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LEONI™ Laser Fibers (BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors and are indicated for use in laser-based surgical applications and procedures that are performed with compatible lasers operating at wavelengths between 500nm and 2200nm, which have been cleared.

The fiber optic delivery systems are accessories designed to deliver optical energy to soft or fibrous tissue in general surgical applications, in combination with any SMA-compatible laser system also indicated for the same applications.

They are composed of silicon, polyimide, acrylate, and polyamide.

The device systems are available in multiple sizes and with multiple tip shapes and handpiece configurations.

The fiber optics are available in reusable, and single use disposable devices that are prepackaged sterile. The reusable fiber optic systems may be reused only after the optical fiber tip is cleaned according to the Instructions for Use.

This document is a 510(k) premarket notification for LEONI™ Laser Fibers. It confirms that the device is substantially equivalent to legally marketed predicate devices and does not contain information about acceptance criteria or specific study outcomes that would typically be found in a performance study report for AI/ML devices.

Therefore, I cannot provide the requested information from the provided text. The document outlines the regulatory approval process for a medical device (laser fibers) and focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a novel performance study with acceptance criteria.

Specifically, the document states:

• No animal testing or human clinical testing was required for this product category.
• Laboratory testing was conducted on technological characteristics such as laser power, pull testing, optical performance, and mechanical performance. However, these are general categories of tests, and specific acceptance criteria or detailed results of these tests (e.g., performance metrics, sample sizes, ground truth) are not provided in this summary.
• Sterilization and biocompatibility testing were also performed but again, the detailed acceptance criteria and specific outcomes from these tests are not present in this summary.

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