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The Automatic Blood Pressure Monitor is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 7.1 inches (18.0 cm) to 16.5 inches (42 cm).

The Automatic Blood Pressure Monitor (models: CH-S693L, CH-B601L, CP-B01, CH-S603, CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L) is a kiosk-type, automated, single upper-arm cuff oscillometric BP monitor developed for measurement of BP and pulse rate in healthcare facility/hospital or at home.

It is designed for BP measurements on either the right or left upper arm and has a fixed tubular (Arm barrel) opening to insert the user's arm, with an integral single-arm cuff, which when inflated surrounds the upper arm. It is suitable for arm circumference range 18~42 cm. The device has an elbow groove to ensure correct positioning of the arm and measures BP during inflation. A wide LED screen presents systolic and diastolic BP, heart rate and time of measurement. After the user pushes the start button, the cuff is inflated automatically by an internal pump, the systolic and diastolic blood pressures are determined by oscillometric method.

Principle of operation:

The product uses the Oscillometric Measuring method to detect blood pressure.

When the user presses the "START" button to initiate the measurement, the winding mechanism, driven by a geared motor, begins to operate. It stops winding when it starts to encounter resistance from the arm. At this point, the cuff is adapted to the arm size. Subsequently, the cuff is automatically inflated by an internal pump to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.

This document is a 510(k) clearance letter for an Automatic Blood Pressure Monitor, which means it describes a non-invasive blood pressure measurement system, not an AI/ML device in the context of the requested questions. The provided text is a standard FDA 510(k) summary for a traditional medical device and does not contain information about AI model performance, expert ground truth adjudication (for AI), or MRMC studies.

Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text because they pertain to AI/ML device studies, which is not what this document describes.

However, I can extract information related to the device's performance based on the provided clinical accuracy testing for the Automatic Blood Pressure Monitor.

Acceptance Criteria and Device Performance (Non-AI/ML Device):

The device's clinical accuracy was tested according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01. The document explicitly states:

"The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01."

This standard outlines the requirements for clinical investigations of intermittent automated measurement type non-invasive sphygmomanometers. While the specific numerical performance metrics (e.g., mean difference and standard deviation of differences between device and reference measurements) are not quantitatively stated in the summary table, the statement of compliance confirms that the device met the acceptance criteria defined by this international standard for blood pressure measurement accuracy.

The summary also specifies instrumental accuracy for blood pressure and pulse rate:

• Blood Pressure Measurement Accuracy: ±3 mmHg
• Pulse rate measurement accuracy: ±5%

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Regarding the specific questions about AI/ML studies:

1. A table of acceptance criteria and the reported device performance: See table above. More specific quantitative clinical performance results (e.g., mean difference and standard deviation of differences of BP readings compared to reference) are not explicitly detailed in the provided summary but are implied by the compliance statement.
2. Sample size used for the test set and the data provenance:
   • Test Set Sample Size: 85 subjects.
   • Data Provenance: Not specified (e.g., country of origin). It's a clinical trial, implying prospective data collection for the validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is for a traditional blood pressure monitor validated against a reference sphygmomanometer (aneroid/auscultation method), not an AI/ML device requiring expert consensus for ground truth. The reference device was a "CM-BPM-D Aneroid sphygmomanometer" by Shanghai Caremate Medical Device Co. Ltd.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device and study. The accuracy is determined by comparison to the reference measurements.
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 a traditional medical device, not an AI/ML product assisting human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone automatic blood pressure monitor. Its performance is measured directly, not as an algorithm's output to be interpreted by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the clinical accuracy study was established by measurements from an "Aneroid sphygmomanometer" using the "Aneroid/auscultation method." This is the established reference method for validating automatic BP monitors per ISO 81060-2.
8. The sample size for the training set: Not applicable. This is a traditional device; there is no "training set" in the AI/ML sense. The device's measurement algorithm is predetermined and fixed.
9. How the ground truth for the training set was established: Not applicable. No AI model training set.

