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ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

The ABPMpro is a portable device for recording physiological signals. The ABPMpro is used as a long-term blood pressure as well as a long-term ECG device. The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder. The ABPMpro consists of the following hardware: ABPMpro recorder with integrated accelerometer and position sensor; Brachial blood pressure cuff (3 sizes available); Optional: 3-channel ECG sensor; Optional: Plethysmogram-sensor (LED). Following the completion of the patient recording session, the device, cuff and electrodes are removed from the patient. The ABPMPro is connected to the PC using the USB cable. With the downloaded ABPMpro Analyzer Software open on the PC, the user can download the recorded data. The user can select the patient data and begin analysis. The device is intended for prescription use.

The provided text details the 510(k) premarket notification for the SOMNOmedics GmbH ABPMpro device. It outlines the device's intended use and presents a summary of performance testing and substantial equivalence comparison to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets alongside the device's performance. Instead, it states that performance testing was conducted to confirm "compliance to device specifications" and that recorded signals "comply with the performance criteria set forth by SOMNOmedics that includes the minimum performance specification recommended by the applicable standards."

The key standards referenced for performance are:

• IEC 80601-2-30: for automated non-invasive sphygmomanometers (blood pressure).
• IEC 60601-2-47: for ambulatory electrocardiographic systems (ECG).

The reported device performance based on the clinical study related to blood pressure measurement against a recognized standard (ISO 81060-2:2018) is the most direct evidence provided for meeting performance criteria:

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

The clinical testing data provenance is described as an "open, prospective, clinical validation study."

• General validation study (for blood pressure at rest): N = 90
  • Age: 12-76 years (Mean age 39.7 ± 15.1)
  • Gender: 47 male (52%), 43 female (48%)
• Ambulatory validation study (for blood pressure under dynamic exercise): N = 36
  • Age: 22-65 years (Mean age 40.9 ± 11.0)
  • Gender: 20 male (56%), 16 female (44%)

The country of origin for the data is not explicitly stated, but the sponsor is "SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236", which suggests the study may have been conducted in Germany or a location adhering to European standards. The study received "Ethics Committee approval" and was conducted "in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1)," which are US regulations. This suggests a study potentially designed for US regulatory submission, but the exact location is not provided.

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

For the blood pressure measurements, the ground truth was established by:

• Two observers provided simultaneous auscultatory reference BP measurements using a dual-head teaching stethoscope.
• Qualifications of experts: Not explicitly stated beyond "two observers." It's implied they are trained to accurately use the reference sphygmomanometer and stethoscope for auscultatory measurements.

4. Adjudication method for the test set

The method for establishing reference blood pressure was the "same arm sequential method" described in the Universal Standard (ISO 81060-2:2018). The involvement of "two observers" taking "simultaneous auscultatory reference BP measurements" suggests a form of consensus or comparison between them to establish the reference, as per the standard's requirements for validating automated sphygmomanometers. However, a specific adjudication method (e.g., 2+1, 3+1, averaging, arbitration) for discrepancies between the two observers is not explicitly described. The standard itself outlines how such measurements are to be handled.

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

No MRMC comparative effectiveness study was mentioned. The device, ABPMpro, does not appear to be an AI-assisted diagnostic tool; rather, it is a data acquisition and display device. The software "does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis." Therefore, a human-in-the-loop or AI assistance study involving human readers would not be applicable or expected for this device's stated function.

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

The primary performance evaluation for the blood pressure measurement was the "accuracy" against the reference standard (ISO 81060-2:2018), which is a standalone performance assessment of the device's ability to accurately measure BP. For ECG, the compliance to IEC 60601-2-47 further indicates a standalone performance assessment of its signal acquisition capabilities.

7. The type of ground truth used

The ground truth for blood pressure measurements was established using:

• Expert Consensus/Reference Measurement: Simultaneous auscultatory reference BP measurements taken by two trained observers (using a calibrated standard aneroid sphygmomanometer and a dual-head teaching stethoscope). This aligns with the "expert consensus" category for reference standard measurements in clinical studies of measurement devices.
• Standardized Method: The "same arm sequential method" described in the ISO 81060-2:2018 Universal Standard.

8. The sample size for the training set

The document does not specify a training set or its sample size. This is typical for medical devices that are not "machine learning/AI" devices requiring a distinct training and test split for an algorithm. The "ABPMpro" is presented as a measurement and recording device, not one with a diagnostic AI algorithm that learns from data.

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

As no training set is mentioned (see point 8), this information is not applicable.

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