(49 days)
The Clever TD-3018A Blood Pressure Monitor provide intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
The CLEVER TD-3018A™ Blood Pressure Monitor is a wrist blood pressure monitor and uses the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and wrist cuff. The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the CLEVER TD-3018A™ Blood Pressure Monitor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Conformance to SP10 Standard | The device met the criteria in the SP10 standard for both non-clinical and clinical tests. | The SP10 standard is the relevant consensus standard for automated sphygmomanometers. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the sample size used for the clinical test set.
The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given 510(k) summary. For blood pressure monitors, ground truth is typically established by comparing the device's readings against a "reference" blood pressure measurement, often taken by trained observers using a mercury sphygmomanometer, not by "experts" in the typical AI sense.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary. For blood pressure monitors, adjudication methods usually refer to how multiple reference measurements are handled, e.g., averaging across multiple observers or repeat measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or described. This type of study is more relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. The CLEVER TD-3018A™ is a medical device for direct physiological measurement, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone blood pressure monitor that measures blood pressure using the oscillometric method. The clinical performance study described would inherently be a standalone performance evaluation of the device without human-in-the-loop assistance in the sense of a machine learning algorithm providing interpretations to clinicians. The "human-in-the-loop" for a blood pressure monitor would be the user initiating the measurement and reading the display, not an interpretive process.
7. Type of Ground Truth Used
The ground truth used for validating the device's performance against the SP10 standard would be reference blood pressure measurements. While not explicitly stated, the SP10 standard typically requires simultaneous or near-simultaneous measurements by trained observers using a validated reference method (e.g., mercury sphygmomanometer) against which the automated device's readings are compared.
8. Sample Size for the Training Set
The concept of a "training set" as it applies to machine learning algorithms is not applicable here. The TD-3018A™ Blood Pressure Monitor uses fundamental principles of oscillometric measurement, not a trained machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this type of medical device in the AI sense. The device's underlying algorithm is based on established oscillometric principles and calibration, not on learning from a dataset.
§ 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).