(17 days)
The Microlife Wrist Watch Blood Pressure Monitor, Model BP 3MK1-3 (BP W100) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3(BP W100) is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive 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 pulse rate, which is a well - known technique in the market called the "oscillometric method".
The device detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol " irregular heart beat signal has been detected.
Here's a summary of the acceptance criteria and study information for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100), based on the provided text:
Acceptance Criteria and Device Performance:
The document explicitly states that the device's performance is compared to its predicate device (BP3BU1) and other models (BP3BT0-AP) based on non-clinical and clinical testing. Crucially, the application for this model (BP3MK1-3) argues that no new clinical testing is required because the measurement algorithm and program codes are unchanged from the predicate device and the fundamental scientific technology is the same. Therefore, the device meets the acceptance criteria by being demonstrated as equivalent to an already cleared device that met the ANSI/AAMI SP10-2002 standard.
| Acceptance Criteria (Met by Predicate Device) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10-2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" (All relevant sections addressed and tested for predicate) | Clinical performance remains unchanged from predicate device BP3BU1. (No new clinical data presented for this specific device model due to equivalence claim). |
| Electrical, Mechanical, and Environmental Performance Requirements (FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions") | Device (BP3MK1-3) met all relevant requirements of: Reliability Tests (Storage, Operating, Vibration, Drop, Life) and EMC Test. |
| Equivalence to Predicate Device (BP3BU1) in terms of safety and effectiveness | Demonstrated no difference between BP3MK1-3 and BP3BU1 based on non-clinical test results. |
Study Details:
Since the submission claims substantial equivalence to a predicate device (BP3BU1) and states that "anther clinical test for the modified device, BP3MK1-3(BP W100) is not required" due to unchanged algorithms and technology, the following details pertain to the implication of that claim rather than direct studies for this specific device model. The document does not provide details of the original clinical study for the predicate device BP3BU1 beyond mentioning compliance with ANSI/AAMI SP10-2002.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either non-clinical (reliability, EMC) or clinical (from predicate) tests.
- Data Provenance: Not specified for the predicate device's clinical testing. The non-clinical tests (reliability, EMC) for the BP3MK1-3 were conducted by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided for the predicate device's clinical testing, nor is it relevant for the non-clinical tests conducted for the BP3MK1-3.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided for the predicate device's clinical testing.
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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-assisted diagnostic imaging device for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The core functionality of the device is to measure blood pressure using an oscillometric method, which is an algorithm-only measurement. The document states the "measurement algorithm and the program codes of the BP3MK1-3(BP W100) remain unchanged." This implies standalone performance was measured for the predicate and is assumed for this device. Specific performance metrics (accuracy, precision) are not detailed but are implied to meet the ANSI/AAMI SP10-2002 standard.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood pressure monitors seeking compliance with standards like ANSI/AAMI SP10, the "ground truth" typically involves simultaneous measurements by trained observers using a mercury sphygmomanometer (auscultatory method), often double-blinded, which serves as the "reference method." This would have been the case for the predicate device's clinical testing.
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The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that uses a "training set" in the conventional sense. The "training" of the device refers to its design and calibration based on known physiological principles and validated algorithms.
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How the ground truth for the training set was established:
- Not applicable (see point 7).
§ 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).