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The VasoGrad DVT Compression Garment is an external pneumatic compression device for use with VasoPress DVT Pumps, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

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The provided text is a 510(k) summary for a medical device (VasoGrad DVT Garment, Model-VG530). This type of document primarily focuses on regulatory clearance by demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria, performance metrics, and specific ground truth methodologies in the way a clinical trial report or a performance study would.

Therefore, the requested information elements related to detailed study design and acceptance criteria for demonstrating device performance (like specific accuracy metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not present in this document.

However, I can extract the following relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify formal "acceptance criteria" with quantitative targets (e.g., sensitivity > X%, specificity > Y%) or device performance metrics against such criteria. The FDA review determined that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is the primary "acceptance criterion" met for 510(k) clearance.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The 510(k) process typically relies on demonstrating equivalence through design, materials, and intended use, often supported by bench testing and sometimes limited clinical data, but not necessarily a large-scale, independent test set similar to diagnostic AI studies.

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

• Number of Experts: Not applicable/not specified.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/not specified.

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

• MRMC Study: Not applicable. This device is a physical, external pneumatic compression device, not an AI-assisted diagnostic tool.

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

• Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not applicable in the context of device performance in a diagnostic sense. The "ground truth" for the 510(k) clearance is that the device's design, materials, and intended effect are substantially equivalent to a predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning sense.

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

• Ground Truth Establishment for Training Set: Not applicable. This device does not involve a machine learning training set.

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