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The Ambulatory Blood Pressure Monitor is capable of measuring systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are stored in the monitor and can be transferred to analysis system via wire or wireless transmission. It is intended for use as an aid or adjunct to diagnosis and treatment.

The SA Series ABPM (Ambulatory Blood Pressure Monitor), primarily composed of Ambulatory Blood Pressure Monitor (ABPM) and ABPM Analysis software (Smart ABPM View), is designed to measure systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time. The monitor inflates and deflates the cuff on the upper arm to measure blood pressures and pulse by the oscillometric method and stores the measurement. The stored measurements are transferred into analysis software installed in generally used PC via wire transfer or Bluetooth. The monitor is carried around by patients. Patients are requested to come back to medical treatment site after recording time. The systolic and diastolic blood pressures, and pulse data recorded in monitor will be transferred into PCs and then analyzed, displayed and edited by Analysis software.

The provided text describes the 510(k) premarket notification for the Edan Instruments, Inc. Ambulatory Blood Pressure Monitor (Models: SA-10, SA-05, SA-06, SA-08 and SA-09). The device measures systolic and diastolic blood pressure and pulse using the oscillometric method.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the international standard for non-invasive sphygmomanometers, ISO 81060-2.

Note: The document explicitly states that the "Blood Pressure results meet or exceed ANSI/AAMI/ISO 81060-2:2013 standards for non-invasive accuracy: ±5 mmHg mean error & 8 mmHg standard deviation" in the predicate comparison table, and later confirms compliance with the updated ISO 81060-2:2018+A1:2020 standard. For heart rate accuracy, the subject device's performance criterion is listed as "Heart Rate accurate within ±3 bpm or ±3.5%, whichever is greater," which is also the reported performance.

Study Information

Here's a breakdown of the study details based on the provided text:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document mentions "investigation with qualified subject distribution" for the clinical test but does not specify the exact sample size.
   • Data Provenance: The document implies the data is prospective, as it describes a "clinical investigation" undertaken specifically to validate the device. The country of origin of the data is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitors, ground truth typically involves simultaneous measurements by a trained professional using a reference standard (e.g., auscultation with a mercury sphygmomanometer) as part of the ISO 81060-2 standard protocol.

3. Adjudication method for the test set:

   • The document does not describe a specific adjudication method. For validation against ISO 81060-2, the comparison is typically direct against the reference standard.

4. 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:

   • No MRMC comparative effectiveness study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

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

   • Yes, a standalone performance study was done for the device. The "Clinical test" section states, "The subject devices have been undertaken clinical investigation in accordance with ISO 81060-2:2018+A1:2020 to validate the clinical safety and effectiveness within its intended use." This standard is for the performance of automated non-invasive sphygmomanometers themselves.

6. The type of ground truth used:

   • The ground truth would be established through simultaneous or closely timed measurements by a "reference standard" as defined by ISO 81060-2, typically involving trained observers using a mercury or other validated sphygmomanometer performing auscultatory measurements. This is inherent to the ISO 81060-2 clinical validation protocol.

7. The sample size for the training set:

   • The document does not mention a training set sample size. Ambulatory Blood Pressure Monitors typically use proprietary algorithms for oscillometric measurements, which are developed and validated during the product's R&D phase; however, details of an algorithm's training data are not usually part of a 510(k) summary for this type of device. The ISO 81060-2 study is a validation, not a training activity.

8. How the ground truth for the training set was established:

   • The document does not provide information about how ground truth was established for any training set, as it does not discuss a training set for the NIBP algorithm.

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TM-2440 and TM-2441 blood pressure monitors are designed to monitor systolic and diastolic pressure, and pulse rate of adults who are twelve (12) years and older by using the oscillometric method.

TM-2441 has four environmental functions to measure activity monitoring (3-axis accelerometer), ambient temperature monitoring, barometric pressure monitoring, and waveform capability. These functions are not observed by patients form the device display and can only be used by the medical professionals.

