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The Ti Clip Applier is indicated for ligation of the vas deferens.

Ti Clip Applier

The provided text is a 510(k) clearance letter from the FDA for a device called "Ti Clip Applier." This document primarily focuses on the regulatory clearance process, substantial equivalence to a predicate device, and labeling requirements. It does not contain information about acceptance criteria, detailed study designs, or performance metrics from a study proving criteria were met.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

The document only states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" for 510(k) clearance, and it means the device is as safe and effective as a legally marketed predicate device. The letter also includes a labeling limitation regarding its effectiveness for permanent male sterilization not being evaluated in comparison to standard vasectomy procedures.

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