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Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 17cm-48cm (approx, 6 11/16"- 18 29/32").

Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified. If any irregular heartbeat is detected, it can be shown to the user.

The provided FDA 510(k) summary for the "Fully Automatic Electronic Blood Pressure Monitor" pertains to a Class II medical device, specifically a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are outlined, primarily focusing on the device's accuracy in measuring blood pressure and pulse rate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors are typically defined by international standards like ISO 81060-2. While the exact numerical criteria for "Criteria 1" and "Criteria 2" are not explicitly stated in this document (e.g., mean difference and standard deviation), the document states that the device "met criteria 1 and criteria 2 of ISO 81060-2."

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

• Sample Size: 231 patients (107 males and 124 females) were invited for the study.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective, as patients were "invited for the study" and a "standard auscultation method was used as the reference blood pressure monitor measuring," indicating a controlled clinical trial setting.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals (e.g., doctors, nurses) using a stethoscope and sphygmomanometer. The qualifications of the individuals performing the auscultation are not detailed in this document.

4. Adjudication Method for the Test Set

• The document states that the "standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen." This suggests that the reference measurements were obtained sequentially. There is no mention of a multi-reader/adjudication method for resolving discrepancies in ground truth establishment, as the auscultation method itself is the direct reference measurement.

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 document describes the validation of an automated blood pressure monitor, not an AI-assisted diagnostic tool where human readers interact with AI. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not relevant to this device's validation.

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

• Yes. The study evaluates the "Fully Automatic Electronic Blood Pressure Monitor" directly against a "standard auscultation method." This is an assessment of the device's standalone performance, as it operates automatically to provide blood pressure readings without a human actively interpreting or modifying its output during the measurement process.

7. The Type of Ground Truth Used

• Expert Consensus/Reference Standard: The ground truth was established using the "standard auscultation method." This is considered the clinical gold standard reference for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a validation study for a medical device's performance, not the development or training of an AI algorithm. Blood pressure monitors with oscillometric principles are based on established engineering principles and typically do not involve a "training set" in the context of machine learning model development. The document refers to "non-clinical tests" and a "clinical test," which relate to verification and validation of the device's design and performance against standards.

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

• Not applicable. As noted above, this section is not relevant to the type of device and validation described.

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KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

The provided text describes the 510(k) premarket notification for the KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitors. The primary purpose of this submission is to demonstrate the substantial equivalence of these devices to a legally marketed predicate device (KD-7920).

The key study proving the device meets acceptance criteria is a clinical test performed in accordance with ISO 81060-2. This standard specifies requirements for the clinical validation of automated non-invasive sphygmomanometers.

Here's an organized breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for blood pressure monitors are typically defined by recognized standards such as ISO 81060-2. This standard sets forth statistical requirements for accuracy by comparing the device's measurements against a reference method (auscultation).

While the exact numerical acceptance criteria are not explicitly listed in a detailed table format within the provided document (e.g., mean difference and standard deviation), the text states that the device was verified by "meeting criteria 1 and criteria 2 of ISO 81060-2." These criteria specify the allowable differences between the device measurements and the reference measurements for systolic and diastolic blood pressure.

Table of Acceptance Criteria and Reported Device Performance (Inferred from ISO 81060-2 compliance):

Note: The exact numerical results (e.g., specific mean differences and standard deviations) from the clinical study are not provided in this 510(k) summary, only the statement that the device met the ISO 81060-2 criteria.

Study Details:

1. Sample size used for the test set and data provenance:

   • Sample Size: 85 patients (40 males and 45 females).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical validation according to ISO standards usually implies a prospective study conducted in a clinical setting.

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

   • The standard auscultation method was used as the reference blood pressure measurement. ISO 81060-2 requires two trained observers to perform the auscultatory measurements simultaneously and independently, or in a specific sequence, and their readings are averaged to establish the reference (ground truth).
   • The text does not specify the number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). However, for auscultation in such a study, the experts would typically be medical professionals trained and experienced in blood pressure measurement using the auscultation method.

