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The Deflectable Electrosurgical Probes are disposable, monopolar electrosurgical devices intended for general surgical use in procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to be used with ORATEC ElectroThermal generators.

The Deflectable Electrosurgical Probes are disposable, monopolar electrosurgical devices designed to coagulate or to cut tissues. They provide minimally invasive access to the targeted tissues. The Deflectable Electrosurgical Probes are used in conjunction with ORATEC ElectroThermal generators to deliver monopolar radiofrequency (RF) energy for electro-coagulation and cutting of soft tissues. The Deflectable Electrosurgical Probes incorporate: A shaft with an RF energized tip to perform tissue coagulation; Optional tip configurations for various general tissue coagulation and cutting uses; A controllable, deflectable tip at the distal end of the probe to allow easier access to all tissue surfaces; A handle, with cable connector and deflecting mechanism at the proximal end.

The provided text is a 510(k) summary for the ORATEC Deflectable Electrosurgical Probes, which explicitly states that it is a summary of safety and effectiveness information. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria and a detailed analysis of device performance.

Therefore, the information required to answer your request (acceptance criteria, specific study details, sample sizes, expert qualifications, etc.) is not present in the provided text. The document's purpose is to facilitate regulatory clearance by showing similarity to an already approved device, not to detail the results of a primary performance study against explicit acceptance criteria.

The key points from the document are:

• Device: ORATEC® Interventions, Inc., Deflectable Electrosurgical Probes
• Intended Use: Disposable electrosurgical devices for general surgical use in procedures where electro-coagulation and cutting of soft tissues is desired. Used with ORATEC ElectroThermal generators.
• Predicate Device: ORATEC® Interventions, Inc., Electrosurgical Probes, K965007
• Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "Based on the information presented here, the ORATEC Interventions Inc., Deflectable Electrosurgical Probes are substantially equivalent to the Electrosurgical Probes manufactured and distributed by Oratec Interventions, Inc."

Since no performance study with acceptance criteria is described, I cannot fill out the requested table or address the specific questions about sample sizes, experts, ground truth, or MRMC studies.

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