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The AMSure Urethral Catherization Tray is intended for use in the drainage of urine from the bladder.

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The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSure Urethral Catheterization Tray.

Based on the content, this document is a regulatory approval letter and does not contain the detailed information required to describe acceptance criteria and study results for device performance.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance. This document solely focuses on regulatory approval, not on the technical details of a study.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Details about a standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The letter confirms the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a detailed technical performance evaluation that would typically involve acceptance criteria and study data as outlined in the request. The "Indications for Use Statement" on page 5 simply states the intended use of the device ("drainage of urine from the bladder") but does not provide performance metrics or acceptance criteria.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details based on the provided text.

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