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The INDEX™ BPM device is a tubeless blood pressure monitor. This is a medical device intended to measure systolic and diastolic blood pressure and pulse rate.

The INDEX™ BPM device is a tubeless blood pressure monitor.

I am sorry, but the provided documentation does not contain information about the acceptance criteria or any study details that prove the device meets these criteria. The document is an FDA 510(k) clearance letter and an "Indications for Use" statement, which primarily focuses on the regulatory aspects of the device, its intended use, and substantial equivalence to a predicate device, rather than detailed performance study results.

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The YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W are noninvasive blood pressurement systems 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 upper arm. The cuff circumference is limited to be 9.0" for Arm type.

YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W 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, 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.

Here's the breakdown of the acceptance criteria and study information for the YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the clinical test set. It mentions the application of standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009, which typically outline sample size requirements for blood pressure monitor validation. However, the exact number of subjects tested is not provided.

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

This information is not provided in the document. For blood pressure monitor validation, ground truth is typically established by trained observers (healthcare professionals) using a reference method, but the details are absent.

4. Adjudication Method for the Test Set

The adjudication method is not described in the provided text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This type of study is more common for diagnostic imaging AI systems to evaluate the impact of AI assistance on human reader performance. This document concerns a standalone blood pressure monitor.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was conducted. The device (BP-700NW and BP-700W) is designed to operate as a standalone device, taking measurements and displaying them. The performance tests against standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009 are evaluations of its automated measurement capabilities. No human-in-the-loop component is described for its fundamental operation or accuracy evaluation.

7. Type of Ground Truth Used

The ground truth used for the performance and clinical tests (i.e. those conforming to ANSI / AAMI SP 10: 2002, ANSI / AAMI ISO 81060-2:2009, EN 1060-4:2004) would typically be invasive blood pressure measurements or auscultatory measurements by trained observers using a validated reference method. However, the document does not explicitly state the type of ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, as this device uses the oscillometric method with microcomputer processing, not explicitly a deep learning or AI model that requires a separate training set. So, this information is not applicable in the traditional sense.

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

Since there is no "training set" described for a machine learning model, this information is not applicable. The oscillometric method relies on established physiological principles and algorithms, not necessarily on a training set in the AI sense.

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The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB are noninvasive blood pressure measurement systems 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 upper arm. The cuff circumference is limited to be 9.0" ~ 13.0" for Arm type.

YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB 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, 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 provided document describes the 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor (models BP-700 series). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for the device itself.

Based on the available information, here's an attempt to answer your questions, highlighting what is present and what is not:

Acceptance Criteria and Study for YA HORNG Digital Upper Arm Blood Pressure Monitor (BP-700 series)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., mean difference, standard deviation thresholds for blood pressure accuracy) or quantitative performance data from a clinical accuracy study for the BP-700 series.

Instead, it refers to overall compliance with standards:

• General Safety: EN 60601-1:1990+A1+A2+A11+A12+A13 – Reported as "PASS".
• EMC Conformity: EN 60601-1-2: 1993 – Reported as "PASS".
• FCC Conformity: ANSI C63.4: 2003 – Reported as "PASS".
• Blood Pressure Measurement Standard: EN 1060-1:1995, EN 1060-3:1997 – Reported as "PASS".
• Performance & Clinical Test Standard: AAMI / ANSI SP10 – The document states that the company "believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent." This implies that the device was tested against AAMI/ANSI SP10, and it passed, thereby meeting the clinical accuracy requirements outlined in that standard, but no specific numerical results are provided.

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

The document does not specify the sample size used for the clinical test set (i.e., the number of subjects). It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the company is based in Taiwan, it is plausible that the testing occurred there, but this is not confirmed.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitors tested against AAMI/ANSI SP10, ground truth (reference blood pressure measurements) is typically established by trained and certified observers using auscultation with a mercury sphygmomanometer or validated reference device.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method. In clinical studies for blood pressure monitors, if multiple observers are used for reference measurements, their readings are usually averaged or handled according to the specific protocol of the AAMI/ANSI SP10 standard.

