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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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