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The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the wrist. The device is also intended to estimate body fat by bioelectrical impedance analysis.

The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor uses bioelectrical impedance analysis, a well established technique, for body fat assessment. It measures the systolic and diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the wrist, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.

The provided text describes a 510(k) summary for the Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor. It details the device's intended use and the general testing performed. However, it does not contain specific acceptance criteria, study details, or performance results in the format requested, nor does it include information about AI/ML models, training/test sets, expert ground truth, or MRMC studies.

The document states that the device was tested for "compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening." This is a high-level statement about general safety and performance testing, not detailed clinical performance or accuracy studies against acceptance criteria.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a response based on the available information:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor describes general device testing but does not detail specific acceptance criteria for accuracy (e.g., blood pressure measurement accuracy against a gold standard or body fat estimation accuracy) or present a study proving the device meets such criteria.

The document mentions that the device was "tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening." This indicates engineering and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified. (The document describes the device's general testing, not clinical study data provenance.)

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

• Not applicable/Not specified. The document does not describe a clinical study involving expert-established ground truth for the test set.

4. Adjudication method for the test set:

• Not applicable/Not specified. The document does not describe a clinical study or ground truth adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a standalone blood pressure and body fat monitor, not an AI-assisted diagnostic tool for human readers. No AI/ML component is mentioned.

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

• A standalone performance assessment was conducted for the device's technical specifications and general performance, as stated under "Device Testing." However, this does not refer to an algorithm in the context of AI/ML, but rather the device's overall functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not specified. The document refers to "technical specifications" as the basis for testing, implying engineering standards rather than clinical ground truth from expert consensus or pathology.

8. The sample size for the training set:

• Not applicable. The device described does not appear to involve a machine learning component requiring a training set. It uses "bioelectrical impedance analysis, a well established technique, for body fat assessment" and standard blood pressure measurement techniques.

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

• Not applicable. No training set is mentioned for this device.

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