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Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important.

Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).

Kleenaseptic is a ready-to-use, spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices prior to terminal sterilization/high-level disinfection in healthcare environments.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that "Kleenaseptic" meets such criteria. The document is a 510(k) summary for a general purpose disinfectant, establishing its substantial equivalence to a legally marketed predicate device based on its EPA registration.

The text does include:

• Device Name: Kleenaseptic
• Intended Use: A general purpose disinfectant for cleaning and disinfecting equipment surfaces and non-critical devices in healthcare environments, effective when used for 10 minutes at room temperature (69°F/20°C).
• Substantial Equivalence Basis: EPA registration number 46781-7 and the EPA-stamped approved label, in conformance with FDA "Guidance on the Content and Format of 510(k) Submission for General Purpose Disinfectants."

However, it does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results from a standalone algorithm-only performance study.
7. The type of ground truth used (beyond implying EPA approval implies a certain standard).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory submission focused on demonstrating equivalence through existing EPA registration, rather than a report detailing specific performance studies against predetermined acceptance criteria for a new medical device technology like an AI algorithm.

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