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Intended Use: PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures.

Indications for Use:

PRIMELASE Excellence System with 810nm Laser applicator is intended for:

· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

• · Treatment of Pseudofolliculitis barbae (PFB).
• · Use on all skin types (Fitzpatrick I-VI).
• · Treatment of benign pigmented lesions

PRIMELASE Excellence System with 755nm Laser applicator is intended for:

· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

• · Treatment of Pseudofolliculitis barbae (PFB).
• · Use on all skin types (Fitzpatrick I-VI).
• · Treatment of benign pigmented lesions

PRIMELASE Excellence System with 1060nm Laser applicator is intended for:

· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

• Treatment of Pseudofolliculitis barbae (PFB).
• · Use on all skin types (Fitzpatrick I-VI).

· Treatment of benign vascular lesions, including angiomas, telangiectasia, and other benign vascular lesions and leg veins.

• Treatment of wrinkles
  PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for:

· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

• Treatment of Pseudofolliculitis barbae (PFB).
  · Use on all skin types (Fitzpatrick I-VI).

PRIMELASE Excellence is a diode laser device which consists of a central unit and external applicators.

The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 nm to 1060 nm, typically and most used 810 nm.), pulsed through the laser aperture situated at the tip of the applicator.

The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit.

The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment.

The provided text does not contain information about acceptance criteria and a study that proves the device meets them in the format requested.

The document is a 510(k) premarket notification for the "Primelase Excellence" laser device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting acceptance criteria and a study proving their fulfillment as typically seen for novel devices or significant modifications.

Here's a breakdown of why the requested information is not available in the provided text:

• Acceptance Criteria and Reported Device Performance Table: The document provides a "Comparison of Technological Characteristics" table (Table 2) comparing the subject device to predicate devices. This table lists technical specifications (e.g., wavelength, spot size, fluence) but does not present specific acceptance criteria (e.g., a minimum percentage of hair reduction) or reported device performance against such criteria. Instead, it aims to show the subject device's specifications are comparable to those of already cleared devices.

• Sample Size, Data Provenance, Expert Qualifications, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, and Training Set Ground Truth: All these items are related to a clinical study and its methodology. The document explicitly states: "No clinical study is included in this submission." Therefore, none of this information is present. The substantial equivalence argument relies on the similarity of the device's technological characteristics and intended use to predicate devices for which efficacy and safety were established.

In summary, the document demonstrates substantial equivalence through technical comparisons and adherence to recognized standards for safety and performance (non-clinical testing), rather than through a dedicated clinical study with specific acceptance criteria and performance metrics.

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Indications for use for PRIMELASE diode laser hair removal system with 755mm, 810mm and 810 - 1060mm applicators include:

· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

• Treatment of Pseudofolliculitis barbae (PFB).

· Use on all skin types (Fitzpatrick I-VI).

PRIMELASE diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consist in the specific destruction of a follicle due to an increase of the temperature induced by a high-powered beam of light which is selectively absorbed by the melanin.

The PRIMELASE machine consists of a central unit and a set of 5 removable applicators. The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 mm to 1060 nm, typically and most used 810 nm.), pulsed through the laser aperture situated at the tip of the applicator.

The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle. The treatment can be provided in two modes, dynamic and static. Dynamic mode uses the low fluence & high frequency and is used for initial treatments. Static mode uses high fluence & low frequency and is used for residual hair removal.

The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment

This document is an FDA 510(k) clearance letter and related submission materials for the PRIMELASE diode laser hair removal system. The information provided in it does not describe a study that proves the device meets specific performance acceptance criteria for an AI/ML powered device, especially not those involving diagnostic accuracy or human interpretation. Instead, it demonstrates substantial equivalence to predicate laser hair removal devices based on technical specifications and safety standards.

Therefore, I cannot extract the information required for your request, as the provided text does not contain:

1. A table of acceptance criteria and reported device performance (in the context of an AI/ML study).
2. Sample size used for a test set or data provenance for an AI/ML study.
3. Number of experts used to establish ground truth or their qualifications for an AI/ML study.
4. Adjudication method for a test set for an AI/ML study.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study for an AI/ML device.
6. Information about standalone performance of an algorithm without human-in-the-loop.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML study.
8. Sample size for a training set for an AI/ML study.
9. How the ground truth for a training set was established for an AI/ML study.

The document explicitly states: "No clinical study is included in this submission." (Page 6, Section 5.7 Clinical Test Conclusion). The "Non-Clinical Test Conclusion" (Page 6, Section 5.6) refers to compliance with general electrical, safety, software, and biological standards (e.g., IEC 60601-1, IEC 62304, ISO 14971, ISO 10993) relevant to medical devices, not performance acceptance criteria for an AI/ML algorithm or its impact on human performance. The "Substantially Equivalence (SE) Comparison" (Page 7) compares technical specifications to predicate devices to demonstrate equivalence for FDA clearance.

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