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The Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

The ANGIO-PRESS LITE DVT Compression Device is a non-invasive intermittent pneumatic compression system that aids in prevention and reduction in incidence of deep vein thrombosis (DVT). The system consists of a pump and soft pliable compression single patient use garments for leg or foot compression. The pump supplies compression on a pre-set inflation pressure of 40mmHg for calf and thigh compression, and 80mmHg for foot compression. Pressure in the garments is transferred to the extremities, augmenting venous blood flow, thus reducing stasis.

The provided text is a 510(k) Summary for a medical device called "ANGIO-PRESS LITE DVT Compression Device." This document details the application for marketing clearance based on substantial equivalence to a predicate device.

It's crucial to understand that this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy testing. Instead, it describes non-clinical testing to demonstrate that the device, a physical medical apparatus, meets pre-defined acceptance criteria for its physical and functional performance, ensuring its safety and effectiveness compared to a previously cleared device.

Therefore, many of the requested elements pertaining to AI/ML model validation (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable to this type of medical device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All the test results demonstrate ANGIO-PRESS LITE DVT Compression Device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device."

However, it does not provide a specific table of acceptance criteria with corresponding performance values for each non-clinical test. It lists the types of non-clinical tests conducted:

Note: The document explicitly states: "Differences between the devices cited in this section do not raise any new issue of substantial equivalence." and "the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device."

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

This is not applicable in the context of an AI/ML algorithm's test set. The non-clinical tests relate to the physical device's performance, durability, and safety. There is no "test set" of patient data in the sense of an algorithm's evaluation.

Data provenance: Not applicable in this context. The testing would have been done by or on behalf of the manufacturer, Pegasus Medical Supply, Inc. in Taiwan.

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

This is not applicable as there is no "ground truth" to establish for a physical DVT compression device's performance in the same way there would be for an AI diagnostic algorithm. The acceptance criteria for the physical tests are based on engineering specifications, regulatory standards, and comparison to the predicate device's established performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling or diagnoses for AI training/test sets.

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 is not applicable. This device is a physical DVT compression device, not an AI/ML diagnostic or assistive tool for human readers.

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

This is not applicable. This device is not an algorithm. Its performance is inherent in its mechanical operation.

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

For the non-clinical tests mentioned, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., electrical safety, biocompatibility standards), and the established performance parameters of the predicate device. For example, for pressure or flow rate, the "ground truth" is a measured value against a pre-defined range or target.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

In summary: The provided document is a 510(k) Summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing. The questions posed are primarily relevant for AI/ML-based medical devices or diagnostic tools, which is why most are not applicable to the "ANGIO-PRESS LITE DVT Compression Device." The "acceptance criteria" here refer to satisfying engineering specifications and regulatory safety standards, validated through a series of defined physical and electrical tests.

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