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

   • The text states, "same sequential method was chosen." In the context of ISO 81060-2, the "sequential method" typically refers to the procedure where the test device and the reference (auscultation) measurements are performed one after another on the same subject. The standard generally requires two independent observers for auscultation, with their readings averaged or adjudicated if they differ beyond a certain threshold. The specific details of adjudication (e.g., 2+1) are not provided, but it's implied that the methodology adheres to the standard's requirements for establishing a reliable reference.

4. 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:

   • No. This is a study validating the accuracy of an automated non-invasive blood pressure monitor against a reference standard. It is not an MRMC study designed to evaluate how human readers (e.g., radiologists interpreting images) improve with AI assistance. Therefore, no effect size for human reader improvement is applicable or provided.

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

   • Yes, effectively. The "clinical test" described evaluates the accuracy of the automated blood pressure device itself (the "algorithm only" in a broader sense of an automated device) in comparison to a human-performed reference standard (auscultation). While a human applies the cuff and initiates the measurement, the blood pressure reading itself is generated by the device's internal algorithm. The study assesses the device's output independently, which parallels a "standalone performance" evaluation for an automated medical device.

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

   • The ground truth was established by the standard auscultation method (reference blood pressure monitor measuring), performed by medical professionals (experts). This falls under expert-derived reference standard/ground truth.

7. The sample size for the training set:

   • Not applicable / Not provided. The clinical study described in the 510(k) summary is for validation (test set performance), not for training. Blood pressure monitors like these are typically designed and calibrated during their development phase, which would involve internal testing and potentially specific datasets. The 510(k) submission focuses on the final performance validation.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. As mentioned above, the text describes the validation study, not the development or training phase of the device.

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KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-553, KD-557BR, KD-558BR, KD-5031M Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

This document describes the regulatory submission for KD-553, KD-557BR, KD-558BR, and KD-5031M Fully Automatic Electronic Blood Pressure Monitors, seeking substantial equivalence to a predicate device, KD-5920.

Here's an analysis of the provided text in relation to your questions:

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

The document primarily states that the device conforms to several international standards related to medical electrical equipment and non-invasive sphygmomanometers. It does not explicitly list specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or quantitative reported device performance values like mean difference or standard deviation. Instead, it states that "None of the test demonstrates that the new Blood Pressure Monitors bring new questions of safety and effectiveness." and that the devices are "substantially equivalent" to the predicate.

The relevant standards mentioned are:

• IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 - And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
• IEC 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
• IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers

The acceptance criteria would be that the device meets the requirements specified within these standards, particularly IEC 80601-2-30, which specifically deals with automated non-invasive sphygmomanometers. The reported performance is that the device "conforms" to these standards.

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 specify the sample size for any clinical or performance tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. It only mentions non-clinical tests.

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)

This information is not provided in the document. Given that the described tests are non-clinical and conformity to standards, human expert involvement in establishing ground truth for a test set (in the context of, for example, image interpretation or diagnosis) is unlikely to be relevant here. For blood pressure measurements, ground truth would typically be established by a reference measurement device or method in clinical studies, not by expert consensus on, for example, image interpretation. The document doesn't detail any clinical studies.

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

This information is not provided and is not typically relevant for the type of device and testing outlined (conformance to safety and performance standards for a blood pressure monitor).

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

An MRMC comparative effectiveness study is not mentioned and is not applicable to a fully automatic electronic blood pressure monitor, which does not involve human readers interpreting cases or AI assistance in diagnostic interpretation.

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

The device itself is described as a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner without human intervention once initiated for a measurement. The non-clinical tests relate to its performance in this standalone function (e.g., electrical safety, EMC, basic safety and essential performance per IEC 80601-2-30). However, the document does not explicitly describe a "standalone study" in the context of comparing its algorithm performance against a ground truth; rather, it indicates conformity to established performance standards.

