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Tetrix™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. Tetrix™ Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Tctrix™ Cream is a non-sterile cream formulation intended for prescription use only. Clinical studies provided evidence that Tetrix™ Cream prevents nickel salts, neomycin and a mixture of fragrances from making contact with the skin.

The provided text describes a 510(k) summary for a medical device called "Tetrix™ Cream". However, it does not contain information regarding specific acceptance criteria, a scientific study proving the device meets those criteria, or details such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document states:

• "Clinical studies provided evidence that Tetrix™ Cream prevents nickel salts, neomycin and a mixture of fragrances from making contact with the skin. Please see clinical studies section." (Section 2.4 - Device Description)
• "Functional and performance testing has been conducted to assess the safety and effectiveness of Tetrix™ Crcam and the results are satisfactory." (Section 2.7 - Tests and Conclusions)

Despite these statements, the actual "clinical studies section" or "functional and performance testing" details are not included in the provided text. Therefore, I cannot extract the specific information requested in your prompt.

To answer your request, I would need access to the full submission, specifically the sections detailing the clinical studies and performance testing.

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