(171 days)
KD-721 and KD-723 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-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
The provided text describes the acceptance criteria and the study for the KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to compliance with particular standards, which implicitly define the acceptance criteria for certain performance aspects. The device characteristics are compared to those of a predicate device (iHealth View BP7S Wireless Blood Pressure Wrist Monitor, K152379) and a previous device (KD-972, K121470).
| Feature / Acceptance Criteria | Reported Device Performance (KD-721/723) |
|---|---|
| Pulse Rate Range | 40 - 180 times/min |
| Pulse Rate Accuracy | Within ±5% |
| Systolic Range | 60 - 260 mmHg |
| Diastolic Range | 40 - 199 mmHg |
| Pressure Accuracy | Within ±3 mmHg |
| Cuff Pressure Range | 0 - 300 mmHg |
| Overpressure Limit | 300 mmHg |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2:2014 |
| Electrical Safety | Complies with IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 |
| Safety & Performance Characteristics | Complies with IEC 80601-2-30:2009 & A1:2013 |
2. Sample size used for the test set and the data provenance:
The document states that the clinical test report of KD-972 (cleared in 2012 as K121470) was used for evaluating KD-721/723. This implies retrospective use of clinical data.
The document states that KD-972 conformed to ANSI/AAMI/ISO 81060-2:2009 & 2013. These standards typically outline the requirements for clinical validation studies for automated sphygmomanometers, which involve a specific number of subjects. However, the exact sample size for the test set is not explicitly stated in the provided text. The data provenance is not specified beyond being from a previous device's clinical trial conforming to international standards (ANSI/AAMI/ISO 81060-2), which generally requires multi-center data from diverse populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Clinical validation studies for blood pressure monitors generally involve trained observers (often medical professionals) to perform reference measurements.
4. Adjudication method for the test set:
The document does not specify the adjudication method used for the test set.
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 that involves human readers interpreting output. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done through the reference to the KD-972 clinical test report, which conformed to ANSI/AAMI/ISO 81060-2:2009 & 2013. This standard specifically outlines the requirements for evaluating the accuracy of automated sphygmomanometers, which inherently tests the algorithm's performance in measuring blood pressure values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for blood pressure monitors in clinical validation studies conforming to ANSI/AAMI/ISO 81060-2 is typically established through auscultatory measurements performed by trained observers using a mercury sphygmomanometer or an equivalent reference device, often in a double-blinded protocol to minimize bias. This is a form of expert reference measurement.
8. The sample size for the training set:
The document states that the algorithm version (BPM-WAU V2.0-201109) is the same for KD-721/723 and the previously cleared KD-972. This implies that the algorithm was trained prior to the KD-972 clearance (K121470 in 2012). The sample size for the training set is not provided in this document, as the focus is on the clinical validation of the device using an existing algorithm.
9. How the ground truth for the training set was established:
Given that the algorithm is based on "oscillometric and silicon integrates pressure sensor technology" and is a "fully automatic" device, the ground truth for its original training would have been established through a combination of simulated data and clinical data where reference blood pressure measurements (e.g., auscultatory method by trained experts) were used to optimize the algorithm's performance in detecting systolic, diastolic, and pulse rate. The specific details of the training data and ground truth establishment are not provided in this document.
§ 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).