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The Odyssey ITM Dental Water unit with CAT filter is indicated for use as an in-line water disinfecting system to reduce microorganisms and particulate matter in the dental waterline.

Odyssey ITM Dental Water unit

I am sorry, but based on the provided document, I cannot answer your request. The document describes a 510(k) premarket notification for a dental water unit and focuses on regulatory approval rather than a study about the device's performance or acceptance criteria.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes, data provenance, or details of a test set.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Details about a standalone algorithm performance study.
• The type of ground truth used.
• The sample size for a training set.
• How ground truth for a training set was established.

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For use in sterilizing dental and surgical instruments such as extractor forceps with sirrated handles, IRIS scissors, and convex mirrors and handles, with all legally marketed models of MDT Harvey Chemiclaves, when use of chemiclave solution is indicated, and used according to the chemiclave cycle parameters, ( 132°C, 20 -27 psi, for 20 minutes per cycle). Not for use in water or steam type sterilizers

Vapophene - Chemical autoclave solution

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vapophene - Chemical autoclave solution," but it does not detail any performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. It only states that the device is "substantially equivalent" to legally marketed predicate devices.

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Ask a specific question about this device