TM-2440 & TM-2441 Digital Blood Pressure Monitors have the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. The blood pressure measurement starts with the inflation process by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method during the deflation process. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. There is a maximum pressure safety setting at 299 mmHg. TM-2440 & TM-2441 Digital Blood Pressure Monitors will not inflate the cuff higher than 299 mmHg. TM-2440 & TM-2441 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the OLED and transmitted via Bluetooth wireless module to the connected app. The cuff is also deflated automatically to 0 mmHg at the same time. If the monitor receives no further action from the user for 1 minute, it will automatically turn off by itself and waiting for the next measurement timing.

We can break down this request based on the information provided in the given text.

The device in question is the A&D Medical TM-2440 & TM-2441 Digital Blood Pressure Monitors.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary performance acceptance criteria for the blood pressure monitors are based on the ISO 81060-2:2013 standard.

Note: The reported device performance is for both TM-2440 and TM-2441 models, as they passed "all blood pressure measurement accuracy requirements."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for the Test Set: Not explicitly stated in the provided text. The text only mentions "The summary of the test results of ISO 81061-2 is listed below," implying a clinical validation study was conducted as per the ISO standard, which has specific sample size requirements. While the standard is cited, the actual number of subjects is not provided in this summary.
• Data Provenance: Not explicitly stated. The study was conducted as part of the regulatory submission (510(k)) in the US, but the geographic origin of the participants or clinical sites (e.g., country of origin) is not mentioned. The study is assumed to be prospective as it's a clinical validation study for a new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated in the provided text. The ISO 81060-2:2013 standard for automated sphygmomanometers typically requires comparison of the device under test to auscultatory measurements obtained by trained observers (experts) using a mercury sphygmomanometer or validated reference device.
• Qualifications of Experts: Not explicitly stated. However, given the reliance on ISO 81060-2:2013, it is implied that the ground truth (reference blood pressure values) would have been established by qualified and trained personnel according to the standard's protocol for taking reference measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For clinical validation of blood pressure monitors, the ISO 81060-2:2013 standard outlines a specific protocol for taking "reference measurements" (ground truth). This typically involves simultaneous or closely timed measurements by multiple trained observers (e.g., two observers) to minimize measurement error and observer bias, often with a predefined method for resolving discrepancies (e.g., averaging or a third observer if differences exceed a threshold). However, the specific adjudication details are not present in this summary.

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

• MRMC Comparative Effectiveness Study: Not applicable. The device in question is a standalone digital blood pressure monitor, not an AI-powered diagnostic imaging tool or a system designed to assist human "readers" (e.g., radiologists). Therefore, this type of study is not relevant to this device.

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

• Standalone Performance Study: Yes, indirectly. The ISO 81060-2:2013 clinical BP measurement study evaluates the performance of the device itself (the "algorithm only," in a sense, as it's an automated measurement device) against a reference standard. The results presented in the table (Criterion 1 & 2) directly reflect the device's accuracy without human intervention in the measurement process (beyond applying the cuff and initiating the measurement). The device is designed to operate as a standalone automated blood pressure monitor.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus applying the methodology outlined in ISO 81060-2:2013. This standard details how reference blood pressure measurements (auscultatory readings from trained observers) are obtained and averaged to form the ground truth against which the automated device's readings are compared.

8. The Sample Size for the Training Set

• Sample Size for the Training Set: Not applicable / Not mentioned. This device is a measurement instrument, not typically an AI/machine learning model that undergoes a separate "training" phase with a distinct training dataset in the conventional sense. Its underlying algorithm for oscillometric blood pressure determination is based on established physiological principles and likely developed through engineering and calibration, rather than statistical machine learning training on a large dataset. The provided text does not mention any training set or machine learning components.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, the concept of a "training set" and associated "ground truth" establishment in a machine learning context does not appear to apply to this device based on the provided information.

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