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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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The VasClip is intended for ligation of the vas deferens.

The VasClip is a small polymeric self-locking clip that encircles the vas deferens and provides ligation. The device is identical to the Hem-O-Lok device in materials, manufacturing methods and sterilization cycle. The device is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.

The provided text states that "As the VasClip is identical to the Weck Closure Systems Hem-o-lok ligating clip, no additional testing was required." The acceptance criteria for the VasClip are therefore implicitly tied to the performance and clearance of its predicate device, the Hem-O-Lok ligating clip (K003337).

However, a study was conducted. The text mentions: "A study involving 124 men was conducted at a single center. The results of this study confirm the indication for ligation of the vas deferens." This study was conducted to confirm the indication for the ligation of the vas deferens, which is already a broader indication for the predicate device.

Given the information, we can deduce the following:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 124 men
• Data Provenance: Single center, retrospective or prospective is not explicitly stated. The nature of "confirming the indication" suggests it was likely a prospective study or an observational study following the use of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the text. The text does not detail how the "results of this study confirm the indication."

4. Adjudication Method for the Test Set:

This information is not provided in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The study involved 124 men and aimed to confirm the indication, not to compare human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is a physical ligating clip, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The text states "The results of this study confirm the indication for ligation of the vas deferens." The ground truth would likely be clinical success in achieving ligation, which could be measured by post-procedure patency tests or clinical follow-up. However, the specific method for establishing this clinical ground truth is not detailed.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical ligating clip, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This question is not applicable as the device is a physical ligating clip, not an algorithm that requires a training set.

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