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The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:

• The treatment of moderate inflammatory acne vulgaris .
• The treatment of benign pigmented epidermal lesions . including dyschromia, hyper-pigmentation, melasma, ephelides (freckles)
• The treatment of cutaneous lesions including warts, scars, . and striae.
• The treatment of benign cutaneous vascular lesions, . including port wine stains, hemangiomas, facial, truncal and leq telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
• The removal of unwanted hair and to effect stable long-. term or permanent hair reduction.

The Chromolite™ is a Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Chromolite™ emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of 0.5Hz.

The provided text is a 510(k) summary for the Chromolite™ System, an Intense Pulsed Light (IPL) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria as might be seen for novel devices. Therefore, much of the requested information regarding detailed acceptance criteria and study designs is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria (e.g., specific percentages for improvement, reduction, or clearance) nor does it present a table of reported device performance metrics against such criteria. The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a predicate device through comparison of technological characteristics, intended use, and indications for use.

The "Performance Standards" section notes that the device complies with the European Medical Directive 93/42/EEC and will comply with voluntary standards UL60601-1:1996 for safety when marketed in the U.S. These are general safety and electrical standards, not performance criteria related to the clinical efficacy of the treatments.

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

The document does not describe a specific "test set" in the context of a clinical study with a defined sample size. The 510(k) summary is a regulatory submission, not a study report. It focuses on comparison to a predicate device and outlining general indications for use supported by the underlying technology (IPL).

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

There is no mention of a test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no such test set or adjudication process is described.

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

No MRMC comparative effectiveness study is mentioned. This device is an IPL system for various dermatological and cosmetic treatments, not a diagnostic imaging device where MRMC studies are typically conducted.

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

This is an IPL device operated by a human. There is no "algorithm only" or "AI" component described in this document for standalone performance evaluation.

7. Type of Ground Truth Used

Not applicable, as no specific clinical study data requiring ground truth is detailed in this 510(k) summary for the purpose of demonstrating efficacy beyond equivalence to a predicate device.

8. Sample Size for the Training Set

Not applicable. The document does not describe a training set in the context of an AI/ML model.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) process):

The provided document does not describe a specific clinical study with quantitative acceptance criteria and a detailed report of results against those criteria. Instead, it is a 510(k) Premarket Notification submission.

The "study" in this context is the company's demonstration that the Chromolite™ System is substantially equivalent to a legally marketed predicate device, the Orion lasers, Lovely system II (Harmony) (K033946).

The basis for proving this "acceptance" (i.e., substantial equivalence) is through:

• Comparison of Indications for Use: The Chromolite™ System shares the same or very similar aesthetic and cosmetic applications requiring selective photothermolysis, photocoagulation, or coagulation, and hemostasis of soft tissue as the predicate. The listed indications include treatment of:
  • Moderate inflammatory acne vulgaris
  • Benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, freckles)
  • Cutaneous lesions (warts, scars, striae)
  • Benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea erythema, angiomas, spider angiomas, poikiloderma of civatte, leg veins, venous malformations)
  • Unwanted hair removal and stable long-term or permanent hair reduction.
• Comparison of Technological Characteristics: The predatory device is also an Intense Pulsed Light (IPL) system. The Chromolite™ System utilizes xenon flashlamp technology, emits light at 390nm to 1200nm, via a 50mm x 15mm waveguide at a repetition rate of 0.5Hz. The document implies these characteristics are sufficiently similar to the predicate to establish equivalence regarding safety and effectiveness for the stated indications.
• Compliance with Safety Standards: The device states compliance with the European Medical Directive 93/42/EEC and voluntary safety standard UL60601-1:1996.

The conclusion of the 510(k) summary states: "The Chromolite system is substantially equivalent to its predicate device cited above, and raises no new safety and/or efficacy issues." The FDA's letter (K053324) confirms this substantial equivalence determination, allowing the device to be marketed.

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