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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, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

This is a 510(k) premarket notification for a medical device (ArthroCare ArthroWands). It is not a study about an AI/ML device. Therefore, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria, device performance, study types (MRMC, standalone), sample sizes, ground truth establishment, or expert qualifications in the context of an AI/ML study.

The document primarily states that the proposed modifications to the ArthroCare ArthroWands are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." It asserts substantial equivalence to a predicate device (K082980) based on unchanged indications for use, technology, principles of operation, and sterilization parameters, with only material specification changes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from an AI/ML study, nor any of the other requested details related to such a study, because the provided text does not describe an AI/ML product or performance study.

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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, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

This document is a 510(k) summary for a medical device (ArthroCare ArthroWands) and does not contain the acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical validation reports for AI/CADe devices.

Instead, this document is focused on demonstrating substantial equivalence to a previously cleared predicate device for a modification in material. The relevant sections state:

• "This Special 510(k) proposes modifications in material for the ArthroCare ArthroWands, which were previously cleared in K052686 (October 5, 2005). The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s."
• "The modified ArthroCare ArthroWands, as described in this Special 510(k), are substantially equivalent to the predicate device. The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because it is not present in the provided text. The document's purpose is to show that a material change does not alter the device's safety or effectiveness, not to present a new performance study.

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