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The Noblex Long Pulse Alexandrite Laser is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of benign vascular lesions, benign pigmented lesions and wrinkles.

The Nobelx Long Pulsed Laser system produces a pulsed beam of coherent near infrared (755nm) light. This beam is directed to the treatment zone by fiber optic coupled to hand-piece. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid highly localized temperature increase to the target chromospheres such as Hair removal and Pigment treatment. This increases localized temperature of the chromospheres to smaller particles.

By directing the beam onto specific tissue locations, using different hand-pieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. This equipment is composed of the main body and a hand-piece which is an irradiation device and as an accessory part, protective goggles for protection of the worker. Operation principle: This equipment is controlled by a micro processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board.

Meanwhile, the control board connected to the touch screen is connected to the lamp of the hand-piece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser.

The provided document is a 510(k) premarket notification for a medical device called the "Noblex Long Pulse Alexandrite Laser." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding clinical acceptance criteria and the study proving it.

Here's an analysis of why the requested information cannot be fully provided from the given document:

• Nature of the Document: A 510(k) is a marketing clearance pathway in the U.S. that demonstrates a new device is as safe and effective as a legally marketed predicate device. It usually relies heavily on non-clinical performance testing (e.g., electrical safety, EMC, laser safety standards) and comparisons of design features and indications for use, rather than extensive clinical efficacy studies against pre-defined clinical acceptance criteria.
• Focus on Substantial Equivalence: The "Performance Testing" section primarily lists compliance with international electrical and laser safety standards (EN 60825-1, EN 60601-2-22, EN 60601-1, EN 60601-1-2). This is about regulatory compliance and product safety, not clinical efficacy or performance against specific clinical acceptance criteria for hair reduction, vascular lesions, pigmented lesions, or wrinkles.
• Absence of Clinical Study Details: The document does not describe any clinical study in the way outlined in your request (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance). The "Indications for Use" section defines 'permanent hair reduction' based on measurements at 6, 9, and 12 months after treatment, which implies a clinical outcome, but no study is presented to show how the Noblex device achieves this outcome or meets specific performance metrics.

Therefore, I cannot provide the requested table and study details directly from the provided text.

However, I can extract the following relevant information:

• Device Name: Noblex Long Pulse Alexandrite Laser
• Indications for Use:
  • Stable long-term or permanent hair reduction (defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime). Used for all skin types (Fitzpatrick I-VI) including tanned skin.
  • Treatment of benign vascular lesions.
  • Treatment of benign pigmented lesions.
  • Treatment of wrinkles.
• Regulatory Compliance (as a basis for performance, not clinical efficacy):
  • EN 60825-1:2007 (Safety of laser products)
  • EN 60601-2-22:1996 (Medical electrical equipment - safety of diagnostic and therapeutic laser equipment)
  • EN 60601-1:2006 (Medical electrical equipment - general requirements for basic safety and essential performance)
  • EN 60601-1-2:2007 (Medical electrical equipment - electromagnetic compatibility)

If a hypothetical clinical study were conducted, the acceptance criteria for "permanent hair reduction" might be derived from its definition (e.g., X% hair reduction at 6, 9, or 12 months), but this document does not present such a study or its results.

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