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

The document does not explicitly state the type of ground truth used for performance evaluation. For blood pressure monitors, the "ground truth" in performance studies generally refers to measurements obtained using a validated reference method (e.g., auscultatory measurements using a mercury sphygmomanometer performed by trained observers conforming to specific protocols like those from the American Association for the Advancement of Medical Instrumentation (AAMI) or European Society of Hypertension (ESH)). The document only mentions conformity to standards like IEC 80601-2-30, which would implicitly require performance against such reference measurements as part of its testing protocols.

8. The sample size for the training set

This is not applicable to the information provided. The device is a traditional electronic blood pressure monitor, not an AI/machine learning device that would require a "training set" in the context of algorithm development.

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

This is not applicable as there is no mention of a training set or AI algorithm development.

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KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

The provided text describes the acceptance criteria and the study for the KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor.

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to compliance with particular standards, which implicitly define the acceptance criteria for certain performance aspects. The device characteristics are compared to those of a predicate device (iHealth View BP7S Wireless Blood Pressure Wrist Monitor, K152379) and a previous device (KD-972, K121470).

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

The document states that the clinical test report of KD-972 (cleared in 2012 as K121470) was used for evaluating KD-721/723. This implies retrospective use of clinical data.
The document states that KD-972 conformed to ANSI/AAMI/ISO 81060-2:2009 & 2013. These standards typically outline the requirements for clinical validation studies for automated sphygmomanometers, which involve a specific number of subjects. However, the exact sample size for the test set is not explicitly stated in the provided text. The data provenance is not specified beyond being from a previous device's clinical trial conforming to international standards (ANSI/AAMI/ISO 81060-2), which generally requires multi-center data from diverse populations.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Clinical validation studies for blood pressure monitors generally involve trained observers (often medical professionals) to perform reference measurements.

4. Adjudication method for the test set:

The document does not specify the adjudication method used for the test set.

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:

This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that involves human readers interpreting output. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.

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

Yes, a standalone performance evaluation was done through the reference to the KD-972 clinical test report, which conformed to ANSI/AAMI/ISO 81060-2:2009 & 2013. This standard specifically outlines the requirements for evaluating the accuracy of automated sphygmomanometers, which inherently tests the algorithm's performance in measuring blood pressure values.

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

The ground truth for blood pressure monitors in clinical validation studies conforming to ANSI/AAMI/ISO 81060-2 is typically established through auscultatory measurements performed by trained observers using a mercury sphygmomanometer or an equivalent reference device, often in a double-blinded protocol to minimize bias. This is a form of expert reference measurement.

8. The sample size for the training set:

The document states that the algorithm version (BPM-WAU V2.0-201109) is the same for KD-721/723 and the previously cleared KD-972. This implies that the algorithm was trained prior to the KD-972 clearance (K121470 in 2012). The sample size for the training set is not provided in this document, as the focus is on the clinical validation of the device using an existing algorithm.

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

Given that the algorithm is based on "oscillometric and silicon integrates pressure sensor technology" and is a "fully automatic" device, the ground truth for its original training would have been established through a combination of simulated data and clinical data where reference blood pressure measurements (e.g., auscultatory method by trained experts) were used to optimize the algorithm's performance in detecting systolic, diastolic, and pulse rate. The specific details of the training data and ground truth establishment are not provided in this document.

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KD-926 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-926 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-926 Fully Automatic Electronic Blood Pressure Monitor:

No specific acceptance criteria or performance numbers are explicitly stated in the provided document. The document primarily focuses on the substantial equivalence argument, referencing standards and prior clearances.

However, based on the mentioned standards (IEC 80601-2-30), we can infer the implied performance criteria that the device must meet to conform to these standards.

Inferred Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

Given the nature of the submission (510(k) for a blood pressure monitor) and the referenced standards, the primary acceptance criteria would revolve around the accuracy of blood pressure and pulse rate measurements.

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

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

The document states: "The cuff and algorithm of KD-926 is the same as K102939 and K120672, so we use the clinical data of K102939 and K120672 as the clinical proof of the new device."

