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The Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:

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

Dermatology and Plastic Surgery
Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery

GI, GU, GYN and Pulmonary Surgery
Orthopedic Surgery
Thoracic Surgery
Ophthalmology
Podiatry
General Surgery

Protégé and Protégé LP Er: YAG Laser Systems and Accessories

This document is a 510(k) clearance letter from the FDA for the Protégé and Protégé LP Er:YAG Laser Systems and Accessories, dated November 3, 1997. It explicitly states that the devices are substantially equivalent to pre-amendments devices.

Therefore, this document does not contain information related to specific acceptance criteria, device performance studies, or AI/software validation as presented in the request.

The concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as detailed in the prompt (e.g., sample size, expert ground truth, MRMC studies, standalone performance) typically applies to more modern submissions, especially for AI/ML-driven devices, or devices requiring more extensive clinical evidence beyond substantial equivalence to a predicate.

Thus, I cannot extract the requested information from the provided text.

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