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The KD-322 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time except infants and unconscious people, with the air cuff around the left upper arm according to instruction in the user's guide manual.

The KD-322 Semi Automatic Electronic Blood Pressure Monitor is intended to measure the diastolic and systolic blood pressures and pulse rate of an intended to modules the a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.

KD-322 Semi Automatic Electronic 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 device is used to monitor systolic, diastolic blood pressure and pulse rate which will be displayed on a LCD with an electronic interface. After wrapping the air cuff around the left upper arm 1-2cm above elbow joint, automatically inflated or inflated by an internal pump, the device can analyze the signals promptly and display the results.

Here's an analysis of the provided text to extract information about the acceptance criteria and the associated study for the KD-322 Semi Automatic Electronic Blood Pressure Monitor.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "...clinical tests were performed and complied the accuracy requirements of ... ANSt/AAMISP10-1992."

3. Number of Experts and Their Qualifications for Ground Truth

The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

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

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an automated blood pressure monitor, so an MRMC study in the context of human reader performance with or without AI assistance is not applicable.

6. Standalone (Algorithm-Only) Performance Study

Yes, a standalone study was done. The clinical tests performed were for the device itself to verify its accuracy against a recognized standard (ANSI/AAMI SP10-1992). The device is an "Automatic Electronic Blood Pressure Monitor," implying its function is standalone in measuring and displaying blood pressure and pulse rate.

7. Type of Ground Truth Used

Based on the reference to "ANSI/AAMI SP10-1992 Accuracy Requirements," the ground truth for the accuracy assessment would typically be established by a reference method or gold standard for blood pressure measurement, as specified within that standard. This often involves a trained observer taking auscultatory measurements using a mercury sphygmomanometer, though the document does not explicitly state this.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set. This is not surprising as the device described is a semi-automatic electronic blood pressure monitor, not an AI/ML-driven diagnostic device that typically requires a large training set in the conventional sense. Its "training" would be more about calibration and internal algorithm development rather than machine learning from labeled datasets.

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

The document does not provide information on how the ground truth for any "training set" was established, given the nature of the device as a measurement instrument rather than an AI/ML diagnostic.

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