• Sample Size: The sample size for the clinical data used for K102939 and K120672 is not specified in the provided document.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only indicates that "clinical data of K102939 and K120672" were used.

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

This information is not provided in the document. For blood pressure clinical trials, ground truth is typically established by trained observers using mercury sphygmomanometers as per recognized protocols (e.g., ANSI/AAMI/ISO 81060-2). The number and qualifications of these observers are not detailed here.

4. Adjudication method for the test set

This information is not provided in the document. For blood pressure clinical trials, multiple observers may be used, and their readings are often averaged or assessed for agreement, but the specific adjudication method is missing.

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

• No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Yes, a standalone (algorithm only) performance assessment was done. The clinical proof relies on the accuracy of the device itself (the "cuff and algorithm") against a reference standard, without human interpretation in the loop beyond initial application and reading of the reference. The device directly outputs blood pressure and pulse rate measurements.

7. The type of ground truth used

The type of ground truth used for validating blood pressure monitors is typically simultaneous measurements by trained observers using a reference standard device, such as a mercury sphygmomanometer or another validated oscillometric device, following an established protocol. While not explicitly stated, this is standard practice for devices conforming to IEC 80601-2-30.

8. The sample size for the training set

• Not applicable / Information not provided. As a standalone medical device measuring physiological parameters, it's unlikely to have a "training set" in the machine learning sense for the device's core function. The device's algorithm development involves calibration and validation against established physiological principles and clinical data, but not typically a "training set" for an AI model interpreting images or signals. The clinical data referenced (K102939 and K120672) serves as the validation/test set for the algorithm's accuracy.

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

• Not applicable / Information not provided. See the explanation for point 8.

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KD-7920 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

KD-7920 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

The provided text describes the submission of a 510(k) premarket notification for the "7920 Fully Automatic Electronic Blood Pressure Monitor." This document focuses on demonstrating that the new device is substantially equivalent to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure measurement system. The primary acceptance criteria for such a device are accuracy for systolic and diastolic blood pressure, and pulse rate. The document references compliance with ISO 81060-2 for clinical accuracy, which sets specific criteria for these measurements.

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

The document states that "Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2."

• Sample Size for Test Set: The specific sample size for the clinical test set is not explicitly stated in the provided text. However, ISO 81060-2 typically requires a minimum number of subjects (e.g., 85 subjects with specific demographic distribution, often involving both sexes and different age/BP ranges) and a certain number of measurements per subject for statistical validity.
• Data Provenance: The document does not specify the country of origin for the clinical test data. It is also not explicitly stated whether the study was retrospective or prospective, but clinical investigations for device approval are typically prospective.

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

The document references ISO 81060-2 for clinical accuracy. In such studies, ground truth for blood pressure is typically established by at least two independent, trained observers (experts) using a standardized auscultatory method (e.g., mercury sphygmomanometer calibrated against a reference) and adhering strictly to established protocols.

• Number of Experts: ISO 81060-2 typically requires two trained observers.
• Qualifications of Experts: The standard requires observers to be appropriately trained and certified in the auscultatory technique, demonstrating proficiency and inter-observer reliability before participating in the study. While specific qualifications like "radiologist with 10 years of experience" are not relevant for blood pressure measurement, the emphasis is on rigorous training and demonstrated competency in the reference measurement method.

4. Adjudication Method for the Test Set

For clinical blood pressure validation studies according to ISO 81060-2, the adjudication method generally involves:

• Simultaneous measurements: The device and the two expert observers take measurements simultaneously or in very rapid succession.
• Blinding: The observers are typically blinded to each other's readings and often to the device's readings. The device is also "blinded" if possible (e.g., automated capture without immediate display to the subject).
• Comparison of observer readings: The two observers' readings are compared. If they differ by more than a pre-defined threshold (e.g., 4 mmHg for SBP/DBP), a third observer or a re-measurement/adjudication process might be triggered, or the data point might be discarded. This helps ensure the reliability of the reference standard.

