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The equipment is used for human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
The equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,

Trixel CO2 Laser is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.
The equipment is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a CO2 Laser, focusing on demonstrating substantial equivalence to a predicate device rather than providing a performance study against predefined acceptance criteria.

The summary outlines:

• Device Identification and Intended Use: The proposed device (Trixel CO2 Laser/Trixel II CO2 Laser) is intended for human tissue vaporization and coagulation in various surgical specialties.
• Predicate Device Identification: The predicate device is the CO2 LASER SYSTEM (K101555) from ADVANCED TECHNOLOGY LASER CO., LTD.
• Device Description: Details the components of both Trixel CO2 Laser models.
• Non-Clinical Test Conclusion: States that bench tests were conducted to verify the proposed device met design specifications and was substantially equivalent. It lists compliance with several IEC standards (IEC 60825-1: 2007, IEC 60601-2-22: 2007, IEC 60601-1:1988+A1:1991+A2:1995, IEC60601-1-2:2001+A1:2004). These standards relate to laser safety, medical electrical equipment safety, and electromagnetic compatibility.
• Substantial Equivalence Conclusion: Compares the proposed device to the predicate device, highlighting similarities in product code, regulation number, class, maximum power, work mode, wavelength, mode structure, spot size, and pulse setting. It addresses minor differences (intended use, light arm, aiming beam, cooling system, power input) with analyses concluding they do not introduce safety or effectiveness problems.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies from the provided text. The document focuses on regulatory compliance through substantial equivalence, which primarily involves comparing the new device to an existing legally marketed device based on technical specifications and safety standards, rather than conducting new clinical performance trials with specific acceptance criteria.

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