(323 days)
Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation
Reusable bipolar forceps
This document is a 510(k) clearance letter from the FDA for a Reusable Bipolar Forceps manufactured by Modern Medical Equipment Manufacturing Ltd. It states that the device is substantially equivalent to legally marketed predicate devices.
However, a 510(k) clearance letter does not typically contain the detailed acceptance criteria and study results you are asking for. This type of information is usually found in the original 510(k) submission document, which is a much more extensive technical file that sponsors submit to the FDA.
The provided document doesn't include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Details on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- The type of ground truth used or sample sizes/ground truth establishment for training sets.
The letter simply provides the regulatory decision that the device is substantially equivalent for the Indications For Use stated in the enclosure. The enclosure (Page 2 of the document) confirms the intended use: "Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation."
Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and the study that proves the device meets them because that information is not present in this 510(k) clearance letter.
To get the information you're looking for, one would need to access the full 510(k) submission (K032327) that Modern Medical Equipment Manufacturing Ltd. submitted to the FDA.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.