(274 days)
The Welch Allyn ProBP 2000 Digital blood pressure device is intended for use in measuring blood pressure and heart rate in patients at least 3 years of age or older with arm circumferences between 15 cm to 55 cm (approximately 5.9 to 21.7 inches).
The Welch Allyn ProBP 2000 automatically measures systolic and diastolic pressure and pulse rate. The device is intended to be used by clinicians and medically qualified personnel.
Contraindications:
This device is not intended for use on neonates, infants, or children under the age of 3 years. The effectiveness of this device has not been established in pregnant, including pre-eclamptic, patients.
The device 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 arm.
This device is designed for professional use, in other words, it is a professional BP device that only for trained users such as nurses, clinicians, and medically qualified personnel.
The measurement method for determining the systolic and diastolic pressure is similar with 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. This well-known technique for measuring blood pressure is called the "Oscillometric method".
The device includes the main unit and cuff unit. The main unit consists of the microprocessor, the pressure sensor, the operation key, the pump, the electromagnetic deflation control valve and the LCD. ABS is the plastic used in the outer housing. The device comes with one standard Reusable-11 Welch Allyn FlexiPort cuff. Other size cuffs can be ordered as needed for arm circumferences ranging from 15cm to 55cm. This device is equipped with the same wireless radio (Bluetooth) as supplied with the predicate device cleared in K161886, TMB-1591-A.
The subject device does not incorporate any software to support the BT wirelessly transmit function. In other word, ProBP 2000 has BT module but disabled the Bluetooth functionality. And Welch Allyn does not provide an application to receive data utilizing BT
The subject device does not have any externally-facing electronic interfaces.
Here's a summary of the acceptance criteria and study information for the Welch Allyn ProBP 2000 Digital Blood Pressure Device, based on the provided text:
Acceptance Criteria and Reported Device Performance
The device's accuracy was validated according to ISO 81060-2:2013, which specifies acceptance criteria for automated non-invasive sphygmomanometers. The core requirement is that "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013."
While the exact numerical limits of the ISO standard are not explicitly stated in the document, the report confirms that the device met these requirements.
| Acceptance Criteria (Based on ISO 81060-2:2013) | Reported Device Performance |
|---|---|
| Mean error and standard deviation of differences for systolic blood pressure not exceeding specified limits. | Met: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013" |
| Mean error and standard deviation of differences for diastolic blood pressure not exceeding specified limits. | Met: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2:2013" |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 88 qualified healthy subjects.
- Subject Demographics:
- Age: 3-12 years (35 pediatric) & 12-75 years (53 adults / adolescents)
- Gender: 39 males & 49 females
- Racial/Ethnic Background: Any
- Data Provenance: The document does not explicitly state the country of origin where the clinical validation study was conducted, nor does it specify if the data was retrospective or prospective. Given it's a clinical validation study for a new device, it is highly likely to be a prospective study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts or their qualifications for establishing ground truth, as is typical for blood pressure device clinical validation studies. ISO 81060-2 usually involves simultaneous measurements by trained observers using a mercury sphygmomanometer as the reference standard, rather than a panel of "experts" in the sense of image review or diagnostic interpretation. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe a specific adjudication method. For blood pressure device validation, the standard approach involves two or more trained observers performing simultaneous auscultatory measurements alongside the automated device, with discrepancies resolved according to the standard's protocol (e.g., if a certain difference is exceeded, a third observer might be involved, or the measurement discarded). -
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:
No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure measurement device and does not involve AI assistance for human readers/clinicians in diagnostic interpretation. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the clinical validation described is a standalone performance study. The device's algorithm measures blood pressure and heart rate without human interpretation being part of the measurement process itself. The study compared the device's readings directly to a reference standard (auscultatory measurement) to assess its accuracy. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established through a reference standard method, which, for blood pressure devices, typically involves simultaneous auscultatory measurements performed by trained observers using a reference sphygmomanometer (e.g., mercury sphygmomanometer), as per the requirements of ISO 81060-2. -
The sample size for the training set:
The document does not explicitly state the sample size for the training set. It mentions the device uses an "oscillometric algorithm" and that the algorithm's accuracy "has been validated through bench testing including testing to the blood pressure standard, IEC 80601-2-30." It also states, "The oscillometric algorithm in the device measures pulse heights at various cuff pressures throughout the cycle. Those pulse heights are used to build a patient specific pulse envelope as taught by standard oscillometric technique." This suggests general physiological principles and established oscillometric techniques are used, rather than a specific algorithm trained on a large, labeled dataset in the way a modern AI algorithm might be. -
How the ground truth for the training set was established:
As there is no explicit mention of a training set in the context of a machine learning model, the concept of "ground truth for the training set" as it applies to AI algorithms doesn't directly apply here. The algorithm is based on well-established oscillometric principles for blood pressure measurement rather than being "trained" on a specific dataset in the modern AI sense. The development of such algorithms typically involves engineering and physiological understanding, and refinement through extensive testing (including bench and clinical testing as mentioned) against reference methods.
§ 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).