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The Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: Removal of unwanted hair from all skin types (640nm to 1200nm); Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (510nm to 1200nm); Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins(485 nm to 1200nm); and Treatment of benign cutaneous lesions including warts, scars and striae (420nm to 1200nm). The Medicam Evolase pulsed light system (and included accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (1064nm to 1200nm); and Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins (532nm to 1200nm). The devices are intended for prescription use.

Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems emit intense wide spectrum emission with wavelength of 420 - 1200 nm. It includes the following main components: A system console (including software and electronic control boards); A control and color touch screen; and Hand piece with cooling system.

The provided document is a 510(k) summary for the Medicam Evolux, Evostar, Evolight, and Evolase Pulsed Light Systems. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) cannot be directly extracted from this document as it does not contain such detailed study information.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific numerical acceptance criteria or reported device performance metrics in the way that would typically be found in a clinical study report. The substantial equivalence argument relies on the device having the "same indications for use, similar design and functional features" as the predicate devices, implying that their performance is expected to be comparable.

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

Not applicable. The document does not describe a clinical study with a test set. This submission is based on substantial equivalence to predicate devices, referencing their established safety and effectiveness.

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

Not applicable. No new clinical study data with ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No new clinical study data is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission focuses on substantial equivalence based on indications for use and technological features.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a pulsed light system, not an algorithm. Performance is assessed through its physical characteristics and intended use, primarily compared to predicate devices.

7. The Type of Ground Truth Used

Not applicable. The submission is based on substantial equivalence, implying the "ground truth" for its safety and effectiveness is derived from the established history and performance of the predicate devices for their stated indications.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is a medical device, not an algorithm requiring a training set.

Summary of Substantial Equivalence Claim (as per document):

The document asserts that the Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems are substantially equivalent to the legally marketed predicate devices (Profile BBL System K032460 and Quantum, Models SR, HR, DL K020839).

The basis for this claim is:

• Indications for Use: The devices share the "same indications for use" as the predicate systems.
• Design and Features: They have "similar design and functional features."
• Technological Equivalence: "Technologically, the Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems are substantially equivalent to the listed predicate devices."

Therefore, the conclusion states: "the risks and benefits for Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System are comparable to the predicate devices." The acceptance criteria, in this context, are met by demonstrating this substantial equivalence to already cleared devices. No new, independent performance study with explicit numerical acceptance criteria is detailed in this 510(k) summary.

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