(100 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GY1-2N is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique in which an inflatable cuff is being wrapped around the upper arm.
The device is also validated for all adult diabetic users.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
The blood pressure monitor is a fully automatic digital blood presure measuring device for use by adults (also applicable for diabetic patients) on the upper arm at home or in your doctor's/nurse's office.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GY1-2N is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -42 cm by using a noninvasive 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 using a semiconductor 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 symbol " * " is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.
The device is also validated for all adult diabetic users.
The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults(also applicable to the diabetic patients) on the upper arm at home or in your doctor's/nurse's office.
Here's an analysis of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GY1-2N, based on the provided text:
Important Note: The provided document is a 510(k) summary for a new device (BP3GY1-2N) claiming substantial equivalence to a predicate device (BP3GX1-5X). Therefore, the "study that proves the device meets the acceptance criteria" refers to the predicate device's clinical validation study, which the subject device is leveraging. The new device itself did not undergo a separate clinical validation study for blood pressure accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for blood pressure monitors is typically defined by standards like ANSI/AAMI/IEC 81060-2. While the exact numerical criteria are not explicitly stated in this document (they would be detailed in the standard itself), it is generally understood to involve accuracy metrics for systolic and diastolic blood pressure measurements compared to a reference method.
The document indicates that the device's performance is demonstrated by its substantial equivalence to a clinically validated predicate device.
| Acceptance Criteria (from ANSI/AAMI/IEC 81060-2) | Reported Device Performance (via predicate) |
|---|---|
| Blood Pressure Accuracy: | Blood Pressure Accuracy: |
| Not explicitly detailed in the provided text, but generally involves: |
- Mean difference (device vs. reference) and standard deviation for systolic and diastolic BP
- Within-subject differences (e.g., % of readings within 5 mmHg) | The subject device (BP3GY1-2N) is technically identical to the primary predicate device (BP3GX1-5X, K183469) concerning detection algorithm and fundamental scientific technology. The predicate device was clinically validated according to ANSI/AAMI/IEC 81060-2 and proved accurate for blood pressure detection. Also validated for adult diabetic users. |
| Irregular Heartbeat Detection: | Detects and signals irregular heartbeat during measurement. |
| Functional / Safety Standards Compliance: | Complies with numerous IEC, ISO, and AAMI standards for electrical safety, EMC, risk management, biocompatibility, and home healthcare environments (listed in section 7). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in this document for the predicate device's clinical study. The document refers to the predicate's 510(k) (K183469) where this information would be found. Standards like ANSI/AAMI/IEC 81060-2 require specific sample sizes (e.g., at least 85 subjects).
- Data Provenance: Not specified in the provided text. The location of the original clinical validation study for the predicate device is not mentioned.
- Retrospective or Prospective: Not specified in the provided text for the predicate device's clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. For clinical validation of blood pressure devices based on standards like ANSI/AAMI/IEC 81060-2, multiple qualified observers (e.g., physicians or specially trained technicians) are typically used for the auscultatory reference measurements.
- Qualifications of Experts: Not explicitly stated in this document. However, standard clinical validation protocols require observers to be trained and certified in auscultatory blood pressure measurement.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. In auscultatory reference measurements, it is common to have multiple observers taking measurements simultaneously, and their readings are often averaged or assessed for agreement. The specific method would be detailed in the predicate device's clinical study report.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study for human readers with and without AI assistance was not conducted. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting cases.
- Effect size of human readers improved with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes. The clinical validation of the predicate device (BP3GX1-5X) against the ANSI/AAMI/IEC 81060-2 standard represents a standalone performance study. This standard assesses the accuracy of the automated device (algorithm only) compared to a reference standard (auscultation), without human interpretation of the device's output influencing the measurement itself. The subject device BP3GY1-2N is leveraging this standalone clinical data from the predicate.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for blood pressure accuracy in studies following ANSI/AAMI/IEC 81060-2 is established using auscultatory measurements performed by trained human observers using a stethoscope and manometer. This is considered the clinical reference standard for non-invasive blood pressure.
8. Sample Size for the Training Set
- Sample Size for Training Set: This information is not provided in the document. For a medical device like this, the "training set" typically refers to the data used to develop and refine the oscillometric algorithm. This data is usually proprietary to the manufacturer and not typically disclosed in 510(k) summaries unless specifically required for algorithm-based devices where the training data directly impacts performance claims.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: This information is not provided in the document. Similar to the sample size, the process for establishing ground truth for the internal development and training of the oscillometric algorithm is generally proprietary. It would likely involve similar auscultatory reference measurements to those used in the final clinical validation, but potentially in a more controlled or varied dataset for algorithm optimization.
§ 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).