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The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.

The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.

Here's a breakdown of the acceptance criteria and the study details for the Fluid Barrier Knee-High Boots:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 35 samples were initially prepared, with 32 samples used for the passing/failing assessment.
• Data Provenance: Not explicitly stated, but the test (ASTM Method F1671-95) is a standardized laboratory test; it's retrospective in the sense that the test was conducted on manufactured samples.

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

• This device is a physical barrier product, and its performance is assessed through a standardized laboratory test (ASTM Method F1671-95). Therefore, there is no "expert" involvement in establishing ground truth in the traditional sense of clinical interpretation. The ground truth is determined by the objective results of the viral penetration assay.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) was used. The test results are objective and based on the presence or absence of ΦX174 on assay plates following the ASTM F1671-95 methodology.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This is not applicable for a physical barrier product being tested for viral penetration.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This is not applicable as the device is a physical product, not an algorithm. The performance described is inherently "standalone" in the sense that it's the product's performance under specific test conditions, without human interpretation influencing the result.

7. Type of Ground Truth Used

• The ground truth used is based on objective laboratory test results from the "Viral Penetration Test" ASTM Method F1671-95, which measures the passage of a surrogate virus (ΦX174) through the material.

8. Sample Size for the Training Set

• This information is not applicable. The device is a manufactured physical product, not a machine learning model, so there is no "training set."

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

• This information is not applicable, as there is no training set for this type of device.

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