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The WONTECH Air Gap Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 980 - 2200 nanometers have received regulatory clearance. The Air Gap Fiber delivery devices are intended for use with any surgical laser configured with an SMA-905 connector.

The WONTECH Air Gap Fibers are available in 3 sizes. These are 272, 365 and 550 microns and designated as hard clad silica material. These sizes refer to the core diameters of the silica. All fibers are Low OH (hydroxide), especially adapted to delivering wavelengths of laser that are highly absorbed by water. However, for those wavelengths in which water absorption is not a limiting factor, Low OH fiber optic cables may be used as well. The fiber assemblies are configured with standardized SMA-905 connectors, which are the most commonly found connectors in use today. These Air Gap fibers are packaged in sterile, single use, peel away pouches for direct use in operating theaters. The Air Gap fibers are indicated for soft and hard tissue contact and prepared with a polished, flat distal end. The Air Gap fibers is standardized at 3 meters. These Air Gap Fibers may be used with laser outputs from 1-120 watts. The Air Gap Fibers are intended for use in laser surgical procedures including open, laparoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable.

The provided text describes specific details about WONTECH Air Gap Fibers in the context of an FDA 510(k) submission, primarily focusing on its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance details from a study, sample sizes, expert qualifications, adjudication methods, or MRMC studies for AI devices. The text explicitly states "No clinical studies were considered necessary and performed" and "There is no software available for this device."

Therefore, I cannot provide the requested information for an AI-based device, as the provided document is for a physical medical device (laser fiber) and does not involve AI or related performance metrics that would typically come from a clinical or standalone study as described in your prompt.

The document focuses on non-clinical bench tests for sterilization, biocompatibility, and packaging, which are relevant to the physical characteristics and safety of the laser fiber itself, not its performance in an analytical or diagnostic task for which AI might be used.

I can, however, extract the non-clinical test summary information regarding product validation:

Non-Clinical Test Summary (from the provided document):

• Sterilization: Bench tests demonstrated compliance with ISO 11737-2 2019, ISO 11737-1:2018, ASTM F1980-21, and ISO 11135:2014/Amd 1:2018.
• Software Validation: "There is no software available for this device."
• Biocompatibility: The Silica Core fiber, with limited patient contact (

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