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The Protégé II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, agans and glands.

Dentistry: Soft tissue (incision, excision, ablation and coagulation)

Dermatology Plastic Surgery: Indications include epidermal nevi, clangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacial skin lesions, and performing: diagnostic biopsies.

General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrown and uretira (includes condylomaacuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.

Gynecology: Indications include cervical intracoithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

Oral Maxillofacial: Indications include benign oral tumor, oral and glossal lesions and gingivectorny.

Otorhinolaryigology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia.

Ophthe mology: Indications include soft tissue surrounding the eye and orbit and anteriorcapsulotomy.

Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae andmatrixectorny.

Arthrescopy: Including open and laparoscopic procedures

Orthopedic Surgery

Thoracic Surgery

Protégé II (tm) Er: YAG Laser System and Accessories (Upgrade)

The provided document set is a 510(k) premarket notification letter for the Protégé II (tm) Er: YAG Laser System and Accessories, dated July 3, 1998. This document confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given text. The letter primarily focuses on the regulatory approval of the device based on substantial equivalence, rather than detailing specific performance criteria or study results.

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