(72 days)
The Microlife Upper Arm Blood Pressure Monitor, Model WatchBP Office (Twin200) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a noninvasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s).
The device can be used in connection with your personal computer (PC) running the WatchBP Office software .The memory data can be transferred to the PC by connecting the monitor with the PC via bluetooth.
Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Office (Twin200) is designed to measure systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an individual by using a non-invasive technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two electronic pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, pulse pressure (PP) and mean arterial pressure (MAP), which is a well - known technique in the market called the "oscillometric method".
The device has >, > and > measurement modes and has inflation pressure setting function, measurement intervals setting function etc. In additional, the device can be used in connection with your personal computer (PC) running the WatchBP Office software. The memory data can be transferred to the PC by connecting the monitor with the PC via bluetooth.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| AAMI/ANSI SP-10 standard clinical testing requirements | The device met all applicable requirements of the standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the AAMI/ANSI SP-10 clinical testing (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the testing was performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the AAMI/ANSI SP-10 clinical testing. This standard typically involves comparison against a reference method (often auscultatory measurements by trained observers), but specific details are not present.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For AAMI/ANSI SP-10, the "ground truth" standard is usually applied via a predefined protocol for comparison to the device's readings, rather than a separate adjudication process in the traditional sense of reaching consensus on diagnoses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the AAMI/ANSI SP-10 standard clinical testing is inherently a standalone performance study. It evaluates the accuracy of the automated device (algorithm only, without human-in-the-loop influence during the measurement process) against a reference standard.
7. The Type of Ground Truth Used
The ground truth used for the AAMI/ANSI SP-10 clinical testing would be a reference measurement, typically obtained via auscultatory methods by trained observers, as specified by the AAMI/ANSI SP-10 standard for validating automated blood pressure monitors. This is a form of expert-derived reference data.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" sample size. For a blood pressure monitor utilizing an "oscillometric method," the underlying algorithms are typically developed and validated over time using extensive physiological data, but the submission package primarily focuses on the clinical validation against a recognized standard (AAMI/ANSI SP-10) rather than the specific details of algorithm training data.
9. How the Ground Truth for the Training Set Was Established
Given that the document does not discuss a separate training set, it also doesn't detail how ground truth would have been established for it. The "oscillometric method" is a well-known technique, implying that its fundamental principles and calibration data are established through extensive physiological research and engineering practices, rather than a single, explicitly defined "training set" with ground truth in the context of this 510(k) summary.
§ 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).