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As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination.

The Volmed Operation Drape is a sterile incise drape composed of a transparent mat polyurethane film coated on one side with an acrylic medical grade adhesive, supported by peelable white, silicon coated, double sided polyethylene protected release paper. The other side of the polyurethane film is protected by a polyethylene film which is removed after application of the drape to the surqical site.

Volmed Operations Drapes are supplied in 10 cm x 10 cm x 20 cm, 20 cm x 20 cm, 20 cm x 40 cm and 30 cm x 60 cm sizes in individual packages sterilized by gamma irradiation.

The biocompatibility of the device has been established by in vitro cytotoxicity, subcutaneous implantation (guinea pig), and dermal irritation (rabbit) tests. A repeat insult patch test in human volunteers showed that the material does not induce irritation or allergic contact dermatitis. In addition, a microbial permeability study with S. aureus was performed to demonstrate the effective performance of the drape as a bacterial barrier.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Volmed™ Operation Drape:

Based on the provided text, the Volmed™ Operation Drape is a sterile surgical incise drape. The document focuses on demonstrating its equivalence to a predicate device (Steri-Drape® Surgical Incise Drapes) and its safety and effectiveness.

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

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

• In vitro Cytotoxicity: Sample size not specified.
• Subcutaneous Implantation (guinea pig): Sample size not specified.
• Dermal Irritation (rabbit): Sample size not specified.
• Repeat Insult Patch Test (human volunteers): Sample size not specified.
• Microbial Permeability Study (S. aureus): Sample size not specified.

The data provenance (country of origin, retrospective/prospective) is not specified for any of these tests.

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)

This device submission does not involve a diagnostic imaging AI algorithm and therefore, the concept of "experts used to establish ground truth" in the way it's typically applied to AI in medicine (e.g., radiologists, pathologists) is not applicable. The "ground truth" for this device revolves around established biological and physical performance standards (e.g., absence of cytotoxicity, effective microbial barrier).

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

This is not applicable as the studies described pertain to material science, biocompatibility, and microbiological performance, not expert consensus on medical images or clinical diagnoses.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a sterile surgical drape.

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

No, a standalone algorithm performance study was not done. This device is a physical product (a surgical drape), not a software algorithm.

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

The "ground truth" for the Volmed™ Operation Drape was established through:

• Established laboratory protocols and standards for in vitro cytotoxicity, subcutaneous implantation, and dermal irritation tests.
• Direct observation/measurement of irritation/allergic reactions in human volunteers.
• Microbiological testing against S. aureus to demonstrate barrier effectiveness.

Essentially, the ground truth is based on scientific, empirical evidence from standardized biological and microbiological testing, rather than human expert interpretation of complex data (like pathology or imaging).

8. The sample size for the training set

Not Applicable. This document describes a physical medical device, not a software algorithm that requires a training set.

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

Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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