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KD-5904 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 upper arm. The cuff circumference is limited to 22cm-48cm.

KD-5904 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm, the device can analyze the signals promptly and display the test results. It has some other functions, such as 6 buttons for operation.

Here's a breakdown of the acceptance criteria and the study information for the KD-5904 Fully Automatic Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The provided text only explicitly mentions that the device "meets the following standards: ANSI/AAMI SP-10 standard, EN60601-1 Medical electrical equipment Part 1: General requirements for safety, EN60601-1-2 Electromagnetic Compatibility."

The ANSI/AAMI SP-10 standard is the primary standard for non-invasive sphygmomanometers and outlines the accuracy requirements for blood pressure devices. While the exact numerical criteria from ANSI/AAMI SP-10 are not detailed in the provided documents, adherence to this standard implies meeting its specified accuracy requirements. Without the full standard document, the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) cannot be extracted.

Based on the provided text, the table below reflects what is stated:

Study Information

The document states that the device "meets the following standards: ANSI/AAMI SP-10 standard, EN60601-1 Medical electrical equipment Part 1: General requirements for safety, EN60601-1-2 Electromagnetic Compatibility." This implies that a study (or studies) was conducted to demonstrate compliance with these standards. However, the provided text does not offer specific details about the design, methodology, or results of such a study beyond the blanket statement of compliance.

Therefore, many of the requested details about the study are not available in the given document.

1. Sample size used for the test set and the data provenance: Not specified in the provided text.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. Blood pressure device validation typically involves comparing the device's readings to those of trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided text.
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. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself is a standalone system, and its performance would have been evaluated directly. The statement "KD-5904 Fully Automatic Electronic Blood Pressure Monitor meets the following standards: ANSI/AAMI SP-10 standard" implies a standalone performance evaluation against clinical reference measurements.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, the "ground truth" (or reference standard) in clinical validation studies is typically simultaneous measurements taken by trained observers using a calibrated Riva-Rocci/Korotkoff auscultatory method (often with a mercury sphygmomanometer) as defined by standards like ANSI/AAMI SP-10. However, this specific detail is not explicitly stated in the provided text.
7. The sample size for the training set: Not applicable/Not specified. For a device like this, which likely uses established oscillometric algorithms, there isn't typically a "training set" in the sense of machine learning models. The algorithm is developed and then validated against a test set.
8. How the ground truth for the training set was established: Not applicable/Not specified. See point 7.

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