Search Results

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.

Ask a specific question about this device