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For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.

The Clinicon C4 CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue.

The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200 microns.

The hand piece is manufactured from 304 surgical stainless steel.

The provided text is a 510(k) summary for the Clinicon C4 CO2 laser. It describes the device's characteristics and intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial results or performance testing reports for AI/software devices.

The 510(k) process for a device like a surgical laser primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against pre-defined acceptance criteria for, for example, diagnostic or AI-driven devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert information, adjudication methods, or MRMC studies, as this information is not present in the provided document for this particular type of device submission.

The document discusses:

• Device Description: Sealed, liquid and convection cooled CO2 surgical laser, DC excited, 0-25 watts output power, 10.6 micrometer wavelength, 200 micron spot size.
• Intended Use: Vaporization, incision, and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.
• Substantial Equivalence: Claimed to Sharplan 20C (K963229), JMED CHRYS (K913606), and Surgical Laser Specialties Ultra MD Laser (510k Number Unknown).

The 510(k) process demonstrates that the new device is "substantially equivalent" to a predicate device, meaning it is as safe and effective as the previously cleared device. This typically involves comparing technological characteristics, intended use, and performance data if relevant, but not necessarily a specific "acceptance criteria" study in the way you might see for an AI-powered diagnostic tool.

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