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As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, menisous, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Specialties are:

• General Surgery
• Plastic Surgery,
• Podiatry
• Urology
• Gynecology
• Pulmonary Surgery
• Dermatology
• Gastroenterology
• Ophthalmology
• ENT
• Thoracic Surgery
• Oral and Maxillofacial Surgery

These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

The Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is a medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 2940 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

The provided text is a 510(k) summary for a medical device (laser system) and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for evaluating AI/algorithm-based diagnostic or screening devices.

Here's why the input does not allow for a complete answer to your request:

• Device Type: This document pertains to a laser surgical device (Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase), not an AI/algorithm-based system.
• Regulatory Pathway: The submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device. For non-diagnostic devices, this often relies on demonstrating similar technological characteristics and intended use, rather than extensive clinical performance studies comparing an algorithm's output to ground truth.
• No New Indications/Clinical Data: The summary explicitly states: "No new indications were sought in this premarket notification and no clinical data was presented." This confirms that performance data based on clinical studies, which would involve acceptance criteria, test sets, ground truth, and expert evaluation, was not part of this submission.
• Focus on Predicate Device Equivalence: The justification for safety and effectiveness is based on the "substantial equivalence" to existing, cleared predicate devices (K974039 and K971648) which already had their indications cleared.

Therefore, I cannot populate the table or answer questions 2-9 from the provided text. The information requested is relevant to AI/diagnostic/screening devices, which is not what this document describes.

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As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxillofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

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The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary and FDA clearance letter for a medical device (CLR 2940 Erbium CrystaLase).

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Continuum Biomedical CB Erbium/2.94), rather than presenting a performance study against predefined acceptance criteria. The clearance letter confirms that the device is substantially equivalent to legally marketed devices based on the indications for use.

Therefore, I cannot populate the requested tables and information as no such details are present in the provided text. The document states: "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns," which is a statement of belief for substantial equivalence, not a report of a study against acceptance criteria.

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