Search Results

The Citizen CH-502A and CH-502B finger sphygmomanometers are intended to be used for the oscillometric measurement of systolic and diastolic blood pressure and pulse.

The Citizen CH-502A and CH-502B finger sphygmomanometers are small hand-held noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's index finger. The units are contained in a hard plastic housing that contains a user interface panel and a finger cuff size adjuster slide. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse.

The provided 510(k) summary for the Citizen CH-502A and CH-502B Digital Finger Sphygmomanometers does not contain the detailed acceptance criteria and study data typically requested for a comprehensive evaluation. This document is a summary of the device's characteristics and its substantial equivalence to a predicate device, rather than a full study report.

However, based on the information provided, we can infer some details and highlight what is missing.

Inferred Information from the 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: These "acceptance criteria" are inferred directly from the performance specifications of the predicate device (Omron HEM-815F) which the Citizen devices claim to be substantially equivalent to. The summary states: "Both devices have a blood pressure measurement accuracy of the greater of ± 3mm Hg or ± 2% of the reading. The pulse measurement range of the Citizen devices and the Omron predicate are also the same... The accuracy of the pulse measurements for both the Citizen sphygmomanometers and the Omron predicate device are ± 5% of the measured pulse frequency." This implies that the Citizen devices are expected to meet these same performance standards to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The document is a 510(k) summary, which often summarizes testing without providing explicit sample sizes for clinical validation.
• Data Provenance: Not explicitly stated. Given the manufacturer's location (Japan) and the submission date (1995), it's likely the testing data would be from Japan, but this is not confirmed. It is also not stated if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided: For a blood pressure monitor, the "ground truth" is typically established by comparative measurements against a recognized standard method (e.g., auscultation by trained observers using a mercury sphygmomanometer) rather than expert consensus on images or diagnoses. The summary does not provide details on how the accuracy was assessed in a clinical study.

4. Adjudication method for the test set

• Not Applicable / Not Provided: As the ground truth would be objectively measured blood pressure readings, there wouldn't typically be an adjudication process involving multiple experts as seen in diagnostic imaging studies. The summary does not provide any details on adjudication.

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

• Not Applicable: This device is a standalone blood pressure monitor, not an AI-powered diagnostic tool intended to assist human readers. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes (Implied): The performance specifications provided (blood pressure accuracy, pulse accuracy) represent the standalone performance of the device without human interpretation or intervention beyond proper application. The device is designed to automatically measure and display these values. However, the study details of this standalone performance are not provided.

7. The type of ground truth used

• Inferred based on industry standards: For blood pressure monitors, the ground truth is typically a reference measurement from a validated standard method, such as auscultation by trained observers using a mercury sphygmomanometer, often following protocols like those established by the AAMI (Association for the Advancement of Medical Instrumentation) or BHS (British Hypertension Society). The summary does not explicitly state this, but it is the standard for proving accuracy.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not described as utilizing machine learning or AI that would require a separate "training set" in the modern sense. Its design is based on oscillometric principles and microcomputer control, which typically involve fixed algorithms, not learning models.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: As there is no explicit training set, this question is not applicable.

Ask a specific question about this device