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The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare ArthroWands are bipolar, single use, sterile, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

The Paragon T2 Wand with Integrated Cable is a part of the family of ArthroCare ArthroWands and is specifically indicated for resection, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures of the knee.

Consistent with the predicate device, the Paragon T2 Wand with Integrated Cable is compatible with the System 2000, Quantum, Quantum 2, or Atlas System Controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. The Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired.

The wand consists of an active electrode, temperature indicator epoxy, a return electrode, a spacer, insulation, a connector block, a bent bead blasted shaft, nylon tubing, and a handle that connects via an integrated cable to the controller. The cable consists of wires that communicate with the active and return electrodes as well as the controller.

The Paragon T2 Wand with Integrated Cable is a Coblation wand designed to effectively ablate articular cartilage with minimal thermal effect on surrounding tissue. This Wand incorporates a Temperature Indicating Marker (TIM) as a visual indicator to the user that the temperature around the tip has reached 43°C-57°C degrees.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in relation to a diagnostic or AI-driven medical device.

The document is a 510(k) premarket notification for the ArthroCare Corporation's Paragon T2 Wand with Integrated Cable. This device is an electrosurgical cutting and coagulation device, not a diagnostic imaging or AI product.

The relevant sections discuss:

• Performance Data: States that "Performance bench testing, including functional testing, ablation life, and biocompatibility testing were performed on the proposed Paragon T2 Wand with Integrated Cable, which demonstrated the modified temperature sensitive dye met the required specifications."
• Verification Testing: Lists various electrical and mechanical tests performed, such as "Visual Inspection," "TIM Color Change," "Ablation 1X/2X/3X Life Testing," "Coagulation Testing," and "Dielectric Withstand / HiPot Testing." The reported result is that "Both the Paragon T2 Wand with Integrated Cable and predicate device have substantially equivalent testing specifications and both performed within acceptance criteria. These results support that the Paragon T2 Wand with Integrated Cable and predicate device are substantially equivalent."
• Biocompatibility Testing: Confirms that "all testing demonstrates that the Paragon T2 Wand with Integrated Cable performs as intended and has acceptable mechanical properties when used in accordance with its labeling."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them in the context of AI or diagnostic performance, as this document pertains to a surgical instrument's mechanical and electrical performance.

However, based on the provided text, I can infer a general structure for how such criteria and studies are presented for this specific electrosurgical device:

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

The remaining points (2-9) are not applicable or cannot be answered from the provided text, as they relate to AI/diagnostic studies, which this document does not cover. Specifically:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices undergoing bench testing, not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for electrosurgical device performance is established through engineering and material science standards, not expert consensus on medical images or patient outcomes.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not relevant for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, the "ground truth" is defined by engineering specifications, material properties, and functional performance standards (e.g., specific thresholds for electrical safety, validated ablation capabilities, and biocompatibility standards).
8. The sample size for the training set: Not applicable. There is no AI model or "training set."
9. How the ground truth for the training set was established: Not applicable.

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