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KD-5963 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-7963 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 wrist. The cuff circumference is limited to 14cm-25cm.

KD-5963 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-7963 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 wrist. The cuff circumference is limited to 14cm-25cm.

It is 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, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5963 and KD-7963 are both 60 times. If any irreqular heartbeat is detected, it can be shown on the LCD, KD-5963 has the voice function, KD-7963 has the function of touch button and LCD backlight.

The provided text describes a 510(k) submission for two fully automatic electronic blood pressure monitors, KD-5963 and KD-7963. The submission focuses on demonstrating substantial equivalence to predicate devices (KD-5962 and KD-7962) rather than conducting a standalone clinical study to establish new performance criteria.

Therefore, the information required to fully answer the request, particularly regarding specific acceptance criteria, detailed study results (sample sizes, ground truth establishment, expert qualifications, MRMC studies, effect size, etc.), and standalone performance, is not present in the provided text. The document primarily highlights compliance with recognized standards.

However, I can extract the available information regarding compliance with standards, which can be interpreted as demonstrating that the device meets generally accepted performance criteria for blood pressure monitors.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

Study Proving Acceptance Criteria:

The document states that the devices (KD-5963 and KD-7963) "conform to the following standards" and that "the test in this submission provides demonstration that these small differences [from the predicate device] do not raise any new questions of safety and effectiveness." This implies that testing was conducted to verify compliance with the listed standards, particularly AAMI SP10, which governs the accuracy and performance of non-invasive blood pressure monitors.

Specific Details Not Available in the Provided Text:

The following requested information is not explicitly stated in the provided 510(k) summary:

• 2. Sample sizes used for the test set and the data provenance: The document mentions "the test in this submission" but does not detail the sample size (number of subjects, measurements) or the origin (country, retrospective/prospective) of the data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned, as a traditional ground truth adjudication process akin to image analysis wasn't described.
• 5. 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 is a blood pressure monitor, not an AI-assisted diagnostic tool for Human-in-the-Loop interpretation.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a "Fully Automatic Electronic Blood Pressure Monitor," implying standalone performance by design. However, the exact methodology and results of such a standalone performance test, beyond stating compliance with AAMI SP10, are not detailed.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, "ground truth" for accuracy studies typically refers to reference measurements obtained using a validated method (e.g., a mercury sphygmomanometer performed by trained professionals). While compliance with AAMI SP10 strongly implies such a ground truth was used, the specific details are not provided.
• 8. The sample size for the training set: Not applicable, as this is a device based on oscillometric technology and not a deep learning AI algorithm that requires a "training set" in the common sense.
• 9. How the ground truth for the training set was established: Not applicable.

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