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The Trinity Huntleigh Pump Compatible Sleeves is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.

Compressible Limb Sleeves

The provided text indicates that the device, Trinity Huntleigh Pump Compatible Sleeves, is substantially equivalent to a previously marketed predicate device (K954489, Trinity Sleeve(s), Delphi Consulting Group) and sleeve tubing pump connector (K910188, Pump Flowtron DVT Model AC500DVT from Huntleigh Technology). This substantial equivalence determination serves as the primary basis for meeting the acceptance criteria, as there are no specific performance standards for Compressible Limb Sleeves mentioned.

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not explicitly describe a formal "test set" or a new study in the way a clinical trial would. The basis for acceptance is stated as substantial equivalence to existing predicate devices. Therefore, information regarding a "sample size for the test set" or "data provenance" for a new study is not provided. The acceptance hinges on the comparison to already marketed and accepted devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Since no new clinical study or test set is described, there's no mention of experts establishing a ground truth for a new dataset. The "ground truth" for acceptance is effectively the established safety and efficacy of the predicate devices.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no new test set or study is described. The adjudication method would be the regulatory review process by the FDA to determine substantial equivalence.

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 medical sleeve and pump system aiming to prevent DVT/PE, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's acceptance is based on the established safety and efficacy of its predicate devices (K954489 and K910188), which were previously cleared by the FDA. This implies that the predicate devices had already demonstrated acceptable performance based on historical data, clinical experience, and potentially their own submission data (though not detailed here for the predicates). The current submission relies on the direct comparison of the new device's design, materials, and intended use to these predicates.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that would require a "training set" in the computational sense.

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

Not applicable, as no training set for an algorithm is relevant to this device.

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