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The BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses auscultatoric and oscillometric signals to measure the blood pressure of human beings, or uses purely the oscillometric signals. Systolic, mean arterial pressure and the heart rate are measured. The BR-102 plus is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48h). The BR-102 plus can be used for patients of both sexes and all races.

The BR-102 plus should not be used with neonates.

The BR-102 plus is a portable, compact, lightweight, microprocessor based ambulatory blood pressure monitor. Two versions are available:

• Using auscultatoric and oscillometric signals. During cuff delfation auscultatoric and . oscillometric signals are analysed by the microprocessor to determine the blood pressure, where the oscillometric measurement is used as a backup.
• Purely oscillometric method to use the device without a microphone. The oscillometric . signals are analysed by the microprocessor to determine the blood pressure.

The device is worn or carried by the patient. The cuff is borne on the upper arm. An electrical pump inside the device generates the pressure in the cuff. The BR-102 plus is powered from two AA size recharchable NiMH batteries. The BR-102 plus initialises blood pressure measurements depending on a predetermined shedule (normally predetermined by a physician), or on demand (by using the start key). Each reading is stored in memory, allowing the physician to download all the results obtained during the study period after the study has concluded, to be analysed by the PC software. The readings are displayed on the display for a short time.

The associated MT-300 PC software provides the setup of the system. A measurement shedule can be defined with the MT-300 program and up-loaded into the BR-102 plus. All the settings can also be made on the device. After the ambulatory blood pressure study has been completed (up to 48h) the stored readings in the BR-102 plus are downloaded to the PC using the MT-300 program. The MT-300 programm provides the data in tabular and graphic form, as well as a patient report and statistical values.

Here's an analysis of the provided text to extract the requested information about the BR-102 plus NIBP Holter System's acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the BR-102 plus has "satisfactory passed all tests" according to specific standards but does not provide a table of numerical acceptance criteria or the reported device performance against those criteria. It refers to:

• Standards Met: ANSI/AAMI SP10, EN 60601-1, EN 60601-1-2, EN 60601-2-30, EN 1060-1, EN 1060-3.
• Clinical Test Protocol: "International Test Protocol for validation of blood pressure measuring devices in adults" of the European Society of Hypertension.
• Performance Claim: "The BR-102 plus has satisfactory passed all tests."

Without a direct table of acceptance criteria and performance from the document, I cannot create one as specifically requested. The document primarily asserts compliance with established standards. ANSI/AAMI SP10 and the ESH protocol contain specific accuracy requirements for blood pressure devices (e.g., mean difference and standard deviation between device and reference measurements), but these values are not explicitly stated in the provided text as the device's acceptable performance or actual performance.

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

The document does not explicitly state the sample size used for the clinical test set. It mentions the "International Test Protocol for validation of blood pressure measuring devices in adults" by the European Society of Hypertension, which typically specifies sample sizes (e.g., usually 33 subjects) for validation studies, but this specific detail is not present in the provided text regarding the BR-102 plus study.

The country of origin for the data is not explicitly stated in relation to the clinical tests, but the submitter (SCHILLER AG) is located in Switzerland. The study type (retrospective or prospective) is also not explicitly stated.

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

The document mentions that the BR-102 plus measurements are compared with "manual auscultatory measurements as described in the SP10." The SP10 standard itself outlines requirements for expert observers (e.g., two trained observers) for auscultatory reference measurements. However, the exact number of experts used for this specific study and their qualifications (e.g., radiologist with 10 years of experience) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The document states that the comparison is made against "manual auscultatory measurements as described in the SP10." The SP10 standard generally prescribes comparison to two trained observers with specific disagreement criteria for valid measurements. However, the specific adjudication method (e.g., 2+1, 3+1, none) used in the BR-102 plus study, beyond referencing the SP10 method, is not explicitly detailed in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this document. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone study was performed. The clinical tests involve comparing the device's measurements (algorithm only) to a reference standard (manual auscultation). The description of the device as a "microprocessor based ambulatory blood pressure monitor" that "determines the blood pressure" indicates its standalone function without human interpretation of raw signals for diagnosis.

7. The Type of Ground Truth Used

The ground truth used for comparison in the clinical tests was manual auscultatory measurements. This is explicitly stated: "To verify the overall system efficiency the measurments of BR-102 plus are compared with manual auscultatory measurements as discribed in the SP10."

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This type of device (a blood pressure monitor) based on established measurement principles (auscultation and oscillometry) typically would not have a "training set" in the sense of a machine learning algorithm that requires extensive labelled data for supervised learning. Its algorithms are usually pre-programmed based on physiological models and engineering principles, then validated against clinical standards.

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

As no training set is described or implied for this device in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided text. The device's functioning is based on physical measurement principles, not a data-driven training process in the AI sense.

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