(148 days)
KD-553, KD-557BR, KD-558BR, KD-5031M 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-553, KD-557BR, KD-558BR, KD-5031M 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.
This document describes the regulatory submission for KD-553, KD-557BR, KD-558BR, and KD-5031M Fully Automatic Electronic Blood Pressure Monitors, seeking substantial equivalence to a predicate device, KD-5920.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document primarily states that the device conforms to several international standards related to medical electrical equipment and non-invasive sphygmomanometers. It does not explicitly list specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or quantitative reported device performance values like mean difference or standard deviation. Instead, it states that "None of the test demonstrates that the new Blood Pressure Monitors bring new questions of safety and effectiveness." and that the devices are "substantially equivalent" to the predicate.
The relevant standards mentioned are:
- IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 - And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
The acceptance criteria would be that the device meets the requirements specified within these standards, particularly IEC 80601-2-30, which specifically deals with automated non-invasive sphygmomanometers. The reported performance is that the device "conforms" to these standards.
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 does not specify the sample size for any clinical or performance tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. It only mentions non-clinical tests.
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. Given that the described tests are non-clinical and conformity to standards, human expert involvement in establishing ground truth for a test set (in the context of, for example, image interpretation or diagnosis) is unlikely to be relevant here. For blood pressure measurements, ground truth would typically be established by a reference measurement device or method in clinical studies, not by expert consensus on, for example, image interpretation. The document doesn't detail any clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not typically relevant for the type of device and testing outlined (conformance to safety and performance standards for a blood pressure monitor).
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
An MRMC comparative effectiveness study is not mentioned and is not applicable to a fully automatic electronic blood pressure monitor, which does not involve human readers interpreting cases or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is described as a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner without human intervention once initiated for a measurement. The non-clinical tests relate to its performance in this standalone function (e.g., electrical safety, EMC, basic safety and essential performance per IEC 80601-2-30). However, the document does not explicitly describe a "standalone study" in the context of comparing its algorithm performance against a ground truth; rather, it indicates conformity to established performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for performance evaluation. For blood pressure monitors, the "ground truth" in performance studies generally refers to measurements obtained using a validated reference method (e.g., auscultatory measurements using a mercury sphygmomanometer performed by trained observers conforming to specific protocols like those from the American Association for the Advancement of Medical Instrumentation (AAMI) or European Society of Hypertension (ESH)). The document only mentions conformity to standards like IEC 80601-2-30, which would implicitly require performance against such reference measurements as part of its testing protocols.
8. The sample size for the training set
This is not applicable to the information provided. The device is a traditional electronic blood pressure monitor, not an AI/machine learning device that would require a "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
This is not applicable as there is no mention of a training set or AI algorithm development.
§ 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).