(21 days)
The ORA-50 S AutoTemp ElectroThermal Generator ("ORA-50 S") and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The ORATEC Interventions ORA-50 S AutoTemp ElectroThermal Spine System ("ORA-50 S") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for the coagulation of soft tissue during a variety of spine procedures. The ORATEC ORA-50 S is specifically designed for use with ORATEC spine probe devices, although it may be used with any ORATEC electrosurgical or electrothermal probe.
Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use. A programmed temperature profile mode specifically designed for use with the ORATEC SpineCATH™ device ("SpineCATH Intradiscal Catheter", K974464) offers the convenience of selecting a treatment profile.
The provided text is a 510(k) summary for the ORA-50 S AutoTemp ElectroThermal Spine System. It focuses on establishing substantial equivalence to a predicate device based on intended use, operating principle, and hardware configuration. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions regarding studies, sample sizes, expert involvement, or ground truth. The document describes a regulatory submission for a medical device, which is different from a clinical study report.
The relevant information from the document is:
- Device: ORA-50 S AutoTemp ElectroThermal Spine System and Accessories
- Intended Use: For general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes.
- Predicate Device: ORA-50 S Programmable Spine System (K974464)
- Comparison: The ORA-50 S AutoTemp Spine System is a software modification of the predicate, sharing the same intended use, operating principle, and hardware configuration.
Missing Information:
All the specific points requested regarding acceptance criteria, device performance, study types, sample sizes, expert involvement, and ground truth are not present in the provided text. This document is a regulatory submission demonstrating substantial equivalence, not a detailed clinical study report.
§ 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.