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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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