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The Arthroscopic Energy™ System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.

The ConMed Arthroscopic Energy System consists of a radiofrequency (RF) generator, probes or electrodes, a dispersive pad (as needed), and wired or wireless foot controls. The probes or electrodes are single-use devices used with the Arthroscopic Energy System for the purpose of wet field arthroscopic and orthopedic soft tissue resection (dissection), ablation (removal) and coagulation (hemostasis).

The generator is compatible with ConMed monopolar and bipolar probes or electrodes. The generator outputs are delivered to the probes or electrode handpieces within the specification ranges currently cleared and marketed by generators that have equivalent indications. The generator has a liquid crystal display (LCD) touch screen user interface. Power levels are assigned numeric values and are adjustable via the user interface. Control is accomplished via probe or electrode hand-piece controls, wired foot control or wireless foot control.

The ConMed Arthroscopic Energy System is an electrosurgical device. The descriptive text does not contain specific acceptance criteria, corresponding performance metrics, or details of a study that would provide such information. However, based on the provided text, the device underwent testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report specific device performance numerically (e.g., a specific ablation rate in mm/min, or a defined temperature accuracy range). Instead, it states that testing was completed to "confirm that the Arthroscopic Energy System provides equivalent results in resection, ablation, coagulation and hemostasis in comparison to the predicate device, ArthroCare® System 12000 (K082666)."

The types of testing performed are listed, which indirectly relate to performance attributes:

Reported Device Performance:
The document broadly indicates that the device "provides equivalent results" and "is as safe, as effective, and performs as well as" the predicate devices for their respective functionalities. No specific numerical performance results are provided in this summary.

2. Sample Size for Test Set and Data Provenance:

The document does not provide details on the sample sizes used for any of the tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench or in-vitro testing based on the descriptions ("probe testing," "system testing," "standards testing"). There is no mention of human subject data or clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable as the document does not describe a study involving expert assessment of images or clinical outcomes to establish a "ground truth." The evaluation focuses on the engineering and functional performance of the device against predicate devices and relevant standards.

4. Adjudication Method:

Not applicable, as there is no expert assessment or "ground truth" to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and functional comparisons, not through human reader performance analysis.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This concept is not relevant to the described device. The device is a medical instrument (electrosurgical system) that requires human operation; it is not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on achieving performance metrics comparable to legally marketed predicate devices and compliance with established industry standards (e.g., ISO, IEC). It's essentially a "performance equivalence" ground truth rather than an "expert diagnostic" or "pathology" ground truth.

8. Sample Size for Training Set:

Not applicable. The device is hardware (an electrosurgical system) and does not involve a "training set" in the context of machine learning or AI.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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