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To assist in the placement of AMT MINI Button feeding devices by providing temporary feeding tube stability during insertion through patient stoma tract.

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I am sorry, but the provided text from the FDA 510(k) letter for the "AMT Introducer: MINI Button Delivery System" does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The 510(k) letter is primarily a regulatory document confirming that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. It focuses on:

• Device Identification: Trade/Device Name, Regulation Number, Regulatory Class, Product Code.
• Regulatory Determination: Stating that the device is substantially equivalent, allowing it to be marketed.
• General Controls: Reminding the applicant of ongoing regulatory compliance requirements (annual registration, listing, good manufacturing practice, labeling, etc.).
• Indications for Use: What the device is intended to be used for.

There is no mention of:

• Specific performance metrics or acceptance criteria (e.g., accuracy, precision, reliability).
• Any study data, sample sizes, data provenance, ground truth establishment, or expert involvement.
• Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This type of information would typically be found in the more detailed technical sections of the 510(k) submission itself, which are not included in this letter.

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