(164 days)
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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.
They are designed and manufactured according to ANSI/AAMI SP10--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, 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 calculates the average of the last three measurements.
The provided text is a 510(k) summary for a Fully Automatic Electronic Blood Pressure Monitor. It includes information about device descriptions, intended use, and comparisons to predicate devices, but it does not contain the detailed clinical study information typically required to fully address your request in the context of advanced AI/medical imaging devices.
Specifically, for a blood pressure monitor, the "acceptance criteria" generally refer to accuracy standards set by organizations like AAMI (Association for the Advancement of Medical Instrumentation) or ISO (International Organization for Standardization). The study that proves the device meets these criteria would involve comparative measurements against a reference standard.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
The document states the device conforms to AAMI SP10:2002 (and its amendments), which is the standard for manual, electronic, or automated sphygmomanometers. This standard defines the acceptance criteria for accuracy.
| Acceptance Criteria (from AAMI SP10 standard) | Reported Device Performance |
|---|---|
| Accuracy for blood pressure measurement is defined by the AAMI SP10 standard. Typical criteria include mean difference and standard deviation between the device and a reference measurement. | The document states that the device conforms to AAMI SP10. However, it does not provide specific numerical results (e.g., mean difference, standard deviation) from a performance study for the subject device or its predicates. It implies satisfying the standard. |
2. Sample size used for the test set and the data provenance
The document mentions clinical tests were done for predicate devices and that those reports are applicable to the subject devices due to identical or similar design principles and algorithms.
- "The clinical test report of KD-598(K083395) is applicable to our subject devices."
- "the clinical test report of KD-5961 is applicable to KD-5031NJ."
However, the document does NOT provide the following specific details for the test sets:
- Sample size: Not explicitly stated for any of the devices.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For blood pressure monitors, the "ground truth" in clinical validation studies is typically established by trained observers using auscultatory methods with a mercury sphygmomanometer (or an equivalent reference standard) as per the AAMI SP10 protocol. The document does not detail how many observers were used or their qualifications for the underlying studies it references.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. In blood pressure validation studies following standards like AAMI SP10, often multiple trained observers measure blood pressure, and their readings are compared to ensure agreement, playing a role similar to an "adjudication method" in establishing the reference. However, the exact methodology is not detailed here.
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
N/A. This device is a fully automatic electronic blood pressure monitor, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the device itself is a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner, providing measurements without direct human interpretation in the measurement process. The clinical tests mentioned (conforming to AAMI SP10) would evaluate this standalone performance against a reference standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood pressure monitors, the ground truth is typically established by simultaneous measurements using a recognized reference standard, usually a mercury sphygmomanometer with trained observers using auscultatory methods, as defined by protocols like AAMI SP10. The document states conformance to AAMI SP10, which implies this type of ground truth methodology.
8. The sample size for the training set
N/A / Not provided. Blood pressure monitors based on oscillometric technology generally do not employ machine learning models in the same way modern AI systems do, which require "training sets." Their algorithms are typically fixed based on established physiological principles and signal processing. Therefore, the concept of a "training set" in the AI sense is not applicable to this device, or at least not described in the provided regulatory document.
9. How the ground truth for the training set was established
N/A / Not applicable for the reasons stated in point 8.
§ 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).