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

Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation improvements.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was implicitly done. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" indicates that the device's accuracy in measuring blood pressure was evaluated independently against reference measurements, without human intervention in the device's measurement process. The device operates as an "algorithm only" in generating the blood pressure readings.

7. Type of Ground Truth Used

The ground truth used for blood pressure monitors compliant with AAMI/ANSI SP10 would be reference blood pressure measurements obtained through a validated method, typically auscultation by trained observers using a mercury sphygmomanometer or an equivalent validated reference device.

8. Sample Size for the Training Set

Not applicable. This is an automated measurement device and the document does not suggest the use of a machine learning model that requires a separate "training set" in the conventional sense (e.g., for image classification). The device uses the Oscillometric method, which relies on a pre-programmed algorithm based on physical principles, not on a machine learning model trained on a large dataset.

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

Not applicable, as there is no "training set" in the machine learning context for this device. The oscillometric algorithm is developed based on physiological principles and validated against known reference measurements.

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The Arm Type Digital Blood Pressure Monitor is a table top AC/DC powered operated arm type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the upper arm and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) blood pressure: 20 to 280 mmHg (2) pulse : 40 to 200 pulses/minutes.

The Ya Horng Arm Type Digital Blood Pressure Monitors, Types BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB , BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by oscillometric method in which an inflatable cuff is wrapped around the upper arm. It uses an electronic capacitive pressure sensor to convert tiny alternations in cuff pressure to electrical signals. It analyze those signals to define the systolic and diastolic blood pressure and calculating pulse rate. Some models are with RS232 or USB ports to connect to the personal computer to store the measured data.

The Ya Horng Arm Type Digital Blood Pressure Monitor (Models BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ) was evaluated for its accuracy in measuring blood pressure and pulse rate.

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the ANSI/AAMI SP-10-2002 standard for non-invasive blood pressure measurement systems. While specific numerical acceptance criteria from the standard are not explicitly stated in the provided text, the summary indicates that the "clinical effectiveness conforms to the standard." This implies that the device met the accuracy and reliability requirements outlined in ANSI/AAMI SP-10-2002.

2. Sample Size and Data Provenance

The provided text does not specify the sample size used for the clinical test set nor the data provenance (e.g., country of origin, retrospective or prospective). It only states "Discussion of clinical tests performed: The clinical effectiveness conforms to the standard of ANSI/AAMI SP-10-2002."

3. Number and Qualifications of Experts for Ground Truth

The provided text does not specify the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method

The provided text does not specify any adjudication method used for the clinical tests.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the device's standalone performance in accordance with a recognized standard, not on comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The "Discussion of clinical tests performed" section explicitly states that "The clinical effectiveness conforms to the standard of ANSI/AAMI SP-10-2002." This indicates that the device, operating as an algorithm-only system (without human-in-the-loop performance influencing its core measurement), underwent clinical testing against this standard. The device itself is described as using an "electronic capacitive pressure sensor to convert tiny alternations in cuff pressure to electrical signals. It analyze those signals to define the systolic and diastolic blood pressure and calculating pulse rate." This is the core algorithm being tested in a standalone capacity.

7. Type of Ground Truth Used

The type of ground truth used is implied to be clinical reference measurements that conform to the ANSI/AAMI SP-10-2002 standard. This typically involves simultaneous measurements taken by trained healthcare professionals using a validated reference method (e.g., mercury sphygmomanometry) against which the automated device's readings are compared.

8. Sample Size for Training Set

The provided text does not mention a training set or its sample size. The device relies on an "oscillometric method within the software algorithm," which is a known technique for blood pressure measurement rather than a new machine learning algorithm that typically requires explicit training data.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned for a machine learning model, the concept of establishing ground truth for a training set is not applicable here. The device's algorithm likely uses established principles of oscillometric blood pressure measurement.

