(95 days)
Transtek Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Device RPM-BP100SBP and H-BP100SBP are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 15 cm to 54 cm (about 6-21 inches).
These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
Contraindications:
This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.
These device are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Blood Pressure Monitor TMB-1591-A, Welch Allyn Blood Pressure Transtek Device RPM-BP100SBP and H-BP100SBP 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 arm. The three devices are the same except brand name, model number and the layout of labeling.
Measurement method to define systolic and diastolic pressure is similar to the ausculatory 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 well-known technique in the market called the "Oscillometric method".
These devices also compare 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%.
These devices include the main unit and cuff unit. The main unit consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. ABS is used to outer housing of the main unit. The three preformed cuff units, which are applicable to arm circumference between 15-24cm, 22-42cm and 40-54cm to meet different population's need. The subject device is powered by four AA alkaline batteries or by a DC 6V 1AA adapter.
These devices embed a Bluetooth module that allows it to connect with nearby BT receiving terminal (such as iphone, ipad). Once measurement is over, the LCD of device displays results. And the device will start to transmit data to the pair-up BT terminal automatically. Thus users can display, manage and storage measurement data more easily.
The requested information is related to an automated non-invasive sphygmomanometer (blood pressure monitor), not an AI device. Therefore, some of the questions, particularly those related to experts, ground truth methods for AI, MRMC studies, and separate training/test sets for AI, are not directly applicable.
However, I can extract the information relevant to the clinical validation of this medical device, which is typically a performance study comparing the device's measurements against a reference standard.
Here's the breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The clinical validation was performed against the standard AAMI/ANSI/ISO 81060-2:2013, which specifies acceptance criteria for automated non-invasive sphygmomanometers. While the document states that the device "meet the requirements of AAMI/ANSVISO 81060-2:2013," it does not explicitly list the numerical acceptance criteria or the specific reported device performance values (e.g., mean difference and standard deviation of blood pressure measurements).
Table of Acceptance Criteria and Reported Device Performance:
| Criterion | Acceptance Criteria (Specified by AAMI/ANSI/ISO 81060-2:2013) | Reported Device Performance (TMB-1591-A, RPM-BP100SBP, H-BP100SBP) |
|---|---|---|
| Mean Difference between Device and Reference (Systolic BP) | (Not explicitly stated in document, but standard specifies limits, typically within ±5 mmHg) | Device meets requirements of AAMI/ANSI/ISO 81060-2:2013 |
| Standard Deviation of Differences (Systolic BP) | (Not explicitly stated in document, but standard specifies limits, typically ≤ 8 mmHg) | Device meets requirements of AAMI/ANSI/ISO 81060-2:2013 |
| Mean Difference between Device and Reference (Diastolic BP) | (Not explicitly stated in document, but standard specifies limits, typically within ±5 mmHg) | Device meets requirements of AAMI/ANSI/ISO 81060-2:2013 |
| Standard Deviation of Differences (Diastolic BP) | (Not explicitly stated in document, but standard specifies limits, typically ≤ 8 mmHg) | Device meets requirements of AAMI/ANSI/ISO 81060-2:2013 |
Note: The document confirms compliance with the standard but omits the specific numerical results. To get the exact acceptance criteria and the device's measured performance (mean differences, standard deviations), one would need to consult the AAMI/ANSI/ISO 81060-2:2013 standard itself and the detailed clinical validation report, which is not provided here.
Study Information (Clinical Validation)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The AAMI/ANSI/ISO 81060-2:2013 standard typically requires a minimum of 85 subjects for clinical validation.
- Data Provenance: Not explicitly stated. Clinical studies are generally prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For blood pressure monitors, the "ground truth" is typically established by trained human observers using a reference sphygmomanometer (e.g., mercurial or auscultatory method) alongside the device under test. This usually involves multiple observers.
- Number of Experts: Not explicitly stated, but the AAMI/ANSI/ISO 81060-2:2013 standard usually mandates at least two trained observers.
- Qualifications: Not explicitly stated. The standard requires observers to be clinically trained and experienced in auscultatory blood pressure measurement. (e.g., physicians, nurses, or trained technicians).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For blood pressure validation, adjudication typically involves averaging readings between multiple observers or using a third observer in cases of significant discrepancy, as per the AAMI/ANSI/ISO 81060-2:2013 protocol.
- Adjudication Method: Not explicitly stated in the document, but the AAMI/ANSI/ISO 81060-2:2013 standard outlines a specific protocol for how observer readings are to be collected and compared to obtain the reference blood pressure.
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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:
- Not Applicable. This is a blood pressure monitor, not an AI device. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "standalone" performance in this context refers to the device's ability to accurately measure blood pressure on its own, which is what the clinical validation (AAMI/ANSI/ISO 81060-2:2013) assesses against a human-obtained reference. This study evaluates the device's performance without a human interpreting its output in the same way an AI output would be interpreted.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Reference Measurement: The ground truth for a non-invasive sphygmomanometer is established by simultaneous or carefully timed measurements by trained human observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or validated aneroid device).
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The sample size for the training set:
- Not Applicable. As this is not an AI device, there isn't a "training set" in the machine learning sense. The device's calibration and internal algorithms are developed during its engineering phase, which is distinct from a clinical validation study used for regulatory approval.
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How the ground truth for the training set was established:
- Not Applicable. See point 7. The device's internal algorithms are based on established oscillometric principles and refined through engineering and calibration processes, not a "training set" with ground truth in the AI context.
§ 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).