The specific adjudication method (e.g., 2+1, 3+1) is not detailed in the provided text, but it would have followed the requirements of ISO 81060-2 which mandates stringent protocols for reference measurements.

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

• No MRMC comparative effectiveness study was done. This device is a fully automatic electronic blood pressure monitor, which does not involve human readers interpreting diagnostic images or data in the same way an AI-assisted diagnostic tool would. The performance is assessed in standalone mode against a reference standard.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance assessment was done. The clinical test described as "Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2" is a standalone evaluation. This involved comparing the device's measurements directly against the auscultatory reference standard performed by trained observers, without any human-in-the-loop assistance for the device itself.

7. Type of Ground Truth Used

• The ground truth used for the clinical accuracy study was expert consensus auscultatory measurements. This method involves trained medical professionals (the two observers described in point 3) listening to Korotkoff sounds and recording the systolic and diastolic pressures, serving as the gold standard for non-invasive blood pressure measurement in validation studies.

8. Sample Size for the Training Set

• The document does not provide any information regarding a separate "training set" sample size. This type of medical device (an oscillometric blood pressure monitor) relies on an established algorithm (stated as "Amplitude (Same as K092510)") rather than requiring a continuously updated, large-scale machine learning training set in the way a modern AI diagnostic algorithm might. The algorithm would have been developed and refined using historical data, but the specific size of that foundational dataset is not mentioned or typically required for this type of submission.

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

• Similar to the above, information on how a "training set ground truth" was established is not provided. The device's algorithm is stated to be the same as the predicate device (K092510). This implies that the underlying algorithm was previously validated and established. The design principle is based on "oscillometric and silicon integrates pressure sensor technology," which uses physical principles and signal processing to derive blood pressure values, rather than being a learnable AI model from a labelled training dataset in the contemporary sense. Any initial development of such an algorithm would have involved comparisons to reference measurements, but specific details are not in this document.

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KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

The provided text is related to a 510(k) premarket notification for a blood pressure monitor and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information necessary to fully complete all aspects of the requested table and study description regarding acceptance criteria and performance against those criteria as would be found in a clinical study report.

However, based on the available text, here's what can be extracted and inferred:

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

The document references ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometers part 2: Clinical validation of automated measurement type as a standard met. This standard defines acceptance criteria for blood pressure measurement devices. While the exact acceptance criteria and the specific performance data against those criteria are not explicitly listed in a detailed table within the document, the mention of conforming to this standard implies that the device met its requirements.

The core acceptance criteria from ANSI/AAMI/ISO 81060-2:2009 typically involve:

• Mean difference: The absolute mean difference between the device measurements and auscultatory reference measurements should be ≤ 5 mmHg for both systolic blood pressure (SBP) and diastolic blood pressure (DBP).
• Standard deviation: The standard deviation of the difference between the device measurements and auscultatory reference measurements should be ≤ 8 mmHg for both SBP and DBP.

The document states: "None of the test demonstrates that KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness." and "KD-5920, KD-5920L and KD-5923 are very similar with its predicate device in the intended use, the design principle, the material, the performance...". This implicitly suggests that the device's performance aligns with the predicate device and meets the clinical validation standard's acceptance criteria. Specific numerical performance values are not provided in this document.

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 mentions "Non-clinical Tests have been done as follows:" and then lists standards. For clinical validation, it specifically mentions conformance to ANSI/AAMI/ISO 81060-2:2009. This standard requires a specific sample size for its clinical validation protocol, typically aiming for at least 85 subjects (some sources suggest minimum 35 to 85, depending on the specific protocol variant, but 85 is common for AAMI).

• Sample size for test set: Not explicitly stated, but conformance to ANSI/AAMI/ISO 81060-2:2009 implies a sample size that meets the standard's requirements (typically at least 85 subjects).
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Clinical validation studies conforming to such standards are generally 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)

For blood pressure measurement validation according to standards like ANSI/AAMI/ISO 81060-2, ground truth is established by simultaneous auscultatory measurements performed by at least two trained observers (usually clinicians).