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The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 are noninvasive blood pressure measurement systems 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 5.3" ~ 8.5" for Wrist type and 9.0" ~ 13.0" for Arm type.

YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J. BP-110J; and Digital Wrist Blood Pressure Monitor BP-500. BP-510 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, 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 provided 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and EMC standards. It makes a general claim about clinical performance but lacks detailed reporting to fully answer all the questions.

Here's a breakdown of what can be gleaned and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device meets AAMI / ANSI SP10 standards for performance and clinical testing. While it doesn't provide a table of precise acceptance criteria values and reported performance metrics for accuracy (e.g., mean difference and standard deviation in mmHg for systolic and diastolic pressure, as typically required by AAMI/ISO 81060-2), it implies that these standards have been met.

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

• Sample Size: The document does not explicitly state the sample size used for the clinical test (PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10). AAMI SP10 typically requires a minimum of 85 subjects for validation.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It just mentions "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10".

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

This information is not provided in the 510(k) summary. For AAMI SP10, ground truth is typically established by trained observers (e.g., physicians or nurses) using a reference sphygmomanometer following a specified auscultatory method. The number and qualifications of these observers are usually detailed in a full clinical study report, which is not available here.

4. Adjudication Method for the Test Set

This information is not provided. For AAMI SP10 validation, typically two or more trained observers measure blood pressure concurrently, and their readings are compared to ensure agreement, establishing a "ground truth" reference measurement. The adjudication method would describe how discrepancies between observers are handled, but this level of detail is absent.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned. This type of study (comparing human readers with and without AI assistance) is not typically performed for a standalone blood pressure monitor like this, which operates without human interpretation of complex medical images or data. The device provides a direct measurement.

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

Yes, this device is a standalone blood pressure monitor. The clinical performance refers to the device's ability to accurately measure blood pressure independently, without human interaction beyond operating the device. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" would assess this standalone performance against a clinical reference standard.

7. The Type of Ground Truth Used

Based on the reference to AAMI / ANSI SP10, the ground truth would have been established by expert auscultatory measurements (using a mercury or validated aneroid sphygmomanometer) typically by trained clinical personnel. This is the standard reference method for validating automated blood pressure devices.

8. The Sample Size for the Training Set

This information is not provided. Oscillometric blood pressure monitors rely on algorithms derived from physiological principles and extensive empirical data. There isn't typically a "training set" in the sense of machine learning models for image analysis. Instead, the algorithms are developed and refined using a large dataset of pressure waveforms and corresponding auscultatory reference measurements. The size of this underlying dataset used during the design and development of the oscillometric algorithm is not disclosed here.

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

As with the test set, the ground truth for any data used in the development or "training" of the oscillometric algorithm would have been established through expert auscultatory measurements synchronized with cuff pressure oscillations.

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The YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R are noninvasive blood pressure measurement systems 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 5.3" - 8.5".

Not Found

The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any details about acceptance criteria, a study proving device performance against those criteria, or any of the specific information requested in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC studies, standalone performance).

The 510(k) summary focuses on establishing substantial equivalence to a legally marketed predicate device (AMLUCK AUTOMATIC DIGITAL WRIST BLOOD PRESSURE MONITOR AK-3000 / AK-4000) based on similar indications for use and technology. It does not present a de novo clinical study with specific acceptance criteria and performance data as you've requested.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is primarily a regulatory submission rather than a detailed performance study report.

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The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model BP-410 and BP-420, are noninvasive blood pressure measurement systems 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 5.3" - 8.5".

YA HORNG BP-410 and BP-420 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, 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.

Here's an analysis of the provided information to describe the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details regulatory compliance and mentions performance standards but does not explicitly list specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference, standard deviation) or present a table of reported device performance in those terms.

