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The Trinity II Single Chamber DVT System Pump (with 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. The intended patient population is adult with the environment of use being hospital, clinic.

The Trinity II Single Chamber DVT Pump is a device designed to reduce pooling of blood and increase venous blood flow in the lower extremities of recumbent patients. It uses compressible limb sleeves.

The provided text describes a medical device submission (Trinity II Single Chamber DVT Pump) seeking substantial equivalence to a predicate device. However, it does not contain acceptance criteria for the device's performance, nor does it detail any study proving the device meets specific performance criteria beyond electrical safety, EMI, alarm and timing tests, Y2K compliance, and risk analysis.

The submission focuses on demonstrating substantial equivalence to a predicate device (Huntleigh Technology, Inc. Flowtron DVT System AC500 Pump) based on similar indications for use, operating principles, and minor parameter differences (pump pressure range).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it is not present in the provided text.

Here's what I can extract based on the information available:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the text in the context of clinical or performance acceptance criteria for the device itself. The text mentions "Testing" for electrical safety, EMI, alarm and timing, Y2K, and risk analysis, but these are general safety and engineering tests, not performance acceptance criteria for the DVT pump's therapeutic effect.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable/Not provided. The submission does not detail any clinical performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. No clinical performance study is described.

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

Not applicable/Not provided. No clinical performance study is described.

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/Not provided. This device is a DVT pump, not an AI-assisted diagnostic tool.

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

Not applicable/Not provided. This device is a medical pump, not an algorithm.

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

Not applicable/Not provided. No clinical performance study is described.

8. The sample size for the training set:

Not applicable/Not provided. The submission does not describe any machine learning or AI component requiring a training set.

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

Not applicable/Not provided. The submission does not describe any machine learning or AI component requiring a training set.

Summary of available "testing" information:

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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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