(233 days)
Be commonly used in Minimally Invasive Surgery for coagulation and cutting of tissue.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Laparoscopic Instrument, Electrode, and Cable. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding:
- Acceptance criteria and reported device performance.
- Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates that the regulatory review was based on the submitted 510(k) notification, which would have contained the study information. However, the study details themselves are not present in this clearance letter.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.