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The BestShape system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings. The measurement position of the device is the wrist of the subject. This system should be used for the testing on people over age of 18.

The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns

The BestShape Blood Pressure Monitoring System uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with an inflatable wrist cuff on adults.

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

Device: BestShape Blood Pressure Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for the test set used in the performance studies or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the system "was validated by the tests according to IEC80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009." These standards typically outline requirements for clinical validation, including population demographics and sample sizes, but the specific details for this device's study are not provided in this summary.

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

The document does not provide any information regarding the number of experts or their qualifications used to establish ground truth for the test set. For blood pressure devices, ground truth is usually established through simultaneous measurements by a trained clinician using a calibrated sphygmomanometer, but this information is not explicitly stated.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or is not reported in this document. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.

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

Yes, a standalone performance assessment was done. The entire premise of the submission is to demonstrate the safety and effectiveness of the device (BestShape Blood Pressure Monitoring System) itself, which operates autonomously to measure blood pressure. The performance studies detailed (adherence to IEC80601-2-30:2009 and ANSI/AAMI/ISO 81060-2:2009) are focused on the accuracy and reliability of the device's measurements.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for blood pressure monitoring devices, the ground truth for validation against standards like IEC80601-2-30 and ANSI/AAMI/ISO 81060-2 is typically established through:

• Simultaneous auscultatory measurements by trained observers using a calibrated mercury or aneroid sphygmomanometer, or
• Invasive arterial pressure measurements in specific clinical scenarios (though less common for routine validation of consumer devices).

Given the context, it's highly probable that the ground truth was established by expert clinicians making simultaneous auscultatory measurements.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of information is typically relevant for machine learning algorithms that require a distinct training phase. While the device utilizes an "oscillometric method within the software algorithm," the summary focuses on validation against established performance standards rather than detailing the internal development process of the algorithm's training.

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

Since information about a specific "training set" is not provided, the document does not describe how its ground truth was established.

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