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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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The Pegasus Medical Supply Inc. ANGIO-PRESS IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.

ANGIO-PRESS DVT Compression Device that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). ANGIO-PRESS DVT Compression Device is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants.

ANGIO-PRESS DVT Compression Device is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, ANGIO-PRESS DVT Compression Device is identified as a compressible limb sleeve.

This document describes the ANGIO-PRESS DVT Compression Device, Model IPCS, and its substantial equivalence to a predicate device. As such, the information provided is focused on regulatory compliance and comparison, rather than a clinical study with detailed performance metrics against acceptance criteria generally seen in machine learning or diagnostic device studies.

Therefore, many of the requested points related to advanced AI/ML device studies (e.g., sample sizes for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not directly applicable or available in this type of submission.

Here's an attempt to address the request based on the provided text, highlighting where information is not present:

Acceptance Criteria and Device Performance Study for ANGIO-PRESS DVT Compression Device

The ANGIO-PRESS DVT Compression Device's acceptance criteria and proven performance are primarily established through non-clinical safety and performance testing to recognized standards, demonstrating substantial equivalence to a legally marketed predicate device (VasoPress DVT Supreme Mini, Pump Model No. VP500DM, K101915).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a single table detailing specific numerical acceptance criteria (e.g., a specific pressure range) alongside reported numerical performance for each criterion. Instead, it refers to conformity with applied standards and general device specifications.

General Device Performance (Comparison to Predicate):

The acceptance criteria for each "Testing Item" (e.g., Biocompatibility, Software, EMC, Electrical Safety, Performance, Risk Management, Usability) were defined by the respective international standards and regulations listed. The "Reported Device Performance" for these items is universally stated as: "All the test results demonstrate ANGIO-PRESS DVT Compression Device meet the requirements of its pre-defined acceptance criteria and intended uses."

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

This is a physical medical device, not an AI/ML diagnostic system. The "test set" refers to physical units of the device and components subjected to engineering and safety testing. The document does not specify the exact sample size (number of devices/components tested) for each non-clinical test. The data provenance is from the manufacturer's internal testing or contracted testing laboratories, located in Taiwan (R.O.C.). The testing is prospective for the purpose of this submission.

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

Not applicable. For non-clinical device testing, "ground truth" is established by adherence to specified engineering standards, measurement protocols, and safety requirements. Expert judgment might be involved in test design or interpretation of results, but not in the sense of clinical "ground truth" for diagnostic accuracy.

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations in clinical studies or AI/ML evaluations. For non-clinical device testing, results are typically objective measurements against technical specifications and standard compliance.

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

Not applicable. This device is a DVT compression device, not an AI-assisted diagnostic or interpretive system. No human reader involvement or AI assistance is relevant here.

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

Not applicable. This is not an algorithm-only device.

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

For non-clinical testing, the "ground truth" is adherence to established international standards and regulations (e.g., ISO, IEC, USP standards for biocompatibility, electrical safety, software, performance, risk management, usability). Measurements and observations during testing are compared against these standards for compliance.

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. No machine learning training set exists for this device.

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