Search Results

The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.

The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.

The provided document, a 510(k) Pre-Market Notification for the Miltex Ligating Clip, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria or a study proving those criteria are met. Therefore, much of the requested information cannot be found in the provided text.

Here is what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The document states that the Miltex Ligating Clip functions "in the same manner as the predicate device" and is "as safe, as effective, and performs as well as the Horizon Ligation System (K982313)."

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The submission relies on a comparison to a predicate device rather than a new clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as there's no mention of a test set or ground truth established by experts in this context. The claim is based on substantial equivalence to the predicate device.

4. Adjudication method for the test set:

This information is not provided as there's no mention of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a physical ligating clip, not an AI-powered diagnostic or assistive technology.

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

This is not applicable. The device is a physical ligating clip, not an algorithm.

7. The type of ground truth used:

This information is not explicitly stated in the context of a "ground truth" for a study. The "truth" in this submission relies on demonstrating the physical and functional similarity to a legally marketed predicate device. This is a regulatory pathway of "substantial equivalence" rather than proving new efficacy from scratch.

8. The sample size for the training set:

This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.

9. How the ground truth for the training set was established:

This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.

In summary, the Miltex Ligating Clip's acceptance relies not on a clinical trial with specific performance criteria and ground truth, but on demonstrating "substantial equivalence" to a legally marketed predicate device (Horizon™ Ligation System by Weck Closure Systems, K982313) based on material, design, dimensions, and intended use. The document asserts that due to these similarities, the Miltex Ligating Clip is "as safe, as effective, and performs as well" as the predicate.

Ask a specific question about this device