(69 days)
This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4 -- 8 1/2 inches).
This series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AFIA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 are 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 melhod 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 well-known technique in the market called the "Oscillometric method".
Transtek Wrist Blood Pressure Monitor is single-mounted device of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cun, includes the inflatable bladder and nylon shell. All four models of the wrist blood pressure monitor use the same size of cuff. The subject devices consist of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries.
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%.
The provided text is a 510(k) summary for the Transtek Wrist Blood Pressure Monitor. It does not contain information about a specific study comparing the device's performance against acceptance criteria beyond the general statement that "performance testing and assessment proved that the subject devices are safe and effective."
The document primarily focuses on establishing substantial equivalence to a predicate device (Omron, MODEL HEM-609N, K042505) by comparing features and performance parameters.
However, based on the Accuracy section in "Table 1: The difference between Transtek Wrist Blood Pressure Monitors" and "Table 2: The difference between Transtek Wrist Blood Pressure Monitor and Predicate HEM 609N", we can infer the acceptance criteria for accuracy.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
Based on the "Accuracy" row in the provided tables, the acceptance criteria for accuracy are:
| Feature | Acceptance Criteria | Reported Device Performance (Transtek TMB-895/TMB-988/TMB-1014/TMB-1117) |
|---|---|---|
| Pressure Accuracy | Similar to Predicate (Omron HEM-609N): Within ±3mmHg. |
The Transtek devices report:
- 5°C~40°C: within ±3mmHg
- 0°C
45°C (out of 5°C40°C): within ±5mmHg.
The summary states this is "Similar" to the predicate, implying the predicate itself has a ±3mmHg accuracy. It also implicitly sets these as the performance criteria for the Transtek device. | 5°C40°C: within ±3mmHg45°C (out of 5°C~40°C): within ±5mmHg |
0°C
| Pulse Value/Rate | Similar to Predicate (Omron HEM-609N): Within ±5% of reading. | Within ±5% of reading |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary only states that "performance testing and assessment proved that the subject devices are safe and effective" without detailing the methodology, sample sizes, or data provenance of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference standard like a mercury sphygmomanometer following a validated protocol (e.g., ISO 81060-2), but the details are not included here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of device (a wrist blood pressure monitor). This kind of study is typically used for medical imaging devices where human interpretation of images is a key component. This device directly measures physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the device is a standalone automaticsensing device. Its performance is evaluated based on its direct measurements without human intervention as part of the measurement process. The document implicitly refers to standalone performance through its accuracy claims.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth. However, for blood pressure monitors, the ground truth for accuracy testing is typically established by simultaneous measurements using a validated reference standard (e.g., a mercury sphygmomanometer or an equivalent oscillometric device that has been rigorously validated, applied by trained observers) alongside the device under test. This is standard practice for blood pressure monitor validation.
8. The sample size for the training set
This information is not provided in the document. Blood pressure monitors developed using the oscillometric method usually involve algorithms trained and validated on a diverse set of real-world blood pressure readings. However, no details on "training sets" are mentioned in this 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided in the document, as no "training set" is explicitly mentioned for this device.
§ 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).