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The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.

Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.

The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition, the power cord, foot switch, and the door plug are connected there. The touch-screen serves as the main control panel.

The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.

The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.

The provided text is a 510(k) Summary for a medical device (FlexSys). This type of document is for demonstrating substantial equivalence to a predicate device, not typically a full clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would be evaluated. Lasers are hardware devices, and their performance is primarily assessed through compliance with safety and performance standards, not diagnostic accuracy metrics like sensitivity or specificity.

Therefore, many of the requested points are not applicable or cannot be extracted from this document, as it describes a laser system for dermatological procedures, not a diagnostic AI device.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) or not provided:

1. Table of acceptance criteria and reported device performance:

This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and safety standards, rather than specific performance metrics against clinical acceptance criteria for a diagnostic purpose. The "performance" for a laser device often refers to its safety and specified output parameters (e.g., wavelength, power, pulse duration), which are generally demonstrated through engineering and electrical/laser safety testing reports rather than clinical outcome measures with predefined acceptance thresholds.

2. Sample size used for the test set and the data provenance:
N/A. This is a laser device, not a diagnostic AI device that would typically have a "test set" of clinical data to evaluate algorithms. Its performance is evaluated through engineering and safety testing. The document states "Testing reports were submitted for the following standards," implying laboratory/bench testing rather than clinical data from a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. As this is not a diagnostic AI device, there is no "ground truth" in the context of expert diagnosis or interpretation of images/data for a test set. The validation revolves around engineering specifications and safety compliance.

4. Adjudication method for the test set:
N/A. Not applicable for a laser device's regulatory submission focused on engineering and safety standards.

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:
N/A. This device is a laser system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
N/A. Not applicable to a laser device.

7. The type of ground truth used:
N/A. The "ground truth" for a laser device would be its physical properties and measured output (e.g., wavelength accuracy, power output, beam profile) confirmed against engineering specifications, and its safety compliance proven through adherence to international standards (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set:
N/A. This is a hardware device; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
N/A. Not applicable to a hardware device.

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The device FlexSys is a multi-modality skin surface treatment . Depending on the chosen modules the intended use and the mode of operation varies.

Module MultiLite:

The intended use of the device FlexSys with MultiLite module is:

· Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

· Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

· Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.

Module Green 532:

The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.

Module Yellow 577:

The GME FlexSys with module Yellow 577 (wavelength: 577mm) is intended for treatment of benign vascular and benign pigmented lesions.

The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.

The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel.

The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.

The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.

The provided text is a 510(k) summary for the GME FlexSys device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it explicitly states:

"Clinical Performance Data: None"

This means that no clinical study was conducted to prove the device's performance against specific acceptance criteria. The acceptance criteria and the study proving the device meets them are therefore not available in this document.

The document primarily focuses on demonstrating substantial equivalence based on:

• Technological similarity: Comparing the FlexSys's technology (laser and LED light sources) to predicate devices.
• Physical output characteristics: Assessing that the physical output of the FlexSys is similar to predicates.
• Indications for Use: Comparing the intended uses of the FlexSys modules to those of predicate devices.
• Design, materials, and performance: General comparisons to predicate devices without specific quantitative clinical data.
• Nonclinical tests: Conformance with standards for safety (electrical, EMC, laser safety), software validation, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided document.

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The GME TwinScan 808/755 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.

The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).

The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.

The TwinScan 808/755 Laser System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner. The device may be configured with 808 nm or 755 nm Applicators, in two treatment area sizes, at the factory. The TwinScan 808/755 Laser System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the TwinScan 808/755 Laser System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore (in this case, hair follicle). Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

I am sorry, but the provided text does not contain information on the acceptance criteria and a study that proves the device meets those criteria. The document is an FDA 510(k) premarket notification for the "TwinScan 808/755 Laser System", primarily focusing on establishing substantial equivalence to predicate devices. It lists device specifications and indications for use, but does not detail acceptance criteria or specific clinical study results for device performance against those criteria. It only mentions that performance data was submitted, specifically "Testing reports for IEC 60825-1 and IEC 60601-2-22" and "IEC 60601-1 and IEC 60601-1-2", which refer to international safety standards for laser products and medical electrical equipment. These are not clinical studies demonstrating the effectiveness of the hair removal or permanent hair reduction claims.

Therefore, I cannot provide the requested table or detailed information regarding sample sizes, ground truth, expert qualifications, or MRMC studies.

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The GME LinScan Lite 808 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

The LinScan Lite 808 Laser System is a diode laser designed to be used in Dermatological practice for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.

The LinScan Lite 808 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner.

The LinScan Lite 808 System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit.

