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The Light Age Inc. EpiCare-YAG™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(k) and no clinical data is presented.

Specifically the 1064 nm wavelength is indicated for:

• Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin.
• Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
• Benign cutaneous lesions such as warts, scars, striae, and psoriasis
• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
• Pigmented lesion size reduction in patients with lesions who would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
• Treatment of pseudofolliculitis barbae (PFB).
• Treatment of wrinkles including but not limited to periocular wrinkles and perioral wrinkles.

The Light Age Inc. EpiCare-YAG™ Laser System is a Class IV laser surgical instrument for use in general medical / cosmetic procedures, general and plastic surgery and dermatology. Using neodymium YAG crystal rods, pulsed energy is emitted at 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the following components and accessories:

• 1. Laser source and onboard microprocessor based control unit
• 2. Laptop user interface
• 3. Flexible optical fiber and handpiece delivers energy from the laser to the target area via optical fiber with handpiece, which produces a circular beam on the skin.
• 4. Foot pedal switch activates delivery when lasers are enabled.

The provided text describes a laser system, the EpiCare-YAG™ Laser System (K113117), which is a modified version of a previously approved device, the EpiCare-DUO™ Laser System (K091625). The submission is for a design change where the Alexandrite 755nm modules were removed, resulting in a device that operates only at the 1064nm wavelength.

This is a 510(k) Premarket Notification whose primary purpose is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of a new, unproven device against specific acceptance criteria in a clinical setting.

Therefore, the structure of the provided information does not contain the typical elements of a clinical study that would establish specific performance metrics and acceptance criteria for a novel device. Instead, the "acceptance criteria" here relate to regulatory compliance and the demonstration of substantial equivalence.

Here's an interpretation based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating that the modified device is as safe and effective as its predicate devices, and that it conforms to relevant standards. Since no new clinical indications were sought, no new clinical data or specific performance metrics are presented in the traditional sense for a clinical trial.

Regarding the specific questions about a "study":

The provided text does not describe a clinical study in the way one would for a novel device proving clinical acceptance criteria. Instead, it describes a regulatory submission (510(k)) based on substantial equivalence. Therefore, many of the requested details about a study are not applicable or extractable from this document.

1. Sample size used for the test set and data provenance: Not applicable. No specific "test set" in the context of a performance study is mentioned. The submission relies on prior clinical experience with the predicate device family ("over 1 million treatments performed" with the EpiCare™ product family over "nearly one decade," although this isn't a "test set" for this device's performance).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No specific "ground truth" establishment by experts for a test set is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. This is a laser surgical instrument, not an AI-assisted diagnostic device with "human readers."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's acceptable performance is implied by the long-standing safe and effective use of the predicate device (EpiCare-DUO™) and its technology, and its conformity to established standards. No new clinical ground truth was established for this specific 510(k).
7. The sample size for the training set: Not applicable. No "training set" in the context of an algorithm or new device performance study is mentioned.
8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) application is a regulatory pathway for modifications to existing devices, asserting that the modified device is substantially equivalent to a legally marketed predicate device. It does not involve new clinical trials or the establishment of new performance-based acceptance criteria through an independent study for the EpiCare-YAG™ system. The "study" here is essentially the demonstration of regulatory compliance and the logical argument for substantial equivalence based on the predicate device's established safety and effectiveness.

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