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The IFL Professional System is indicated for use in Dermatological and Plastic Surgery specifically for long term stable, or permanent, hair reduction.

In addition, the IFL Professional System is indicated for the treatment of benign pigmented lesions.

The IFL Professional is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.

The IFL Professional System is a pulsed Xenon flashlamp delivering energy in the 550 to 1200nm wavelength range. The system consists of a base unit containing the electronic control subsystems, an umbilical containing the electrical interconnection between the base unit and the handpiece, and the handpiece containing the Xenon light source, filter and finger switch.

It appears there is no information regarding acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the IFL Professional System, focusing on general information, predicate devices, product description, and indications for use, as well as the FDA's clearance letter.

Therefore, I cannot fulfill your request for the specific information about acceptance criteria and a study.

The provided text only contains:

• Device name: IFL Professional System
• Submitter: Cyden Ltd
• Contact Person: Dr. Mike Kiernan
• Preparation Date: January 14, 2005
• Predicate Devices: Palomar Estelux System, Candela GentleLase Plus, ICN NLite System
• Product Description: Pulsed Xenon flashlamp delivering energy in the 550 to 1200nm wavelength range.
• Indications for Use: Long term stable, or permanent, hair reduction; treatment of mild to moderate inflammatory Acne Vulgaris; treatment of benign pigmented lesions (the last one mentioned in the "Indications for Use" enclosure, but not in the main summary statement).
• Rationale for Substantial Equivalence: Same mode of action, similar output parameters, identical indications for use as predicate devices.
• Conclusion: Found substantially equivalent to predicate devices based on technological design, operation, and intended indications for use.
• FDA Clearance Letter Details: K050165, Regulation Number 21 CFR 878.4810 (Laser surgical instrument), Regulatory Class II, Product Code GEX.

There is no mention of:

• A table of acceptance criteria or reported device performance against such criteria.
• Any specific study conducted to demonstrate performance, including sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance studies, or details on ground truth establishment for either training or test sets.

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The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction.

In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations: and the treatment of benign pigmented lesions.

The IFL Professional System is a pulsed Xenon flashlamp delivering energy in the 530 to 1200nm wavelength range. The system consists of a base unit containing the electrical and electronic control subsystems, an umbilical interconnection between the base unit and the handpiece, and the handpiece which houses the xenon light source, filter and finger switch.

I'm sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary statement for the "IFL Professional System" and primarily focuses on establishing substantial equivalence to predicate devices based on identical technological characteristics and intended indications for use.

It explicitly states: "Not Applicable. Substantial equivalence to the predicate devices is claimed for identical technological characteristics and intended Indications for Use." This indicates that the approval was based on demonstrating similarity to already approved devices, rather than on presenting new performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested information.

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