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The KD-788 Wrist Measurement 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 6.1023 inches to 9.8425 inches.

KD-788 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an infernal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can divide into 4 groups and record 30 memory each group with the month, day and time of measuring.

Here's an analysis of the provided text regarding the KD-788 Wrist Measurement Electronic Blood Pressure Monitor, focusing on the acceptance criteria and the study proving it.

Important Note: The provided document is a 510(k) summary and FDA clearance letter. It states that clinical tests were performed, but it does not provide detailed reporting of the acceptance criteria nor the full study report. It only states that the device "complied with the accuracy requirements of ANSIIAAMISP10-1992" and "The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992." Therefore, I will derive the acceptance criteria from this standard and indicate where specific data would typically be found in a comprehensive study report, even if it's not present here.

Acceptance Criteria and Device Performance Study for KD-788 Wrist Measurement Electronic Blood Pressure Monitor

The KD-788 Wrist Measurement Automatic Electronic Blood Pressure Monitor is a non-invasive device intended to measure systolic and diastolic blood pressure and pulse rate at the wrist. The 510(k) submission, K052450, indicates that clinical tests were performed to demonstrate substantial equivalence and meet the accuracy requirements of the ANSI/AAMI SP10-1992 standard.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the ANSI/AAMI SP10-1992 standard, which is referenced, the acceptance criteria for automated sphygmomanometers typically involve two main components: mean difference and standard deviation of differences between the test device and a reference measurement (auscultation).

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

• Test Set Sample Size: The 510(k) summary does not explicitly state the specific number of subjects used in the clinical test set. The ANSI/AAMI SP10-1992 standard typically recommends a minimum of 85 subjects for validation studies. It is implied that at least this number, or more, was used to meet the standard's requirements.
• Data Provenance: The document does not specify the country of origin for the clinical data. Given the submitter's location (Tianjin, P.R. China), it is plausible the study was conducted there, but this is not confirmed. The study was prospective, as it involved performing clinical tests to evaluate the device’s accuracy.

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

• Number of Experts: The 510(k) summary does not explicitly state the number of experts used for ground truth. For blood pressure validation studies according to ANSI/AAMI SP10-1992, it is standard practice to use at least two trained observers (experts) to take auscultatory reference measurements.
• Qualifications of Experts: The document does not explicitly state the qualifications of the experts. However, per the AAMI standard, these observers would typically be trained healthcare professionals (e.g., nurses, physicians) who have demonstrated proficiency in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not explicitly describe the adjudication method used. For blood pressure validation, when multiple observers are used, a common method is to average their readings, or to use a specific protocol for assessing inter-observer variability, but the details are not provided here.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. This type of study (comparing human readers with and without AI assistance) is not applicable to an automated blood pressure monitor, which performs direct measurements rather than assisting human interpretation of images or signals. The device is designed for standalone measurement.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Performance: Yes, a standalone performance study was conducted. The clinical tests described in the K052450 summary relate directly to the accuracy of the device itself (KD-788 Wrist Measurement Electronic Blood Pressure Monitor) in measuring blood pressure and pulse rate, independent of human interpretation or assistance during the measurement process. The primary outcome was how well the device’s readings correlated with reference auscultatory measurements.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used would have been expert auscultatory measurements. This means trained human observers manually measured blood pressure using a stethoscope and sphygmomanometer, and these readings served as the reference standard against which the KD-788 device's readings were compared.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not explicitly mention a separate "training set" or its size. For a device like an automated blood pressure monitor based on oscillometric technology, the core algorithm is typically developed and refined using extensive datasets during the R&D phase. However, the 510(k) summary focuses on the validation or test set performance to meet the AAMI standard. Details of internal algorithm development and associated training data are generally not part of a 510(k) summary, which focuses on validation of the final product.

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

• Training Set Ground Truth: As with the training set size, the document does not provide details on how ground truth for any internal training data was established. Assuming standard practice, any internal data used for algorithm development and refinement would also have relied on expert auscultatory measurements or other well-established reference methods.

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