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The Resection Ablator is intended to be used in arthroscopic procedures for resection of soft tissue, 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 blado and a Lifratus s the mechanical resection of a shaver blade and the oblation and hemostasis functions of an electrode. The Resection Ablator is supplied sterile, single use. This submission describes the next generation of the Resection Ablator rnie oubline. The shaver blade portion of the device has been changed, as well as materials of the ceramic tip, insulation coating and electrode. The ceramic tip and electrode strip configuration have also been changed to extend nearer the distal tip.

The provided text is a 510(k) summary for a medical device called the "Resection Ablator." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance as would be expected for novel devices or those requiring PMA.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical trial. The information provided is primarily related to regulatory classification, device description, and a claim of substantial equivalence.

Here's an explanation of why the requested information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Performance Table (Item 1): The document does not define specific performance metrics or acceptance criteria (e.g., accuracy, sensitivity, specificity, or mechanical ratings) that the device was tested against in a formal study. It only states that "Performance testing has been conducted to show that the modifications to the Trident Resection Ablator do not raise any new issues regarding safety and effectiveness." It does not report the results of such testing against predefined criteria.
• Sample Size, Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Study, Type of Ground Truth, Training Set Size, and Training Set Ground Truth (Items 2-9): These items pertain to the methodologies and results of clinical performance studies, particularly those involving human readers or sophisticated AI algorithms requiring ground truth establishment. The 510(k) submission for this device does not include details of such studies. Instead, it relies on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device based on design, technology, and intended use, along with non-clinical performance testing.

Conclusion based on the provided text:

The information required to fill out the table and answer questions 2 through 9 is not present in the given 510(k) summary. The document focuses on regulatory approval based on substantial equivalence rather than a detailed performance study with explicit acceptance criteria and corresponding results.

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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