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The Cutera Er: YSGG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue.
Dermatology and Plastic Surgery
Indications include: treatment of wrinkles and skin resurfacing.
Opthalmology
Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit.

The Cutera Er:YSGG Laser handpiece is an optional handpiece for the currently marketed Xeo and Solera Opus laser systems. The handpiece emits laser energy at a wavelength of 2790nm. The water cooled laser is located in the handpiece and utilizes a computer controlled scanner.

The provided text does not contain information related to specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The document is a 510(k) summary for the Cutera Er:YSGG Laser System, which focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study against predefined acceptance criteria.

The key points from the provided text are:

• Subject: Cutera Er:YSGG Laser Handpiece
• Purpose: To demonstrate substantial equivalence to predicate devices (Sciton Profile Er:YAG, BioLase Oculase MD, MLT Erbium:YAG, BioLase Waterlase).
• Rationale for Substantial Equivalence: The device shares similar indications for use, design features, and functional features as predicate devices, and is not believed to raise new questions of safety or effectiveness.
• Intended Use: Excision, incision, ablation, vaporization, and coagulation of soft tissue for dermatology/plastic surgery (wrinkles, skin resurfacing) and ophthalmology (tissue surrounding the eye and orbit).

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications, as it is not present in the provided 510(k) summary. This type of information is typically found in clinical trial reports or detailed validation studies, which are not included in this document.

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