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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-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-734 series, KD-735 series, KD-7908, KD-7908V and KD-792RT 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-734 series, KD-735 series, KD-7908, KD-7908V and KD-792RT 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. They are designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD.

The provided FDA 510(k) summary for the Andon Health Co., Ltd. blood pressure monitors (KD-734, KD-735, KD-7908, KD-7908V, and KD-792RT series) does not contain detailed information about specific acceptance criteria for a clinical study or the results of such a study in a format that directly addresses the requested items (e.g., specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods).

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Andon Health Co., Ltd. KD-738 and KD-7962) and compliance with recognized standards. The key statements regarding clinical performance are:

• "The subject device KD-734 series, KD-735 series, KD-7908, KD-7908V and KD-792RT are identical to their predicate device KD-738 and KD-7962. The difference between the subject devices and their predicate devices do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-7901(K092510) is applicable to our subject device."
• The devices "are designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers." and "conforms to the following standards: ... AAMI SP10:2002, Manual, electronic or automated sphygmomanometers," along with its amendments.

This indicates that the clinical validation relies on the predicate devices' prior validation against the AAMI SP10 standard. The AAMI SP10 standard itself contains acceptance criteria for blood pressure measuring devices. For a specific clinical study conducted for these devices, the summary points to the "clinical test report of KD-7901(K092510)" as being applicable, but the details of that report are not included in the provided text.

Therefore, I cannot populate the table with specific reported device performance values directly from the text for these devices, nor can I provide the detailed study parameters (sample size, experts, ground truth type, etc.) as they are not explicitly stated in this document for the present devices but are referenced to a separate predicate device's clinical report.

However, I can extract what the implicit acceptance criteria are expected to be based on the reference to the AAMI SP10 standard. The AAMI SP10 standard sets forth requirements for the accuracy of blood pressure monitors.

Implicit Acceptance Criteria (based on AAMI SP10 standard) and Inferred Device Performance

The provided document states that the devices are "designed and manufactured according to ANSI/AAMI SP10" and "conforms to the following standards: ... AAMI SP10:2002". Therefore, the implicit acceptance criteria for clinical accuracy would be those defined by the AAMI SP10 standard.

AAMI SP10 Clinical Accuracy Criteria (summarized):

The AAMI SP10 standard typically requires:

• Mean difference: The mean difference between the device measurements and reference measurements (e.g., auscultation by trained observers) should be ±5 mmHg or less.
• Standard deviation: The standard deviation of the differences should be 8 mmHg or less.

Table of Acceptance Criteria and Inferred Device Performance:

Study Details (based on the provided text's limited information):

Due to the reliance on predicate device data and conformance to AAMI SP10, specific details for a new clinical study for these exact devices are not explicitly provided. The information below is either inferred or directly stated as absent/referenced externally.

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

   • Test set sample size: Not explicitly stated for these devices. The document references "The clinical test report of KD-7901(K092510) is applicable to our subject device." without providing details.
   • Data provenance: Not explicitly stated for these devices. For the predicate device, it would typically be prospective for clinical validation against AAMI SP10. The country of origin for the referenced KD-7901 study is not provided.

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

   • Not explicitly stated for these devices. For an AAMI SP10 validation, ground truth is typically established by multiple trained observers (e.g., physicians or nurses) using a mercury sphygmomanometer or equivalent reference device, following specific auscultatory protocols. The standard requires specific training and inter-observer variability checks for these experts.

3. Adjudication method for the test set:

   • Not explicitly stated. For AAMI SP10, typically multiple observers take readings, and the average or a consensus (e.g., if readings are within a certain range) is used as the reference measurement. Discrepancies might be resolved or excluded if they fall outside predefined limits.

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:

   • Not applicable/Not done. This is a blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data alongside AI.

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

   • Yes, implicitly. The clinical validation against AAMI SP10 measures the device's accuracy in autonomously determining blood pressure, compared to a reference method (human auscultation).

6. The type of ground truth used:

   • Expert Consensus (Auscultation): Per AAMI SP10, the ground truth for blood pressure is established by trained human observers using a mercury sphygmomanometer or equivalent, employing the auscultatory method.

7. The sample size for the training set:

   • Not applicable/Not provided. These devices are based on oscillometric technology and traditional signal processing for blood pressure determination, not machine learning or AI models that require a "training set" in the typical sense.

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

   • Not applicable (as described in point 7).

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