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The Scian Automatic Digital Blood Pressure Monitor, Models LD-518 & LD-537, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Scian Automatic Blood Pressure Monitor, Models LD-518 & LD-537. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or the specific data requested in your prompt.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of human readers with AI assistance.
6. Information on a standalone algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval letter, not a clinical study report. To obtain the information you're looking for, you would typically need to refer to the 510(k) submission summary or associated clinical validation studies that would have been part of the manufacturer's submission to the FDA.

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The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

Not Found

The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device's intended use and FDA clearance, but it does not contain the detailed study information needed to answer your request about acceptance criteria and study proving device performance.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information about the sample size, data provenance, number of experts, adjudication method, or ground truth used for performance studies.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• Details regarding the training set size or how its ground truth was established.

This document primarily serves as an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. To get the information you asked for, you would need to consult a different document, such as the actual clinical or performance study report submitted to the FDA, which is not provided here.

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The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.

The EX PLUS 1300 is a blood pressure monitor to non-invasively measure blood pressures and heart rate at the brachial site(s). The device employs oscillometric method. The device is a microprocessor-controlled and includes an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, LCD display of systolic and diastolic pressure readings and heart rate, and push buttons. The device employs a pressurement algorithm designed to detect, filter, process, and store pressure readings. The electronic deflation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EX PLUS 1300 is an AC adapter-powered.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Jawon Automatic Blood Pressure Monitor, Model EX PLUS 1300:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with the ANSI/AAMI Voluntary Standard, SP-10:2008. While the specific numerical acceptance criteria for blood pressure monitors according to this standard are not fully detailed in this document, the performance specifications provided are implicitly part of meeting this standard.

Important Note: The stated "Accuracy - pressure: +/- 2mmHg" is often interpreted as the device's inherent precision or resolution. The actual AAMI SP-10 standard for accuracy involves statistical analysis of the difference between device readings and a reference method (auscultation by trained observers), where the mean difference and standard deviation of differences are the key metrics. The document implies compliance with the standard but does not provide these specific statistical results for validation of the EX PLUS 1300 model itself.

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

• Test Set Sample Size: No new clinical test data for the EX PLUS 1300 is provided. The document explicitly states: "The EX PLUS 1300 was not clinically tested because the device uses the identical software codes and pressure detection related hardware as the predicate device to determine systolic, diastolic, and pulse rate." And "As the modified device EX PLUS 1300 comprises of two sets of EASY X 900(R/L) of which are predicate device, no clinical test was conducted."
• Data Provenance: Not applicable as no new clinical data was collected for this specific device. The clinical validation of the predicate device (EASY X 900(R/L)) would have involved data, but its provenance is not detailed here.

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

• Not applicable as no new clinical study was conducted for the EX PLUS 1300. The ground truth method for the predicate device's validation (likely expert auscultation according to AAMI SP-10) is not detailed here.

4. Adjudication Method:

• Not applicable as no new clinical study was conducted for the EX PLUS 1300.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The device's validation relies on its substantial equivalence to a predicate device and engineering/non-clinical testing.

6. Standalone Performance Study:

• A standalone clinical performance study was not done for the EX PLUS 1300. The submission argues that because the EX PLUS 1300 uses "identical software codes and pressure detection related hardware" as the predicate device (Jawon Model EASY X 900(R/L)), and is essentially "two (2) sets of model EASY X 900(R/L) in one enclosure," a new clinical test was not required. The performance specifications are given for the EX PLUS 1300, but they are based on the proven performance of the predicate device.

7. Type of Ground Truth Used:

• For the EX PLUS 1300, no new clinical ground truth was established. For the original predicate device validation (EASY X 900(R/L)), the ground truth for blood pressure measurement according to ANSI/AAMI SP-10 typically involves simultaneous auscultation by multiple trained observers using a mercury sphygmomanometer as the reference standard.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. It's an oscillometric blood pressure monitor.

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

• Not applicable as this is not an AI/ML device requiring a training set.

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