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The Nd: Yag 1064 Laser is intended for:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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.
  The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
  The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign 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 wrinkles.
  The Nd:Yag 1064 Laser is intended for:
• Temporary increase of clear nail in patients with onychomycosis (e.g., derniatophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.)
  The Alexandrite 755 laser is intended for:
• Temporary hair reduction.
• Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.
  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. On all skin types (Fitzpatrick I - VI) including tanned skin.
• Treatment of benign pigmented lesions.
• Treatment of wrinkles.
• Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

The FAMILY OF SQUARE EPIL LASER , is a laser equipped with one or two solid-state laser sources:
As shown in the previous table, the 4 configurations of the Family differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm:
-Alex configuration has only one source and one wavelength available (755 nm).
-Alex configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available.
-Nd:Yag configuration has only one source and one wavelength available (1064 nm).
-In the Alex+Nd: Yag configuration has both the two wavelengths available (755 nm and 1064 nm) but can act only individually, simultaneous operations are not allowed.
This device is intended for medical use only.

This document, K161632, is a 510(k) premarket notification for a medical laser system called "FAMILY OF SQUARE EPIL." The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria through effectiveness studies. Therefore, much of the requested information regarding acceptance criteria, specific study designs, and quantitative performance metrics beyond safety and basic functionality is not available in this document.

Here's an attempt to answer your questions based on the provided text, with explicit notes where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise acceptance criteria for specific performance metrics (e.g., hair reduction percentages, lesion clearance rates) nor does it report quantitative device performance against such criteria. The device's performance is asserted through comparison to predicate devices and compliance with safety and electrical standards.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable or not specified. This document relates to a 510(k) submission for substantial equivalence based on technological characteristics and safety standards, rather than a clinical trial with a defined test set for efficacy.
• Data Provenance: Not applicable. The "tests" mentioned are primarily engineering and safety compliance tests, not clinical performance data from a specific patient cohort.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth, in the sense of clinical diagnostic accuracy or outcome evaluation, is not established as part of this submission for the new device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

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

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

• MRMC Study: No, an MRMC comparative effectiveness study was not described or performed according to this document. The submission focuses on substantial equivalence based on technical specifications and safety.
• Effect Size of Human Readers: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No, a standalone performance study in the sense of an algorithm's diagnostic or predictive accuracy was not performed. This device is a laser system, not an AI or algorithmic diagnostic tool.

7. Type of Ground Truth Used

• Type of Ground Truth: For safety and performance evaluations mentioned (biocompatibility, electrical safety, software, usability, pre-series tests), the "ground truth" is compliance with established engineering standards, regulatory requirements, and internal design control procedures. For the "clinical performance" related to its intended uses, the ground truth is implicitly defined by the well-established clinical outcomes associated with the predicate devices, which the new device is claimed to be substantially equivalent to. No new clinical outcome data or pathology reports are generated or evaluated for the purpose of this submission to establish novel ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no "training set" in that context. If referring to pre-series tests or design validation, the sample size or number of units tested is not specified but would be part of internal design validation.

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

• How Ground Truth for Training Set Was Established: Not applicable for the reasons stated above.

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