(168 days)
The SERFAS Energy System is indicated for resection ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle and wrist.
The SERFAS Energy System is a bipolar high frequency electrosurgical system comprised of an electrosurgical generator, a series of disposable, single use, probe styles, and a footswitch.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for the SERFAS Energy System, which describes its intended use, predicate devices, and concludes with an assessment of substantial equivalence.
It does not include details on:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about test sets.
- Number and qualifications of experts, or ground truth establishment methods.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used.
- Training set sample size or how its ground truth was established.
This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed presentation of performance study results against specific acceptance criteria.
§ 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.