(183 days)
The indications for the use of the DuoClip Titanium Clips are the same as those for a Hemostatic Clips (Product Code 79MCH, Class1, Regulation# 878.4300). The indications is for ligating blood vessels.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA regarding the "DuoClipper Titanium Clips" (later referred to as DuoClip Titanium Clips). It is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices for the indication of "ligating blood vessels." Substantial equivalence means that the device is as safe and effective as a legally marketed device that is not subject to premarket approval.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI. (This device is a physical clip, not an AI or imaging device).
- A standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.