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Surgical Laser fibers are intended to be used to deliver the target tissue when used with any cleared/ certified surgical laser with operational wavelengths between 500mm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.

The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact mode during surgical procedures including via endoscopes and cystoscopes.

The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber. These devices are typically jacketed with ETFE, but some models are characterized by the presence of Nylon coating. The devices are 3.0 meters (9.8 ft) or 5.0 meters (16.4 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and several core diameter sizes (from 200 to 1000 microns) are offered.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The document is a 510(k) premarket notification for "Surgical Laser Fibers," which are physical medical devices, not AI/ML software.

The document discusses:

• Device Description: Surgical Laser Fibers, their materials, lengths, connectors, and core diameters.
• Modifications: Addition of 5.0-meter long fibers and nylon-jacketed fibers.
• Performance Data: Mentions biocompatibility testing, reprocessing validation testing, and initial EtO validation testing against ISO standards.
• Comparison with Predicate Devices: States that the device is substantially equivalent to previously cleared predicate devices (K160513 and K170366).
• Indications for Use: Describes how the laser fibers are intended to be used with surgical lasers.

None of the requested information (acceptance criteria for AI/ML performance, test set sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is applicable or present in this regulatory submission for surgical laser fibers.

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