(96 days)
The intended use of the Ultraclip II WING and Ultraclip II COIL is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
Not Found
I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, or performance metrics of the device (Ultraclip® II WING, Ultraclip® II COIL).
The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device. It confirms that the device can be marketed but does not include the detailed study results or acceptance criteria that would typically be found in a clinical study report or a more comprehensive submission document.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done and its effect size
- If a standalone performance study was done
- 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.