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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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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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