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This product is designed to provide a direct method to remove fog from the endoscope and laparoscope.

The use of an anti-fog solution aid to eliminate troublesome cloudiness which prevents clear vision and poor picture images. After application of the solution the device is ready for use. All ingredients are sterile. The solution will not harm the lens and can be used as often as necessary.

This 510(k) submission describes an anti-fog solution for endoscopes and laparoscopes, not a medical device that requires a study to demonstrate performance against acceptance criteria in the typical sense (e.g., accuracy, sensitivity, specificity). The submission is focused on demonstrating substantial equivalence to predicate devices for its intended use, which is simply to prevent fogging. Therefore, most of the requested information about acceptance criteria and study details for device performance (such as sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.

Here's a breakdown based on the provided text, highlighting what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense for a performance study. The "performance" described is the solution's ability to eliminate troublesome cloudiness that prevents clear vision and poor picture images. The acceptance is based on the claim that "After application of the solution the device is ready for use." There are no quantitative metrics or thresholds provided in the document for this claim as it is a fundamental functional claim for an anti-fog solution.

2. Sample size used for the test set and the data provenance

Not applicable. No formal test set or corresponding data provenance is mentioned as this is a functional claim for an anti-fog solution, not a diagnostic or AI device requiring such validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" does not apply here. The effectiveness is a direct observation of the absence of fogging after application.

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

Not applicable.

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 is not an AI device.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. For a product claiming to prevent fog, the "ground truth" is simply the visual observation of whether fog is present or absent on the lens after application.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary of the Study (as inferred from the 510(k) submission):

The provided document is a 510(k) summary for a medical device called "Visual Endoscopic Non-Alcohol Ultracell Sponge (VENUS II) and Visual Endoscopic Non-Alcohol Urethane Sponge (VENUS I)" which also includes the "ULTRACELL ANTI-FOG KIT". The core "study" is the demonstration of substantial equivalence to predicate devices already on the market prior to May 28, 1976.

The "study" demonstrating the device meets its acceptance criteria is not a formal clinical trial or performance study with quantitative outcomes. Instead, it relies on:

• Statement of Intended Use: The device's purpose is "to provide a direct method to remove fog from the endoscope and laparoscope."
• Functional Claims:
  • It eliminates "troublesome cloudiness which prevents clear vision and poor picture images."
  • "After application of the solution the device is ready for use."
  • "The solution will not harm the lens."
  • "All ingredients are sterile."
• Substantial Equivalence: The FDA's review and determination that "the device is substantially equivalent for the indications for use stated... to devices marketed in interstate commerce prior to May 28, 1976." This implies that the sponsor provided information (chemical composition, manufacturing processes, safety data, etc., though not detailed in this specific document) that allowed the FDA to conclude that this new device is as safe and effective as existing legally marketed predicate devices for the same intended use.

In essence, for this type of basic anti-fog solution, the "study" is the submission itself, arguing that its properties and function are demonstrably similar to products already deemed acceptable by the FDA, therefore meeting its acceptance criteria by association and inherent functional design.

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