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The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

The Linvatec 10k Irrigation System is a peristaltic, microprocessor controlled pump system designed to provide liquid distention and irrigation during arthroscopic and laparoscopic procedures. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.

This 510(k) submission for the Linvatec 10k Irrigation System is a summary of safety and effectiveness, comparing the device to legally marketed predicate devices to establish substantial equivalence. It does not contain a study that proves the device meets specific performance acceptance criteria in the way a clinical or technical validation study for a novel device would.

Instead, the submission focuses on demonstrating that the new device has similar intended use, design, and technological characteristics to existing devices, and that any differences do not raise new safety or efficacy issues.

Therefore, the requested information elements related to detailed acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth are not applicable or not provided in this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. This document does not specify quantitative performance acceptance criteria or report specific device performance metrics against such criteria. The submission is focused on demonstrating substantial equivalence to predicate devices rather than proving performance against novel, pre-defined acceptance criteria through a dedicated study.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. No explicit "test set" in the context of a performance study is described. The assessment focuses on comparing the design and characteristics of the new device to predicate devices.
• Data Provenance: Not applicable as no specific test data set is referenced in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not Applicable. This submission does not describe a study involving human experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study was not conducted or mentioned. This type of study is typically for assessing human performance with and without AI assistance, which is not relevant to an irrigation system's substantial equivalence claim.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is an irrigation system, not an AI algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used:

• Not Applicable. Ground truth, in the context of performance validation for diagnostic or AI devices, is not relevant here. The "truth" in this submission is the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design and characteristics of the Linvatec 10k Irrigation System are compared to existing predicate devices.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

Summary of Substantial Equivalence Claim:

The document states:

• "The Linvatec 10k Irrigation System is similar in intended use, design and technological characteristics as the Apex® Universal Irrigation System (Linvatec Corporation) and Hydro-Flex Li Laparoscopic Irrigation System (Davol Incorporated)."
• "Testing has been conducted to assure the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy."

This indicates that the "study" for this 510(k) was a design and technical comparison supported by internal testing (not detailed in this summary) to ensure that the variations from the predicate devices do not introduce new risks or compromise effectiveness. The acceptance criteria essentially stem from the safety and performance profile of the predicate devices.

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