(162 days)
Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience, judgment, and needs.
Vesocclude ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in multiple sizes.
The provided text describes a 510(k) submission for the Vesocclude Ligating Clip, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone studies) is not present in the document.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on substantial equivalence based on design, material, and metallurgical characteristics, rather than defined performance metrics with acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission does not describe a clinical performance study with a test set. The evaluation is based on non-clinical data, specifically metallurgical comparative analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As there is no clinical performance study with a test set, there are no experts involved in establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As there is no clinical performance study with a test set, there is no adjudication method.
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 information is not applicable/not provided. This device is a medical implant (ligating clip), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a medical implant, not an algorithm, so a standalone performance study in this context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. For this type of submission, the "ground truth" is typically established by physical and chemical properties and comparison to known predicate devices, rather than clinical outcomes or expert consensus. The "metallurgical comparative analysis" serves as the basis for comparison.
8. The sample size for the training set
This information is not applicable/not provided. The term "training set" is relevant for machine learning algorithms. This submission pertains to a physical medical device and does not involve a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no training set for a machine learning algorithm, there is no ground truth established in this context.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.