(48 days)
The TF-BP01"" blood pressure monitor is intended for use in the home to measure systolic and diastolic blood pressures and pulse rate on adults aged 18 and older. Measurements are obtained using a non-invasive technique by placing an inflatable cuff around the wrist. The cuff circumference is 5.25 to 7.75 inches.
The TF-BP01™ 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 rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.
The provided 510(k) summary for the TF-BP01™ Blood Pressure Monitor indicates that the device's performance was assessed against the SP10 standard. This standard is used to validate the accuracy of non-invasive blood pressure monitors.
Here's a breakdown of the information requested, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from SP10 standard) | Reported Device Performance (TF-BP01™) |
|---|---|
| Criteria specified in SP10 standard for non-invasive blood pressure measurement devices. (Specific values for accuracy, bias, and standard deviation are not provided in this summary but are inherent to the SP10 standard) | The clinical test results met the criteria in the SP10 standard. |
Important Note: The provided 510(k) summary does not explicitly state the numerical acceptance criteria or the specific numerical performance results (e.g., mean difference, standard deviation) for systolic and diastolic blood pressure measurements as defined by the SP10 standard. It only states that the device "met the criteria in the SP10 standard." To get these specific values, one would need to refer to the full SP10 standard document and the complete test report submitted for the 510(k).
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical test results of the TF-BP01™ showed the functions of the device met the criteria in the SP10 standard." However, it does not specify the sample size used for the clinical test (test set) or the country of origin of the data. It also does not state whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth. For blood pressure monitor validation against a standard like SP10, typically, ground truth is established through simultaneous measurements by trained medical professionals using a reference (auscultatory or invasive) method.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. In the context of blood pressure monitor validation to a standard, adjudication methods are not typically described in the same way as for AI-driven image analysis. Instead, the SP10 standard outlines specific protocols for data collection and comparison to a reference method, which implicitly handles discrepancies.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
A Multi-reader Multi-case (MRMC) comparative effectiveness study was not done for this device. The document describes a validation against a recognized standard (SP10), not a comparison of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done. The entire premise of testing a blood pressure monitor against the SP10 standard is to evaluate the device's (algorithm's) accuracy in autonomously measuring blood pressure without human intervention influencing the measurement process itself. The "clinical test results of the TF-BP01™" refer to the automated performance of the device.
7. The Type of Ground Truth Used
The ground truth used would be simultaneous measurements by trained medical professionals using a reference method (likely auscultatory measurement with a mercury sphygmomanometer or an equivalent validated reference device), as per the SP10 standard. The SP10 standard dictates how these reference measurements are obtained and used to compare against the device's readings. The document refers to "clinical test results" meeting the "criteria in the SP10 standard," which implies this type of ground truth.
8. The Sample Size for the Training Set
The document does not mention a separate training set or its sample size. Blood pressure monitors using the oscillometric method are typically developed using algorithms trained and refined with various pressure waveforms and physiological data. However, the 510(k) summary does not provide details on the development or training phase of the algorithm, focusing solely on its validation against a standard.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, there is no information provided on how ground truth for a training set was established.
§ 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).