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The Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.

The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.

The Arthrex Synergy RF System consists of the Arthrex Synergy RF Generator/Console, Apollo RF probe/ablator and the Synergy RF Footswitch. The system is designed specifically to work together and is not compatible with any other electrosurgical generator.
The aspirating RF probe/ablator provides a bipolar RF probe/ablator handle, the black button adjusts the default power setting for the specific RF probe/ablator connected to the Synergy RF console; the button with the yellow ablate invokes the Ablate function and the blue coagulation button invokes the Coagulation function. A Synergy RF Footswitch can be connected to the front panel of the console to override the control buttons. The user has the option to override this feature through the console touch screen options.

The provided text describes the Arthrex Synergy RF System, an electrosurgical cutting and coagulation device. It includes a 510(k) summary, which details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does NOT contain detailed information about specific acceptance criteria (numerical thresholds for performance metrics) or a comprehensive study plan with sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.

The document indicates that "performance testing of the Arthrex Synergy RF System has been shown to be substantially equivalent to the predicate ArthroCare 12000 system by evaluation of coagulation/ablation zone measurements and/or visual similarity of coagulation/ablation of tissue samples, and with respect to the measured temperatures of adjacent tissue, in-vitro." It also states, "The submitted performance testing data demonstrated that the coagulation and ablation of the proposed device is substantially equivalent to the coagulation and ablation of the predicate device." This suggests a comparative study was performed, but the specifics are not provided.

Therefore, many of the requested details cannot be extracted from the given text.

Here's an attempt to answer based on the available information and noting what is missing:

1. A table of acceptance criteria and the reported device performance

Note: The document uses "substantially equivalent" as the primary acceptance criterion, rather than specific numerical thresholds. The methods used to determine this equivalence are briefly mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified, but the testing was conducted "in-vitro," suggesting laboratory-based testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The evaluation involved "evaluation of coagulation/ablation zone measurements and/or visual similarity," which implies expert assessment but no details are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, this does not appear to be an AI-assisted diagnostic device, but rather an electrosurgical device for cutting and coagulation. Therefore, an MRMC study related to human reader performance with AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not an AI algorithm; it's a medical device. The "performance testing" described refers to the device's physical capabilities in tissue, not an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" implicitly would be the objective measurements of coagulation/ablation zones and temperatures in tissue, and visual assessment of the tissue samples. This is determined through in-vitro testing.

8. The sample size for the training set

• Not applicable/Not specified. This is a medical device, not a machine learning model requiring a training set in the typical sense. Performance was compared to a predicate device.

9. How the ground truth for the training set was established

• Not applicable.

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