(167 days)
KN-550, KN-550N ,KN-520 and KD-5005 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.
KN-550, KN-550N ,KN-520 and KD-5005Fully Automatic Electronic Blood Monitor. is designed and manufactured Pressure according to IEC80601-2-30--manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, 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. More over, it also obtains the function of averaging the measurement results. Achieves its function by an LCD or other display components.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KN-550, KN-550N, KN-520, and KD-5005 Fully Automatic Electronic Blood Pressure Monitors:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific numerical acceptance criteria for accuracy or performance figures from a clinical study. Instead, it relies on conformity to international standards, particularly IEC 80601-2-30.
The document states:
- "Safety and performance characteristics of the test according to IEC 80601-2-30"
- "Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010 (Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)"
Therefore, the acceptance criteria are implicitly defined by the requirements of IEC 80601-2-30, which specifies accuracy limits for automated sphygmomanometers. Without access to the full standard document, specific numerical criteria for bias and standard deviation cannot be extracted directly from this 510(k) summary.
Reported Device Performance:
The document does not report specific accuracy performance metrics like mean difference (bias) and standard deviation found in clinical validation studies. It only states that the device "conforms to" and "meets standards," implying that its performance is within the acceptable limits of IEC 80601-2-30.
| Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|
| Accuracy defined by IEC 80601-2-30 | Conforms to IEC 80601-2-30 |
| (Specific numerical limits for bias and standard deviation not provided in this summary) | (Specific numerical performance metrics not provided in this summary) |
| Electrical Safety | Conforms to IEC 60601-1 and IEC 60601-1-1 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 |
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 "Non-clinical Tests have been done as follows:" but then proceeds to list conformity to standards rather than detailing a specific clinical test with a sample size. It does not provide information on:
- Sample size for any test set (clinical or otherwise).
- Data provenance (e.g., country of origin).
- Whether any specific clinical data used for validation was retrospective or prospective.
The phrase "Safety and performance characteristics of the test according to IEC 80601-2-30" suggests that validation was performed following the standard's methodology, which typically involves clinical testing on a specified number of subjects. However, the details of that specific test (like sample size) are not provided in this summary.
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. For blood pressure monitors, ground truth is typically established by trained medical personnel using auscultation with a mercury sphygmomanometer, often with multiple observers for inter-observer variability, as per accepted validation protocols (e.g., ISO, BHS, AAMI). However, the details of such ground truth establishment for this specific device's validation are absent from this summary.
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 is not applicable to this device. The device is a "Fully Automatic Electronic Blood Pressure Monitor," which measures blood pressure automatically and does not involve human readers interpreting images or data where AI assistance would be relevant in an MRMC study context. There is no AI component mentioned for human assistance in this device description, nor any indication of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is marketed as a "Fully Automatic Electronic Blood Pressure Monitor," which inherently operates in a standalone manner without continuous human intervention during the measurement process. The conformity to IEC 80601-2-30 implies that its standalone performance (accuracy, safety) was assessed. However, the summary does not detail a specific "standalone study" in the context of an algorithm's performance as might be done for diagnostic AI. Here, "standalone" simply means the device performs its function by itself.
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 blood pressure monitors validated according to standards like IEC 80601-2-30, the ground truth for blood pressure measurements is typically established through simultaneous or sequential measurements by trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer or another validated device). This involves a comparative measurement against a highly accurate, often manually performed, technique.
8. The sample size for the training set
This information is not provided and is largely irrelevant for this type of device. Electronic blood pressure monitors are typically based on oscillometric principles, which are well-established algorithms that don't involve "training sets" in the machine learning sense for individual device models. The algorithms are usually developed and refined over time based on engineering principles and general physiological data, not specific training sets for a given 510(k) submission.
9. How the ground truth for the training set was established
This information is not provided and, as noted above, a "training set" in the context of machine learning is not applicable here. The underlying algorithms for oscillometric measurement are established physiological and engineering principles.
§ 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).