Search Results

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

The Resection Ablator is a combination of a 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 Resection Ablator is supplied sterile, single use. This submission describes a modification to the existing Trident Resection Ablator that received marketing clearance under 510(k)# K002088 on March 6, 2001.

The provided text describes a 510(k) premarket notification for a medical device called the Resection Ablator, a combination arthroscopic shaver blade and monopolar electrode. The submission aims to demonstrate substantial equivalence to existing legally marketed devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

The document is a regulatory submission for premarket clearance and focuses on:

• Device Identification: Trade name, common name, classification, product codes.
• Company Contact Information.
• Predicate Devices: Identifying previously cleared devices to establish equivalence.
• Device Description: Explaining the components and function.
• Intended Use: Specifying the medical procedures and conditions for which the device is designed.
• Substantial Equivalence Argument: Stating that the device is similar in design, technology, and intended use to existing devices, and that modifications do not raise new safety or effectiveness concerns.
• FDA Correspondence: The FDA's letter granting clearance based on the determination of substantial equivalence.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, study details, sample sizes, expert information, or ground truth methods because this information is not present in the provided text. The document states that "Performance testing has been conducted to show that the modifications to the Trident Resection Ablator do not raise any new questions regarding safety and effectiveness," but it does not describe the specific tests, their results, or the criteria used to evaluate them.

Ask a specific question about this device