Search Results

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.

Ask a specific question about this device

The Visu-Loc™ 5mm Clip Applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Not Found

The provided text describes an FDA 510(k) clearance letter for the Visu-Loc™ 5mm Clip Applier. It acknowledges the device's substantial equivalence to legally marketed predicate devices and details the regulatory classification and general controls. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance letter, not a detailed study report.

Ask a specific question about this device