Instead, it refers to:

• AAMI/ANSI SP10: This is the primary standard governing automated sphygmomanometers. Meeting this standard means the device's accuracy falls within internationally recognized benchmarks for blood pressure measurement.
• General Safety (EN 60601-1:1990+A1+A2+A11+A12+A13): This ensures electrical and mechanical safety.
• Performance (EN 1060-1:1995, EN 1060-3:1997): These are European standards specific to non-invasive sphygmomanometers, covering both general requirements and specific requirements for electro-mechanical blood pressure measuring systems.
• EMC Conformity (EN 60601-1-2: 1993): Ensures electromagnetic compatibility.

Given the available information, a table would look like this:

2. Sample Size for the Test Set and Data Provenance

The document states: "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10". While it indicates that a clinical test was performed to meet the AAMI/ANSI SP10 standard, it does not specify the sample size used for this test.

• Sample Size for Test Set: Not specified in the provided documents. (AAMI SP10 typically requires a minimum of 85 subjects with specific blood pressure ranges).
• Data Provenance: Not specified. The company is based in Taiwan, so it is possible the study was conducted there, but this is not confirmed. It is also not specified if the data was retrospective or prospective, though clinical trials for AAMI SP10 are typically prospective.

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

The document does not specify the number of experts or their qualifications for establishing ground truth.
For AAMI SP10 testing, ground truth for blood pressure is established by trained observers (often nurses or physicians) using a mercury sphygmomanometer or auscultatory method, typically following a specific protocol to minimize bias (e.g., sequential simultaneous measurements).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used. In AAMI SP10, blood pressure measurements are taken by two trained observers blinded to each other's readings, and the average or difference between their readings is typically used as the reference. Discrepancies beyond a certain point might require a third observer, but this specific method is not detailed here.

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

• No, an MRMC comparative effectiveness study was not done.
  The document describes a standalone clinical performance test against a standard (AAMI/ANSI SP10) to determine accuracy, rather than a study comparing human readers with and without AI assistance for interpretation. The device is an automatic blood pressure monitor, which directly provides readings, not an imaging or diagnostic AI tool that assists human interpretation.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done.
  The "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10" and compliance with "EN 1060-1:1995, EN 1060-3:1997" refer to studies performed on the device itself (the algorithm and hardware working together) to measure its accuracy against reference measurements. This is a standalone performance assessment of the device's ability to measure blood pressure without human interpretation beyond reading the displayed values.

7. Type of Ground Truth Used

The ground truth used for performance testing to AAMI/ANSI SP10 and EN 1060 standards is typically expert auscultatory measurements (manual blood pressure readings taken by trained clinicians using a reference device like a mercury sphygmomanometer). This could be considered a form of "expert consensus" in how multiple readings by experts are handled.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is typical for a traditional medical device (like a blood pressure monitor) that relies on fixed algorithms derived from physiological principles and extensive validation rather than machine learning models that require a distinct training phase.

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

Since no training set is mentioned or implied for this type of device, this information is not applicable and not provided. The device's algorithm would have been developed based on established oscillometric principles and then validated through testing against human reference measurements.

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The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

The provided document does not contain any information about acceptance criteria, device performance, or related studies. It is a K051539 510(k) clearance document for a blood pressure cuff and primarily focuses on administrative details, intended use, and the FDA's substantial equivalence determination.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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KD-575 Memory Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual.

The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model AK-3000T, 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 5.3" - 8.5".

KD-575 Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.

This document (K042581) is a 510(k) summary for two different blood pressure monitors, only one of which is addressed in the study. The information below pertains to the KD-575 Memory Automatic Electronic Blood Pressure Monitor from Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD. The second device from Ya Horng Electronic Co., Ltd. (AK-3000T) has its own separate information in the document beyond the scope of a unified description.

Acceptance Criteria and Study for KD-575 Memory Automatic Electronic Blood Pressure Monitor

The acceptance criteria for the KD-575 device are based on the accuracy requirements of the ANSI/AAMI SP10-1992 standard. The study performed directly assesses the device's adherence to these requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not provide specific numerical values for accuracy (e.g., mean difference and standard deviation) from the study. It only states a qualitative conformance to the standard.

