(112 days)
The Microlife Upper Arm Automatic Dizital Blood Pressure Monitor. Model BP3MW1-4B is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults on the upper arm at home.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW 1-4B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive 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, which is a well - known technique in the market called the "oscillometric method". This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The device detects the appearance of irreqular heartbeat during measurement. and the symbol " memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The provided text is a 510(k) Summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B. It primarily describes how the new device is substantially equivalent to previously cleared predicate devices. While it mentions clinical validation and standards, it explicitly states that new clinical testing for the subject device was not performed because it is technically identical to a predicate device regarding the measurement algorithm and program codes. Therefore, the details requested about acceptance criteria and a new study done to prove the device meets these criteria are largely absent for this specific device model.
However, I can extract information related to the predicate device's clinical validation as that is what the new device is inheriting its performance claims from.
Here's a breakdown of the available information based on your requested points:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance for the specific device in question (BP3MW1-4B). It states that the device's performance is identical to its predicate device, BP3MW1-4X(R), due to identical technical specifications, measurement algorithm, and program codes.
Therefore, the acceptance criteria and performance would be those established for the predicate device, which would have been validated against standards such as ANSI/AAMI IEC81060-2: "Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type." This standard sets criteria for accuracy in blood pressure measurements.
Based on the reference to ANSI/AAMI IEC81060-2 in the text, typical acceptance criteria for blood pressure monitors would involve:
- Mean Difference (Bias): The average difference between the device's readings and reference measurements (e.g., auscultatory readings).
- Standard Deviation (Precision): The variability of the device's readings compared to reference measurements.
- Number of readings within certain absolute differences: For example, how many readings are within ±5 mmHg, ±10 mmHg, etc.
As the document explicitly states "Repeat clinical testing in accordance with the standard ANSI/AAMI IEC81060-2 for the subject device BP3MW1-4B is therefore not necessary," it does not provide a new table of acceptance criteria and reported performance for this specific model.
Study Information (Inherited from Predicate Device)
Given that the clinical performance is inherited from the predicate device BP3MW1-4X(R), the following points relate to the type of study that would have been performed for that predicate device to meet the ANSI/AAMI IEC81060-2 standard, which is referenced. The document for K153077 does not provide the specific details for that predicate device's study.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this 510(k) summary for the predicate device's clinical validation. The ANSI/AAMI IEC81060-2 standard typically requires a minimum of 85 participants for clinical validation.
- Data Provenance: Not specified. Clinical validation studies for such devices are typically prospective, conducted in a clinical setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. For blood pressure monitor validation studies (e.g., against ANSI/AAMI IEC81060-2), at least two trained observers (e.g., physicians or nurses) are typically used for reference auscultatory measurements.
- Qualifications: "Trained observers" who are specifically skilled in auscultatory blood pressure measurement.
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Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. In blood pressure validation studies using multiple observers, differences between the observers' readings are typically handled by averaging the readings if they are within a specified tolerance, or by discarding the measurement if they are outside a tolerance, or by having a third observer adjudicate.
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If a multi reader multi case (MRMC) comparative effectiveness study was done:
- MRMC Study: No. This type of study (MRMC) is generally for diagnostic imaging devices assessing reader performance. Blood pressure monitor validation primarily focuses on the device's accuracy in comparison to a reference standard, not on human reader improvement with AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the clinical validation is a standalone performance assessment of the oscillometric algorithm against the auscultatory reference. The "algorithm only" aspect is inherent in the device's automated function.
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The type of ground truth used:
- Ground Truth: Expert consensus auscultatory readings obtained concurrently by trained observers using a mercury sphygmomanometer or validated equivalent are the standard ground truth for blood pressure monitor validation according to ANSI/AAMI IEC81060-2.
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The sample size for the training set:
- Training Set Sample Size: Not specified. Blood pressure monitor algorithms are typically developed using internal datasets, and the clinical validation (as discussed above) is usually a separate external validation.
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How the ground truth for the training set was established:
- Training Set Ground Truth: Not specified in this document. During algorithm development, it would likely involve carefully measured blood pressure data (potentially also using auscultatory reference) from a diverse population to train and optimize the oscillometric algorithm.
§ 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).