• Number of experts: At least two trained observers.
• Qualifications of experts: Typically clinicians or blood pressure technicians highly trained in auscultatory measurement, following a standardized protocol (e.g., mercurial sphygmomanometer with stethoscope, double-headed stethoscope, etc.). Specific experience (e.g., specific number of years) is not mentioned in this document but is implicitly part of being "trained observers" in such a protocol.

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

For clinical validation of blood pressure devices using auscultation, the standard often involves:

• Two observers making simultaneous, blinded measurements.
• If the readings between the two observers differ by more than a predefined threshold (e.g., 4 mmHg), a third observer or a re-measurement may be required.
  This is a form of consensus/adjudication. The specific method used (e.g., direct average of two, third observer if discrepancy) is not detailed but is part of the standard's methodology.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance does not apply.

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

Yes, a standalone performance study was done. Blood pressure monitors are inherently standalone devices that provide a measurement directly. The reference to ANSI/AAMI/ISO 81060-2:2009 confirms that the algorithm (device) performance was evaluated against a reference standard.

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

The ground truth used for blood pressure measurement validation is expert auscultatory measurements (often referred to as reference measurements) taken simultaneously by trained observers using a mercury or calibrated aneroid sphygmomanometer. This is a form of expert consensus / reference standard as defined by the AAMI/ISO standard.

8. The sample size for the training set

This document does not specify a separate "training set" sample size. The device is validated against the AAMI/ISO standard; blood pressure monitors typically undergo calibration and internal testing during development (which might use various datasets), but the primary clinical performance assessment for regulatory purposes is the validation study, not a distinct "training set" in the context of machine learning.

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

As there is no explicitly mentioned "training set" in the context of the regulatory submission for this device type, the method for establishing its ground truth is not applicable or detailed in this document. The focus for regulatory submission is on the clinical validation/test set.

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KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N. KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. Achieves its function by an LCD.

The provided document is a 510(k) Premarket Notification from the FDA for a Fully Automatic Electronic Blood Pressure Monitor. It does not describe an AI medical device or provide the level of detail necessary to answer all parts of your request regarding AI acceptance criteria and study proving performance. The document focuses on showing substantial equivalence to a predicate blood pressure monitor.

However, I can extract information related to the device's performance validation as a non-AI medical device, based on the provided text.

Here's how I can address your request based on the available information, highlighting what is not applicable (N/A) for this type of device or not provided in the document:

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

The document states the device conforms to several standards, one of which is highly relevant for performance:

• ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type

This standard defines the acceptance criteria for clinical validation of automated non-invasive sphygmomanometers. While the document states the device will conform, it does not provide the specific reported performance data against these criteria in a table. It simply asserts compliance.

Therefore, for this device (a blood pressure monitor), the acceptance criteria would be those laid out in the ANSI/AAMI/ISO 81060-2:2009 standard. The document states compliance, but the specific performance results (e.g., mean difference and standard deviation of blood pressure readings compared to a reference method) are not explicitly listed in the provided text.

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

The document mentions clinical validation according to ANSI/AAMI/ISO 81060-2:2009. This standard typically requires a specific number of subjects (e.g., often a minimum of 85 subjects for the main validation) evenly distributed across different blood pressure ranges.

• Sample Size: Not explicitly stated in the provided text, but implied to be sufficient to meet the ANSI/AAMI/ISO 81060-2:2009 standard.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Clinical validation studies for medical devices are generally prospective.

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

For a blood pressure monitor, the "ground truth" is typically established by trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer).

• Number of Experts: Not explicitly stated, but typically involves two or more trained observers to establish reference measurements according to the validation standard.
• Qualifications of Experts: Not explicitly stated, but they would be clinicians/technicians trained in standardized blood pressure measurement techniques.