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

• Sample Size: The document does not explicitly state the sample size used for the clinical tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states "Clinical tests were performed."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. For blood pressure monitors, ground truth is typically established by trained clinical personnel (e.g., physicians, nurses, or technicians) using auscultatory methods with a mercury sphygmomanometer or validated oscillometric devices as a reference, following a standardized protocol like the ANSI/AAMI SP10.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of blood pressure measurement studies where reference measurements are taken by clinical personnel, formal adjudication for ground truth (as might be seen in imaging studies) is less common, but specific protocols for obtaining and reconciling reference readings would be part of the study design.

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated.
• The study focuses on the standalone accuracy of the device against a standard, not on comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Yes, a standalone study was presented. The "Clinical Tests" section directly reports on the device's performance, stating it "complied with the accuracy requirements of ANSI/AAMI SP10-1992" and that "The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992." This indicates an assessment of the algorithm's performance without a human in the loop for measurement interpretation, only for operation.

7. Type of Ground Truth Used

The ground truth used for blood pressure monitor accuracy studies, such as those conforming to ANSI/AAMI SP10, is typically established through simultaneous or near-simultaneous measurements by trained observers using a validated reference method (e.g., auscultatory method with a mercury sphygmomanometer). While not explicitly stated as "expert consensus," the standard implicitly relies on trained human observers as the gold standard for comparison.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a traditional electronic blood pressure monitor based on oscillometric principles, not an AI/machine learning device that would typically have a separate "training set" in the computational sense. Its design and calibration are based on established physiological principles and engineering.

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

This information is not applicable as there is no mention of a training set for an AI/ML algorithm.

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The YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, Model AK-4000T, 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 5.3" - 8.5".

YA HORNG AK-4000T uses 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, 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, AK-4000T:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on establishing substantial equivalence to a predicate device and fulfilling electrical safety and EMC standards. It makes a general statement about clinical performance but does not explicitly lay out detailed numerical acceptance criteria for blood pressure measurement accuracy. However, it does refer to a recognized standard.

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

The provided text does not explicitly state a sample size for any clinical test set. It only mentions "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" without providing details of such a study.

Similarly, the data provenance is not specified. We do not know if the clinical data (if any was collected) was retrospective or prospective, or the country of origin.

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

This information is not provided in the document. As no detailed clinical test results are presented, there's no mention of how ground truth (e.g., reference blood pressure measurements) would have been established or by whom.

4. Adjudication Method for the Test Set

This information is not provided. Without details of a clinical test, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in these documents. This type of study is more relevant for diagnostic imaging or interpretation tasks, not typically for an automated blood pressure monitor.

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

The device itself is a standalone device in that it automatically measures blood pressure without direct human intervention in the measurement process. The document describes it as using the "Oscillometric method" where it "utilizes the microcomputer to automatically sense the characteristics of the pulse signal." However, the document does not report on a specific standalone performance study in isolation from the complete device functioning. It refers to the AAMI / ANSI SP10 standard, which would entail performance testing of the device as a whole.

7. The Type of Ground Truth Used

The document refers to the AAMI / ANSI SP10 standard for "PERFORMANCE & CLINICAL TEST." For blood pressure monitors, this standard typically requires simultaneous or near-simultaneous measurements using a recognized reference standard, such as a mercury sphygmomanometer with auscultation, often performed by trained observers. While the document doesn't explicitly state the ground truth used for its testing, adherence to AAMI/ANSI SP10 implies such a reference method would be used.

8. The Sample Size for the Training Set

The provided text mentions an "Oscillometric method" that "utilizes the microcomputer to automatically sense the characteristics of the pulse signal." This implies some internal algorithm or model. However, the document does not provide any information regarding a "training set" sample size for this algorithm, nor does it detail any machine learning components that would necessitate such a set. It's likely that the device's algorithms were developed through traditional signal processing and control rather than contemporary machine learning that requires distinct training sets.

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

Since no training set is described, information on how its ground truth was established is not provided.

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