinical validation study adhering to ISO 81060-2:2013 would typically require a minimum of 85 subjects with specific distributions of age, sex, and blood pressure ranges.
• Data Provenance: Not provided for the new device. For the predicate device's clinical validation, it would have been prospective clinical data. The country of origin is not specified but is typically mentioned in clinical study reports.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information pertains to the clinical validation of the predicate device (DBP-1307, K173024) under ISO 81060-2:2013.

• Number of Experts: For ISO 81060-2:2013, ground truth is typically established by three trained observers taking sequential auscultatory measurements according to a defined protocol.
• Qualifications of Experts: The standard requires trained observers who are blinded to the device readings and are experienced in taking auscultatory blood pressure measurements. Specific medical qualifications (e.g., cardiologist, certified BP measurement technician) are usually detailed in the study protocol. The document does not specify their exact qualifications but implies they meet the standard's requirements.

4. Adjudication method for the test set

For the clinical validation of the predicate device under ISO 81060-2:2013:

• Adjudication Method: The standard specifies a method where the three observers conduct measurements. The ground truth (reference blood pressure) is derived from the average of the two closest readings among the three observers, or if there's a significant disagreement, specific rules are followed for exclusion or further measurement. This is a form of consensus-based ground truth.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not applicable to this device. This is a standalone blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation. The device provides automatic blood pressure readings.

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

• Standalone Performance: Yes, the fundamental performance of the blood pressure measurement algorithm is evaluated in standalone mode as part of the clinical validation process (for the predicate device). The device itself performs the measurement and displays the result without direct human interpretation of waveforms for diagnosis. While a human initiates the measurement and reads the display, the accuracy assessment is of the device's algorithmic output against a reference.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For the clinical validation of the predicate device (following ISO 81060-2:2013), the ground truth for blood pressure measurements is established by expert auscultatory measurements (Korotkoff sounds) by trained observers, as stated in point 3. This is a form of expert consensus derived from a gold standard manual method.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/Not provided. The document describes a medical device leveraging an established oscillometric method for blood pressure measurement, not a machine learning or AI model that requires a distinct training set in the conventional sense. The "core algorithm" of the device is validated against the predicate and established standards, rather than "trained" on a dataset in the way an AI model would be.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. As mentioned, this is not an AI/ML device that uses a distinct training set. The underlying oscillometric algorithm's principles are based on known physiological responses and signal processing, not on labeled training data. The validation of its performance (for the predicate device) uses auscultatory reference measurements as ground truth.

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