(89 days)
The Transtek Blood Pressure Monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 23cm. It is intended for adult, indoor use only.
Transtek Wrist Blood Pressure Monitor, TMB-2072 is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Measurement method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a wellknown technique in the market called the "Oscillometric method". Transtek Wrist Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 23 cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump and the electromagnetic deflation control valve. The subject device is powered by 3.7V Built-in rechargeable lithium-ion battery. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. Transtek Wrist Blood Pressure Monitor TMB-2072 embeds a Bluetooth module that allows it to connect to nearby BT receiving end. The mobile application displays results. And once measurement is over, the device will start transmission data by BT. Thus, users can receive, and display/storage, measurement data from TMB-2072 unit through their end devices that embedded BT module.
The provided text describes the 510(k) submission for the Transtek Wrist Blood Pressure Monitor (Model TMB-2072). Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The primary clinical performance acceptance criteria for the blood pressure monitor are based on the ISO 81060-2:2018 standard for clinical validation of automated measurement type. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation thresholds) are not explicitly stated in the document, the conclusion indicates that the device met these criteria.
| Acceptance Criterion (Based on ISO 81060-2:2018) | Reported Device Performance |
|---|---|
| Mean error and standard deviation of differences for systolic blood pressure not exceeding specified limits. | "All data's mean error and standard deviation of differences for systolic... pressure is not over the limits of ISO 81060-2: 2018" |
| Mean error and standard deviation of differences for diastolic blood pressure not exceeding specified limits. | "...and diastolic pressure is not over the limits of ISO 81060-2: 2018" |
| Accuracy better than the predicate device. | "and the accuracy of subject device is better than predicate device." |
| No adverse effects/complications during the study. | "No adverse effect and/or complication is found in this study." |
Additional Performance Criteria (Non-Clinical):
The device also claims compliance with various non-clinical standards for electrical safety, electromagnetic compatibility, usability, and wireless testing. These are not presented in a table with specific acceptance values, but rather as statements of compliance.
2. Sample Size and Data Provenance
- Sample Size for the Test Set: 85 qualified healthy adult subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, based on the manufacturer's location (Guangdong, China) and the submission's context, it's highly likely the study was conducted prospectively in China.
3. Number of Experts and Qualifications for Ground Truth
The document specifies that the clinical study was conducted according to ISO 81060-2:2018. This standard typically requires "reference blood pressure measurements obtained by two trained observers using a reference sphygmomanometer against which the automated device measurements are compared."
- Number of Experts: The document does not explicitly state the number of experts used to establish the ground truth. However, based on the adherence to ISO 81060-2, it would involve at least two trained observers (likely medical professionals or technicians specifically trained in auscultatory blood pressure measurement).
- Qualifications of Experts: Not specified in the document, but ISO 81060-2 mandates "trained observers." These observers would be qualified to perform accurate auscultatory blood pressure measurements.
4. Adjudication Method for the Test Set
The document does not explicitly describe an "adjudication method" in the context of expert consensus (like 2+1 or 3+1). For blood pressure measurement validation under ISO 81060-2, the ground truth is established by concurrent measurements from reference sphygmomanometers read by trained observers. The standard outlines specific methods for comparing the automated device readings against these observer readings. Discrepancies between the two observers' readings typically have pre-defined limits within the standard, and if these limits are exceeded, the measurements might be discarded or re-taken. This is more of a concordance assessment rather than adjudication to resolve differing opinions on a single diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a standalone performance validation of the device against a reference standard (observers), not an assessment of human readers' improvement with or without AI assistance. The device in question is an automatic measuring device, not an AI-assisted diagnostic tool for interpretation by human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire clinical study described, based on ISO 81060-2:2018, is a standalone (algorithm only without human-in-the-loop performance) assessment of the device's accuracy in measuring blood pressure. The device's measurements were compared directly to the reference measurements obtained by trained observers.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus (from trained observers) using reference sphygmomanometers, as mandated by the ISO 81060-2:2018 standard. This is considered a gold standard for blood pressure measurement validation.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This submission is for a medical device that measures blood pressure using the "Oscillometric method," which is a well-established technique. While the internal algorithms of such devices are developed and likely refined using data, the document focuses on the clinical validation of the final device, not the development data. Therefore, details about a "training set" in the context of, for instance, a deep learning AI model, are not applicable or provided here.
9. How the Ground Truth for the Training Set Was Established
As noted above, information on a "training set" in the context of an AI model is not provided. For the clinical validation (test set) ground truth, it was established by trained human observers using reference sphygmomanometers following the protocols of ISO 81060-2:2018.
§ 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).