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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

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.

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• Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
• Clinical settings: should be used under the instruction or prescriptions by . qualified health professionals prior to the applications of the device at home or hospital facilities.

Not Found

This document is a 510(k) premarket notification clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It does not contain information about a study proving the device meets acceptance criteria, an AI algorithm's performance, or any of the detailed metrics requested in your prompt.

Specifically, the document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Substantial equivalence (SE) is the primary pathway for 510(k) clearance. It means the new device is as safe and effective as a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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