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The Zewa® MFM-007 Blood Pressure 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 upper arm.

The Zewa® MFM-007 Blood Pressure Monitor measures the systolic and diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the upper arm, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.

The provided text describes the Zewa MFM-007 Blood Pressure Monitor. However, it does not explicitly state acceptance criteria in a structured table or detail a specific study proving the device meets performance criteria beyond general statements about compliance with technical specifications.

Based on the provided information, here's what can be extracted and what is not available:

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

This information is not provided in the document. The text states:

• "The Zewa® MFM-007 Blood Pressure Monitor 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 general statement about compliance but does not list specific numerical acceptance criteria (e.g., accuracy ranges for systolic/diastolic pressure) or the measured performance results.

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

This information is not provided. The document makes no mention of a test set, patient data, sample size, or the provenance of any data (e.g., country of origin, retrospective/prospective).

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

This information is not provided. As there's no mention of a test set involving human evaluation or ground truth establishment, this detail is absent.

4. Adjudication method for the test set:

This information is not provided. Given the lack of a test set description, an adjudication method is not mentioned.

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:

This information is not provided. The device is an automated blood pressure monitor and does not involve human readers or AI assistance in a diagnostic context.

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

The device itself is a standalone, automated blood pressure monitor. The "device testing" mentioned refers to its intrinsic performance. However, there's no specific "standalone study" detailed in terms of methodology or results. The entire function of the device is algorithm-driven (measuring blood pressure automatically), so its general testing covers its "standalone performance."

7. The type of ground truth used:

This information is not explicitly stated in a way that aligns with typical "ground truth" for diagnostic devices (e.g., pathology, outcomes data). For a blood pressure monitor, the "ground truth" for accuracy would typically be simultaneous measurements from a highly accurate reference device (e.g., a mercury sphygmomanometer or an invasive arterial line). The document only states "compliance with numerous technical specifications," implying that the device's readings were compared against established standards for blood pressure measurement accuracy, but the specifics of how this ground truth was established are not detailed.

8. The sample size for the training set:

This information is not provided. The device does not appear to involve machine learning in a way that would typically require a "training set" of patient data in the modern sense. It's an automated medical device based on established oscillometric principles.

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

This information is not applicable/provided as there's no mention of a training set.

In summary, the provided 510(k) summary focuses on the device description, predicate device, and general statement of compliance with technical specifications, rather than a detailed clinical or performance study report with specific acceptance criteria and results.

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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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