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The Trident Resection Ablator is intended to be used in arthroscopic procedures for resection and ablation of soft tissue, and hemostasis of blood vessels.

The Trident Resection Ablator is a combination of a 4.2mm Linvatec arthroscopic shaver blade and a Linvatec UltrAblator® monopolar electrode. The product configuration combines the mechanical resection of a shaver blade and the ablation and hemostasis functions of an electrode. The Trident Resection Ablator is supplied sterile, single use.

The modification to the Trident Resection Ablator described in this Special 510(k) is a change in the material formulation of the electrical insulation coating. This modification does not affect the device's intended use, fundamental scientific technology, performance specifications or labeling.

This document is a 510(k) summary for the Trident Resection Ablator, a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices rather than presenting a study to prove performance against specific acceptance criteria.

Therefore, the requested information elements related to performance studies (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets) cannot be extracted from the provided text.

The document explicitly states that the modification to the Trident Resection Ablator is a "change in the material formulation of the electrical insulation." It also notes that "This modification does not affect the device's intended use, coating, fundamental scientific technology, performance specifications or labeling."

The basis for market clearance is that "Testing has been conducted to assure that the change in the material formulation of the insulation coating does not raise any new issues regarding safety and effectiveness." This testing is not detailed in terms of specific performance metrics or acceptance criteria as would be found in a clinical or analytical performance study. Instead, the focus is on confirming that the material change does not negatively impact the device's equivalence to existing, already cleared devices.

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