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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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1. The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.

The ARION is a 755 nm solid-state long-pulsed Alexandrite laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device. The EPI Zoom Ax transmission system consists of a hand piece attachment with a firmly attached fiber and a hand piece. The hand piece insert can be moved within the hand piece and determine the application and parameter ranges. The hand piece insert in the transmission system hand piece can snap into various positions. The number located closest to the hand piece indicates the spot diameter on the skin in mm (spot sizes: 6/8/10/12/14 mm). The integrated hand piece detection feature automatically shows the selected spot diameter on the laser display. The parameter range is also automatically adjusted for the corresponding range. The MedArt 928 scanner for ARION consists of a scanner with a connected transmission system and a spacer with a 8, 9, 10 and 12 mm spot size. The spacer determines the spot diameter on the skin and therefore the parameter range of the configurable energy densities as well. The spacers are inserted into the scanner as shown below and must be inserted into the scanner up to the limit stop position. The spacers now automatically sets a spot diameter of 8, 9, 10, and 12 mm on the skin; this is also shown automatically on the laser display. The parameter range is also automatically adjusted for the corresponding range. For epidermal cooling can be a cooling device adapted to the handpiece / scanner.

The provided text is a 510(k) summary for the Wavelight Arion device. A 510(k) summary typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria.

Based on the provided document, here's what can be extracted and what is explicitly stated as not presented:

Acceptance Criteria and Device Performance (Not presented)

The document explicitly states: "6. Performance Data None presented." This means that acceptance criteria and reported device performance against those criteria are not included in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, not on new performance data.

Therefore, the following table cannot be filled from the provided text:

Here's an analysis of the other requested information:

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable/Not provided, as no performance data or test set is mentioned.
• Data provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided, as no test set or ground truth establishment is mentioned.

4. Adjudication method for the test set:

• Not applicable/Not provided, as no test set or adjudication is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done or reported. This device is a laser system for hair removal, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device (laser system), not a software algorithm or AI model.

7. The type of ground truth used:

• Not applicable/Not provided, as no performance data or ground truth is mentioned. The submission is based on substantial equivalence.

8. The sample size for the training set:

• Not applicable/Not provided, as no machine learning model or training set is mentioned.

9. How the ground truth for the training set was established:

• Not applicable/Not provided, as no machine learning model or training set is mentioned.

In summary: The 510(k) submission for the Wavelight Arion device explicitly states "Performance Data None presented." This implies that the device achieved marketing clearance through demonstrating substantial equivalence to predicate devices rather than by submitting new clinical or performance data against specific acceptance criteria. Therefore, most of the requested information, which pertains to performance studies and data, is not available in the provided document.

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The DuraLite-GL is a replacement fiber optic component for the Candela GentleLASE family of lasers. The DuraLite-GL may be used as a replacement part for ail procedures as cleared by the FDA for the Candela GentleLase family of lasers.

The DuraLITE-GL is an exact replacement component for the Candela GentleLASE Plus fiber optic.

Here's a breakdown of the acceptance criteria and study information for the DuraLITE-GL, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for a "test set" in the context of clinical or diagnostic performance. The testing described is for physical, optical, connectivity, and environmental performance of the device itself, rather than evaluating a diagnostic algorithm on a dataset.

Data Provenance: Not applicable in the context of this type of device and testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is an accessory to a laser, and the "ground truth" for its performance is related to its physical and functional equivalence to the predicate device, not clinical outcomes directly. No experts in a clinical "ground truth" capacity are mentioned for the test set.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No MRMC comparative effectiveness study was done. This document describes a replacement component for a laser, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical component, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the performance of the legally marketed predicate device (Candela GentleLASE Plus Fiber Optic). The study aimed to demonstrate that the DuraLITE-GL's physical, optical, connectivity, and environmental performance was "identical" to this predicate.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical component, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set is involved.

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