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Single Use CO2 Laser Fiber is indicated for the ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.

Single Use CO2 laser fiber is a single use hollow fiber compatible to CO2 laser systems with the following specifications:

• equipped with F-SMA receptacle connector; ●
• equipped with a CO2 laser source, emitting radiation at 10.6 µm wavelength with pulsed and continuous wave (CW) emission mode;
• . able to produce a beam of maximum 300 µm diameter with maximum 30 mrad divergence at the fiber input plane;
• . with a maximum power of 40 W;
• equipped with an internal compressed air delivery system capable to generate a positive air flow ● inside the fiber tube;

The fiber structure is reported in Figure 1. It is composed of two layers: a capillary tube made of fused silica and a jacket made of ETFE. The cavity is covered by two films: the outer one is made of silver and the inner one is made of silver iodide. Silver, due to its high reflectivity, allows laser beam reflection and, thus, propagation inside the cavity. The addition of a silver iodide film from oxidation. A summary of fiber materials is reported in Table 2. Such materials represent patient contacting materials. D1, the lumen diameter, also corresponds to the laser beam diameter.

Optical fiber main components are shown in Figure 2. It is equipped with a SMA905 connector to be coupled to the laser system and a code plug that, for laser systems equipped with a code plug connector, allows the laser device to detect the fiber presence. A protective cap, to be removed before use, is placed on the fiber tip. Strain relief protects the fiber from mechanical stress at the connector side.

This kind of fiber needs to be connected to a laser system with an internal compressed air system. An air flow inside the fiber lumen is necessary to both cool the fiber and keep it free from debris.

This document describes the 510(k) summary for the Single Use CO2 Laser Fiber (HAF005001). It does not contain information about an AI/ML device or its acceptance criteria and study data. The document focuses on demonstrating substantial equivalence to a predicate laser fiber through technical specifications, indications for use, and non-clinical bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI/ML device meets them, as the provided text pertains to a laser medical device, not an AI/ML product.

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