4. Adjudication method for the test set

For blood pressure validation studies, adjudication often involves averaging readings from multiple trained observers after ensuring inter-observer agreement.

• Adjudication method: Not explicitly stated, but implied to follow the methodology of ANSI/AAMI/ISO 81060-2:2009, which involves obtaining simultaneous or very close reference measurements from trained observers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, this is not applicable for a standalone blood pressure monitor. MRMC studies are typically for image-based diagnostic devices where human readers interpret images with and without AI assistance. This device is an automated measurement system.

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

• Standalone Performance: Yes, the fundamental performance evaluation of an automated blood pressure monitor is inherently "standalone" in that it measures blood pressure without direct human interpretation of a reading (other than taking the measurement itself). The validation according to ISO 81060-2 is a direct assessment of its accuracy against a gold standard.

7. The type of ground truth used

• Ground Truth Type: Clinical reference measurements from trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or another validated oscillometric device, as per the AAMI/ISO standard).

8. The sample size for the training set

The concept of "training set" is typically associated with machine learning/AI models. For a traditional medical device like this, there isn't a "training set" in the AI sense. The device's algorithms for blood pressure measurement are developed and refined during R&D, not typically "trained" on a data set in the same way an AI model is.

• Training Set Sample Size: N/A (not an AI device).

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

Since there is no "training set" in the AI context applicable to this device, this question is N/A.

In summary, the provided document is for a traditional, non-AI medical device. While it states compliance with relevant performance standards (like ANSI/AAMI/ISO 81060-2:2009), it does not provide the detailed study results or address AI-specific questions like training sets, MRMC studies, or multi-expert ground truth establishment for AI.

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KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

KD-726N. KD-737. KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. Achieves its function by an LCD.

The provided text describes the KD-726N (and other models) Fully Automatic Electronic Blood Pressure Monitor and its substantial equivalence determination by the FDA. Here's a breakdown of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

The device's performance is assessed against recognized standards, specifically ANSI/AAMI/ISO 81060-2:2009, "Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type." This standard sets the clinical validation criteria for automated non-invasive blood pressure measurement devices.

While the document explicitly states the device will conform to this standard, it does not provide a specific table of acceptance criteria with numerical targets and the reported device performance against these targets directly within the provided text. It only indicates that the device's performance was evaluated against this standard.

However, based on the ANSI/AAMI/ISO 81060-2:2009 standard, the general acceptance criteria typically involve:

• Mean difference between the device measurement and the reference measurement (auscultation): Usually, the mean difference should be within ±5 mmHg for both systolic and diastolic blood pressure.
• Standard deviation of the differences: The standard deviation of these differences should typically be 8 mmHg or less.

Therefore, without the actual study results included in this document, a table of acceptance criteria and reported device performance cannot be fully constructed. The document only confirms the intent to conform to the standard.

Study Details

The document states that the device's performance was evaluated to demonstrate that differences from the predicate device do not raise new questions of safety and effectiveness. This implies a clinical validation study was conducted in accordance with ANSI/AAMI/ISO 81060-2:2009.

1. Sample size used for the test set and the data provenance:

   • Sample size: The document does not specify the sample size used for the clinical validation test set.
   • Data provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical validation for such devices is typically prospective.

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

   • The standard ANSI/AAMI/ISO 81060-2:2009 dictates that reference measurements (ground truth) should be obtained by trained observers using auscultation. While the document doesn't explicitly state the number or qualifications of "experts" as in radiologists, it implies that the reference measurements were taken by trained personnel as per the standard. Specific details are not provided in this document.

3. Adjudication method for the test set:

   • The ANSI/AAMI/ISO 81060-2:2009 standard typically involves simultaneous auscultatory measurements by two independent observers (or more) to establish reference blood pressure, with a defined tolerance for their agreement. Discrepancies often require a third observer or specific rules for resolution. While the document does not explicitly state the adjudication method, adherence to this standard implies such a process.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

   • Yes, a standalone validation was performed. The clinical validation per ANSI/AAMI/ISO 81060-2:2009 evaluates the device's accuracy in measuring blood pressure compared to a reference standard (auscultation) without human intervention in the measurement process after the cuff is applied and the device is initiated.

