(276 days)
The KD-726 Memory Wrist 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 6.1023 inches to 9.8425 inches.
KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) document for the KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor:
Acceptance Criteria and Device Performance Study for KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor
The device demonstrated compliance with the accuracy requirements of ANSI/AAMI SP10-1992.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Test Type/Parameter | Required Performance (from ANSI/AAMI SP10-1992) | Reported Device Performance |
|---|---|---|---|
| ANSI/AAMI SP10-1992 | Accuracy | Meets or exceeds general accuracy requirements for non-invasive automated sphygmomanometers. | "The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992." |
Note: The 510(k) summary does not explicitly break down specific quantitative metrics (e.g., mean difference, standard deviation) for blood pressure accuracy as outlined in ANSI/AAMI SP10-1992. It broadly states compliance with the standard's accuracy requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the clinical test set.
The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not explicitly stated. It can be inferred that the study was likely prospective given it's a clinical test for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For blood pressure monitors, ground truth is typically established by trained observers using a reference standard like a mercury sphygmomanometer, not necessarily "experts" in the sense of radiologists.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. For blood pressure monitor accuracy studies, a robust methodology typically involves multiple trained observers taking readings and potentially averaging them or performing statistical comparisons to a reference. However, these specific details are not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For an automated blood pressure monitor, the focus is on the device's accuracy relative to a reference standard, not on human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical test described is inherently a standalone performance evaluation. The KD-726 is an automatic electronic blood pressure monitor, meaning its measurement is performed by the algorithm/device itself, without human intervention in the measurement process (though a human applies the cuff and initiates the reading). The clinical test assesses the accuracy of these automated measurements.
7. The Type of Ground Truth Used
Based on common practices for blood pressure monitor validation and the reference to ANSI/AAMI SP10-1992, the ground truth would typically be established by:
- Reference standard measurement: Simultaneous or near-simultaneous measurements taken by trained observers using a validated reference method (e.g., a mercury sphygmomanometer) on the same subjects.
- Expert consensus (implied for accuracy): While not 'expert consensus' in the typical imaging sense, the "correct" blood pressure readings used as ground truth would be agreed upon by qualified personnel following a standardized protocol.
The document itself does not explicitly state the type of ground truth beyond fulfilling the ANSI/AAMI SP10-1992 requirements, which implicitly defines the ground truth method.
8. The Sample Size for the Training Set
The document does not provide any information about a training set size. As an automated blood pressure monitor based on oscillometric technology, it is not a machine learning or AI device in the modern sense that typically requires a large 'training set' for model development. The device's algorithms are likely based on established physiological principles and signal processing, rather than learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of machine learning/AI, the question of how its ground truth was established is not applicable. The device's operational principles and algorithms would have been developed using engineering and physiological knowledge, not through a data-driven training process with ground truth labels.
§ 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).