(29 days)
KD-5913 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-5913 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 am. The cuff circumference is limited to 22cm-48cm.
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. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also has the function of averaging the last three measurements.
The provided 510(k) summary for the KD-5913 Fully Automatic Electronic Blood Pressure Monitor does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study proving device performance.
This document focuses on establishing substantial equivalence to a predicate device (KD-5917). It states that the device conforms to certain standards, but it does not provide a specific performance study with detailed acceptance criteria, test results, or methodology as would be expected for a comprehensive performance study.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the device "conforms to" several standards, including:
- AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
- AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanoment.
- AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanoment.
These standards typically define the acceptance criteria for blood pressure monitors (e.g., accuracy against a reference standard, standard deviation of differences). However, the document explicitly states "Performance summary" but then only lists the standards to which the device conforms, without providing the actual measured performance data or the specific acceptance criteria derived from these standards. It also does not explicitly state the reported device performance in terms of accuracy metrics (e.g., mean difference, standard deviation) against a reference.
Therefore, a table of acceptance criteria and reported device performance cannot be created from the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." However, it does not specify the sample size used for any performance testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Blood pressure monitor validation studies typically involve medically trained personnel taking reference measurements, but the specifics are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool requiring "human readers." Therefore, an MRMC study is not applicable, and no such study or effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is designed to operate standalone as a "Fully Automatic Electronic Blood Pressure Monitor." Its performance would inherently be a standalone assessment. However, the document does not provide the results of such a standalone test, only that it conforms to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated, for blood pressure monitors conforming to standards like AAMI SP10, the "ground truth" for accuracy validation is typically established through simultaneous measurements by trained observers using a reference manual sphygmomanometer (auscultatory method), as per the requirements of such standards.
8. The sample size for the training set
This device is not described as an AI/ML device that requires a "training set." Its operation is based on oscillometric and silicon integrate pressure sensor technology. Therefore, the concept of a "training set" as it applies to AI/ML is not applicable here, and no information about it is provided.
9. How the ground truth for the training set was established
As "training set" is not applicable, this question is not relevant.
In summary, the provided document serves as a 510(k) summary for substantial equivalence. It confirms adherence to relevant performance standards but does not detail the specific performance study, including acceptance criteria, sample sizes, ground truth establishment, or test results, which would be found in a more comprehensive testing report.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).