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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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