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The Model 70 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Model 500 electrosurgical generator) for use in electrosurgery and is designed for the following:

• Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.
• Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.
• Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
• Incorporate thermocouples for temperature feedback.
• Provide for local delivery of fluid.

This RITA device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy forming a spherical lesion 3 centimeters in diameter. The RITA device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible hypodermic tubing at the distal end of probe trocar insulation: fixed clear polyester shrink tubing handle: PVC and ABS with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through 6 pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: 4 temperature sensors at the periphery of the array depth indicators: Incremental 1 cm marks denote needle penetration depth

This document is a 510(k) premarket notification for the Model 70 Electrosurgical Probe. It details the device's description, intended use, and substantial equivalence to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.

The document states that "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." This indicates that there are no FDA-mandated, quantifiable performance standards or acceptance criteria for this type of device at the time of this submission. The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or performance study.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on regulatory clearance based on substantial equivalence, and not on performance studies with specific acceptance criteria as you've outlined.

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