6. The type of ground truth used:

   • The ground truth used for clinical validation in accordance with ANSI/AAMI/ISO 81060-2:2009 is expert auscultation, which involves trained human observers listening to Korotkoff sounds through a stethoscope to determine systolic and diastolic blood pressures.

7. The sample size for the training set:

   • The document does not provide information on a "training set." For an automated blood pressure monitor, the "training" (calibration, algorithm development) is typically part of the engineering and design process, and the clinical validation serves as the independent test set. The document focuses on the validation of the final device.

8. How the ground truth for the training set was established:

   • Since information about a specific "training set" and its ground truth is not provided, this question cannot be answered from the document. The inherent design and calibration within the device by the manufacturer would have relied on various forms of data and established metrology, but these are not described as a "training set" in the context of clinical validation in this document.

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KD-513LJ Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and system and is a rate of an adult individual by using a non-invasive technique in which and system one shound the supper and the supper and the supper and The cuff circumference is limited to 22cm-48cm.

KD-513LJ Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC80601-2-30--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. Achieves its function by an LCD .

The provided text is a 510(k) premarket notification for a medical device, specifically a Fully Automatic Electronic Blood Pressure Monitor (Model KD-513LJ). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document states that the device adheres to international standards for safety and performance, which act as the acceptance criteria. The performance summary explicitly mentions conformity to:

• IEC 60601-1:2005/EN 60601-1:2006/AC:2010: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010: Medical electrical equipment - Part 1-2: Electromagnetic compatibility.
• IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

These standards contain detailed specifications for accuracy, safety, and performance of blood pressure monitors. The document asserts that the device conforms to these standards, implying that it meets their respective acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

The document (specifically Section 8.0 "Discussion of non-clinical and clinical test performed") focuses on non-clinical tests performed to demonstrate safety and effectiveness. It does not describe a clinical study in the traditional sense of evaluating accuracy against a gold standard or a specific patient population, but rather conformance to recognized performance standards.

1. 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 provide information on the sample size for any clinical test set.
   • It does not specify the data provenance (country of origin, retrospective/prospective).
   • The "tests" mentioned are regulatory compliance tests (e.g., Electromagnetic compatibility, Electrical safety, Safety and performance characteristics of the test according to IEC 80601-2-30), not clinical performance studies with patient data.

2. 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/Not provided. The tests discussed are engineering and compliance tests against established standards, not studies requiring expert interpretation of medical images or measurements to establish a ground truth.

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

   • Not applicable/Not provided. As the tests are for regulatory compliance with standards, adjudications like those in clinical trials for diagnostic devices are not described.

4. 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:

   • No. This device is a blood pressure monitor, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC study is not relevant and was not performed.

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

   • The device itself is a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner to measure blood pressure. The "tests" (IEC 80601-2-30) evaluate its performance in this standalone capacity against reference standards. So, in a sense, the compliance testing is evaluating its standalone performance as a medical device. However, it's not a "standalone algorithm" in the context of AI without human interaction.

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

   • For blood pressure monitors, the "ground truth" for accuracy testing, typically required by standards like IEC 80601-2-30 for clinical validation, involves simultaneous measurements by a trained observer using a "reference" auscultatory method (e.g., Korotkoff sounds with a mercury or calibrated aneroid sphygmomanometer). The document does not explicitly state the specific ground truth method used for the performance testing, but implies compliance with IEC 80601-2-30, which mandates such a clinical validation.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/machine learning device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. As there is no "training set" for this type of device, this question is not relevant.

In summary, the document primarily focuses on demonstrating substantial equivalence to a predicate device and conformity to established international safety and performance standards for non-invasive blood pressure monitors. It does not detail specific clinical trial data or AI model validation methods.

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