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Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

The Arm-Type Fully Automatic Digital Blood Pressure Monitor (Models: DBP-1204,DBP-1307,DBP-1332,DBP-1305,DBP-1334,DBP-1231,DBP-1314,DBP-1209,DBP-1303,DBP-1335) uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-36cm,22cm-42cm,32cm-48cm,select one. And the model DBP-1335 is comprised of 4 cuffs,22cm-36cm,22cm-42cm,32cm-48cm,33-43cm, select one.) which 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.

The provided document is a 510(k) Summary for a blood pressure monitor, not an AI/ML device. Therefore, many of the requested elements for acceptance criteria and study design for an AI/ML device (such as the number of experts used to establish ground truth, adjudication methods, MRMC studies, effect size of human readers with AI assistance, sample size for training set, and how ground truth for the training set was established) are not applicable and are not present in this document.

However, I can extract the relevant information regarding the clinical validation for the device's accuracy.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are derived from ISO 81060-2:2013, which specifies accuracy requirements for non-invasive sphygmomanometers. While the document states that the device complies with these requirements, it does not provide a table with specific numerical thresholds for acceptance criteria and the exact reported performance of the device against these thresholds. It only states that the clinical tests "comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample size used for the clinical validation. It mentions that clinical tests were performed for cuff sizes 22-42cm and 32-48cm. It does not provide information on the country of origin or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a blood pressure monitor, not an AI/ML diagnostic device requiring expert interpretation of images. The "ground truth" for blood pressure accuracy in such studies is typically established by trained observers using standardized auscultatory methods simultaneously with the device under test. The document does not specify the number or qualifications of these observers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable in the context of a blood pressure monitor accuracy study. The ISO 81060-2 standard outlines procedures for simultaneous measurements by trained observers and the device.

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 is not an AI/ML diagnostic device with human-in-the-loop performance.

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

Yes, a standalone performance assessment was done for the blood pressure monitor. Its accuracy was evaluated against the requirements of ISO 81060-2.

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

The ground truth for blood pressure measurements is established by trained observers using the auscultatory method (manual sphygmomanometry) as per the protocols outlined in standards like ISO 81060-2.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The device's algorithms for blood pressure measurement are based on established oscillometric principles, not trained on a dataset.

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

Not applicable, as there is no training set in the context of an AI/ML model for this device.

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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 wraps 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.

The provided document describes the acceptance criteria and a clinical study conducted to demonstrate the substantial equivalence of the JOYTECH Fully Automatic Digital Blood Pressure Monitor (K173024) to its predicate devices. The study aimed to prove the accuracy of the blood pressure monitors.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on the ISO 81060-2 Standard.
There are two methods for evaluation:

Method 1: Mean difference and standard deviation of differences.

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