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HL858CP automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.

The device can accurately measure in pregnant patients including those with known or suspected in preeclampsia condition.

HL858CP detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the user tracking their blood pressure level.

Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

HL858CP automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use. The device can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.

The device will display a symbol O-W- to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, when Triple Check mode is turned on by user, the symbol ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements.

HL858CP is equipped with Bluetooth Data Transmission function, which can electronic transfer the measured data of HL858CP to the paired Bluetooth-enabled device. The transferable measured data includes Systolic, Diastolic, and Pulse. The Bluetooth Data Transmission is without controlling or altering the functions or parameters of HL858CP and Paired Bluetooth-enabled device. In addition, the Bluetooth Data Transmission function could transfer the battery status of HL858CP to the Paired Bluetooth-enabled device without any controlling or altering on both devices.

Besides, Bluetooth Data Transmission function could provide Date/Time synchronization for HL858CP, which simply help users set Time/ Date information. It will help users prevent from entering incorrect time information.

The provided text describes the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP, and its clinical validation, particularly regarding its ability to accurately measure blood pressure in pregnant patients, including those with pre-eclampsia. This information is gleaned from various sections of the 510(k) Summary.

Here's a breakdown of the requested information:

Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical validation for non-invasive sphygmomanometers, including this device, is typically against the ISO 81060-2 standard. This standard sets specific criteria for accuracy.

Note: While the summary states that the criteria were fulfilled, the exact numerical performance values (mean difference and standard deviation) are not explicitly given in the provided text for either the general or pregnant populations. The summary focuses on meeting the standard.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: "90 subjects with qualified distribution."
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, for a clinical validation study for a medical device approval, especially an accuracy study like this, it is almost exclusively prospective and generally conducted in a controlled clinical environment (e.g., a hospital or clinic). The lack of country specification likely means it was conducted where the manufacturer is based or in a region with established clinical trial infrastructure that is recognized by the FDA (e.g., often US, Taiwan, Europe).

3. 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 or qualifications of experts used to establish the ground truth. For blood pressure measurement validation according to ISO 81060-2, the ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a validated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a rigorous protocol (e.g., auscultatory method with trained independent observers). The standard prescribes specific requirements for these observers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not explicitly describe an adjudication method for the test set. For ISO 81060-2 validation, the ground truth is typically captured by two independent observers (auscultatory method), and if there's a significant discrepancy, a third observer might be involved. The standard has specific requirements for the agreement between observers (e.g., differences within certain mmHg). While not explicitly stated as "adjudication," this method ensures robust ground truth.

5. 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

This device is a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The study described is a clinical validation of the device's measurement accuracy against a reference standard.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The entire clinical investigation described ("compliant to the standard of ISO 81060-2: Second Edition 2013-05-01") is a standalone algorithm (device) performance study. The device's measurements are directly compared to the clinically established ground truth, demonstrating the device's accuracy without requiring human interpretation or intervention in the measurement process beyond device operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used is based on clinically established reference measurements of blood pressure, typically using the auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device) performed by trained medical professionals, as per the ISO 81060-2 standard. This is most akin to an expert consensus method from trained individuals applying a gold standard technique.

8. The sample size for the training set

The document does not specify a training set sample size. This is common for traditional medical devices like blood pressure monitors, which are validated against standards like ISO 81060-2 based on their mechanical and algorithmic adherence to established measurement principles, rather than being "trained" like machine learning models. The 90 subjects mentioned are for the clinical validation/test set.

9. How the ground truth for the training set was established

As there is no "training set" in the context of machine learning for this device, a specific method for establishing ground truth for a training set is not applicable/not detailed. The device's internal algorithms for oscillometric blood pressure measurement are developed based on established physiological principles and engineering, not typically via a data-driven training process in the way AI models are.

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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.

• 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.

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