A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan Lite 808 System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore. Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

The provided text describes a 510(k) summary for the GME LinScan Lite 808 Laser System, which is a medical device for hair removal and permanent hair reduction. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It is crucial to understand that this document does NOT describe the performance of an Artificial Intelligence (AI) device, nor does it present "acceptance criteria" or a "study that proves the device meets acceptance criteria" in the context of AI device performance.

The acceptance criteria and study described in this document are related to the substantial equivalence of a laser system to a predicate device, focusing on its physical characteristics, safety standards (IEC certifications), and intended use, rather than an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for information related to an AI device's acceptance criteria and performance study derived from this document. The document discusses:

• Device Type: A laser system for hair removal.
• Regulatory Pathway: 510(k) premarket notification for substantial equivalence.
• Performance Data (as presented): Conformance to IEC standards (e.g., IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-2), which are safety and electrical performance standards for medical electrical equipment and laser products. These are not performance metrics for an AI algorithm.
• No mention of:
  • AI algorithms or their performance.
  • Test sets, training sets, or ground truth for AI.
  • Expert readers or adjudication for AI.
  • MRMC studies for AI.
  • Sensitivity, specificity, AUC, or other typical AI performance metrics.

In summary, the provided text does not contain any information about an AI device's acceptance criteria or performance study.

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The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

The ExSys 308 is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The ExSys 308 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button, speaker), which controls an applicator unit. The applicator unit contains the UV light source. The model number is ExSys 308. The ExSys 308 System includes the following accessories: Power cord, optional foot switch, laser protective goggles, applicator holder, and set of treatment tips. The treatment tip (a distance spacer) is the only patient contacting part of the system. There are no single use parts in the ExSys 308 System.

This document is a 510(k) premarket notification for the GME ExSys 308 System, an ultraviolet light device for dermatological disorders. It aims to demonstrate substantial equivalence to a predicate device, the Quantel 308 Dermatological Excimer System. The information provided focuses on the device's technical specifications and safety testing, typical for a substantial equivalence claim under 510(k) for a Class II device. It does not contain a clinical study with acceptance criteria and device performance as typically understood for AI/ML device evaluations.

Therefore, the following points address what can be extracted from the provided text, and explicitly states where information is not available given the nature of this submission.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for a physical medical device (UV lamp) and focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, rather than clinical performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, accuracy).

Note: For devices subject to 510(k), "acceptance criteria" are generally derived from demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of technical specifications and adherence to recognized standards. Clinical performance metrics like sensitivity/specificity are not typically required for this type of device.

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

• Sample Size for Test Set: Not applicable. This submission does not involve a "test set" in the context of an AI/ML algorithm evaluation using patient data. It describes nonclinical safety and performance testing of a physical device.
• Data Provenance: Not applicable. The testing described is nonclinical (e.g., electrical safety, optical performance).

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

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical expert consensus, is not relevant to the nonclinical testing described for this device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with evaluating AI interpretation or diagnostic assistance systems used by human readers, which is not the nature of this physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone study (in the context of an algorithm's performance) was not done. The device is a direct treatment tool, not an AI/ML diagnostic or interpretive algorithm. The reported performance refers to the physical output and safety of the UV light system itself.

7. Type of Ground Truth Used

• Type of Ground Truth: For the nonclinical performance and safety testing, the "ground truth" refers to established engineering standards (e.g., IEC 60601-2-57, EN 60601-1, EN 60601-1-2) and the known specifications and performance of the predicate device. The illumination homogeneity and treatment tip transmission were evaluated against defined technical limits.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not employ an AI/ML algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, long term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction. The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser. The LinScan System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan System. Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

The provided document, K141063 does not contain information on testing results that demonstrate the device meets acceptance criteria. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Key observations:

• No Acceptance Criteria Table: The document does not include a table outlining specific acceptance criteria for device performance.
• No Reported Device Performance: While the document lists device specifications (e.g., fluence, pulse widths, wavelength), it does not present performance data from a study to show how the device actually performed against any predefined acceptance criteria.
• Focus on Substantial Equivalence: The "Performance Data" section ([4] K141063, H. Performance Data) exclusively mentions adherence to IEC standards (IEC 60825-1 and IEC 60601-2-22) for electrical and laser safety, which are general safety and performance standards for laser products, not specific clinical or technical performance acceptance criteria for hair reduction.
• No Clinical Study Details: There is no mention of a human clinical study, sample sizes, data provenance, ground truth establishment methods, or expert involvement for evaluating the device's efficacy in hair removal or permanent hair reduction. The indications for use mention "stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime," which implies a need for clinical data to substantiate, but such data is not provided in this summary.

Therefore, many parts of your request cannot be fulfilled based on the provided input.

However, I can provide a general understanding of what such a table would look like and address the limited information available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the provided document does not include specific acceptance criteria or performance data for hair removal/reduction efficacy. If it did, a table might look something like this (hypothetical example):

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