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The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.

The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a foam inner liner bonded to a tricot lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress Reprocessed DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The reprocessed devices are cleaned, inspected and tested, packaged and exposed to Ethylene Oxide (EO) gas wash. The VasoPress Reprocessed DVT Garments are provided non-sterile.

The provided text describes the regulatory clearance for the VasoPress Reprocessed DVT Garment. This submission is for the reprocessing of an existing device, not the development of a new AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, ground truth establishment for AI training/test sets, expert adjudication, etc.) are not applicable to this document.

The acceptance criteria and performance testing described relate to the physical and functional integrity of the reprocessed medical device compared to new, unused garments, to demonstrate substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" where the information is absent or irrelevant to a physical reprocessing claim.

Acceptance Criteria and Device Performance for VasoPress Reprocessed DVT Garment

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The text does not specify the exact sample sizes for each performance test (e.g., number of garments subjected to fatiguing, leak tests, etc.). It only states that "several performance tests were implemented" and "100% verification of bladder integrity is performed on reprocessed VasoPress garments."

• Sample Size: Not explicitly stated for all tests, but "100% verification" implies a large sample for leak testing for every reprocessed garment.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal performance validations by the manufacturer, Compression Therapy Concepts, Inc., located in Eatontown, NJ, USA.
• Retrospective or Prospective: Not explicitly stated, but typical of internal validation studies conducted before submission for regulatory approval.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a performance validation for a medical device's physical and functional properties after reprocessing, not an AI/ML diagnostic device requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not Applicable. This relates to human expert review for diagnostic classifications, not physical device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Not Applicable. This is a study type for evaluating the impact of an AI system on human reader performance, which is irrelevant for the physical performance validation of a reprocessed DVT garment.

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

Not Applicable. This term usually applies to AI algorithms. The "standalone performance" here would be the physical testing of the garment itself, which was indeed done. The tests mentioned (fatiguing, leak, inflation/deflation, Velcro) are exactly the standalone, algorithm-only type of tests for a physical device.

7. The Type of Ground Truth Used

The ground truth for this submission is the functional and material equivalence to new, unused VasoPress DVT Garments. The performance of new garments serves as the benchmark against which the reprocessed garments are compared.

8. The Sample Size for the Training Set

Not Applicable. The concept of a "training set" is relevant for machine learning models. This submission is for a reprocessed medical device. The data used to establish the reprocessing parameters might be considered analogous to a training set in a broad sense, but the specific number is not provided. The performance testing is analogous to a "test set" for the reprocessed garments.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As above, the concept of ground truth for a "training set" is not directly applicable to this type of device. The "ground truth" for developing the reprocessing method would have been based on established engineering principles, material science, and regulatory standards (like AAMI TIR30 for cleaning) to ensure the reprocessed device performs like a new one.

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The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

VasoPress DVT Supreme Mini, Pump Model No. VP500DM

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is a 510(k) premarket notification letter from the FDA to Compression Therapy Concepts regarding the VasoPress DVT Supreme Mini pump. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices for the indication of lowering the risk of deep vein thrombosis (DVT). It also outlines regulatory requirements but does not include any performance study details.

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The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

VasoPress DVT System, Pump Model VP500D

The provided document is a 510(k) premarket notification letter from the FDA for a medical device (VasoPress DVT System, Pump Model VP500D) that is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed information about acceptance criteria and specific study results proving the device meets those criteria.

The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but does not raise different questions of safety and effectiveness.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

Information that can be extracted or inferred:

• Device Name: VasoPress DVT System, Pump Model VP500D
• Intended Use/Indications for Use: "The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk."
• Regulatory Class: Class II (two)
• Product Code: JOW
• Regulation Number/Name: 21 CFR 870.5800 / Compressible Limb Sleeve
• Type of Approval: Substantial Equivalence via 510(k) premarket notification. This implies that the device's performance was compared to a predicate device's performance, but the details of that comparison are not included here.
• Standalone Performance: Since it's a pneumatic compression pump, its performance would inherently be "standalone" in the sense that it operates mechanically without human-in-the-loop interpretation like an AI diagnostic tool.

Information that CANNOT be extracted from this document:

• Table of acceptance criteria and reported device performance: This document does not specify quantitative acceptance criteria or detailed performance metrics.
• Sample sizes used for the test set and data provenance: No test studies or their associated data are described.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical studies with ground truth establishment are discussed.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical medical device, not an interpretative AI system.
• The type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as this is not an AI/machine learning device that involves a training set.
• How the ground truth for the training set was established: Not applicable.

Summary Table of Available Information (based on the limits of the provided document):

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The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Not Found

The provided text is an FDA 510(k) clearance letter for the VasoQuential Model VQ530, a compressible limb sleeve designed to increase venous blood flow and prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

It states that the device has been found substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about the acceptance criteria, specific studies, sample sizes, expert qualifications, or ground truth establishment that would be required to answer your detailed questions.

Regulatory clearance letters typically confirm that a device meets the substantial equivalence criteria based on information submitted in a 510(k) premarket notification. The detailed performance data, acceptance criteria, and study designs are part of the submission itself, not usually included in the clearance letter.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) premarket notification document or related performance study reports for the VasoQuential Model VQ530.

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