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The ENCAGE™ bipolar RF probe is intended to be used in conjunction with radiofrequency (RF) generators for percutaneous, laparoscopic, or intraoperative thermal coagulation of soft tissues.

The ENCAGE™ bipolar RF probe is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electrosurgical device that coagulate/ablate a region of soft tissue using bipolar RF energy. The device is designated for use in percutaneous, laparoscopic and intraoperative surgical procedures. The ENCAGE™ bipolar RF probe is used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cables to create radiofrequency lesions in soft tissue.

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the specific study proving the device meets them. The document is a 510(k) summary for the ENCAGE™ bipolar RF probe, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results.

Specifically, the document states:

• "Summary of Performance data" section (5.9) mentions that the device complies with ANSI/AAMI HF-18:2001 and IEC 60601-2-2:2006 standards. It also says, "Bench testing/functional testing performed on the ENCAGE™ bipolar RF probe demonstrates that this device is substantially equivalent to the predicate devices."
• It explicitly states, "No new safety or effectiveness issues have been raised."

This indicates that compliance with general standards and demonstrating equivalence through bench/functional testing was deemed sufficient for this 510(k) submission, and a detailed clinical performance study with specific acceptance criteria, sample sizes, ground truth, or MRMC studies, as you've requested, was apparently not part of this particular submission package or is not detailed in the provided summary.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. Information on MRMC comparative effectiveness studies or effect sizes.
6. Information on standalone (algorithm-only) performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document indicates that the device's performance was evaluated through "Bench testing/functional testing" against established standards to show substantial equivalence. However, it does not specify the detailed methodology, acceptance criteria, or results of these tests in the format you've requested for a performance study.

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