Search Results

The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

The Emerge Fractional Laser consists of a fractional laser handpiece attached to a base unit. The base unit includes a power supply, control electronics, and user interface LCD screen.

This 510(k) summary (K111840) for the Emerge Fractional Laser does not contain a study that proves the device meets specific acceptance criteria with reported performance metrics.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence is established by comparing the technological characteristics, mechanism of action, intended use, and previously provided clinical and histology data (not detailed in this summary).

Therefore, I cannot populate the requested table and information points as they relate to a clear acceptance criteria study with defined performance. The provided document states that "the review of the technological characteristics, mechanism of action, indications for use, clinical data, histology data, and verification as well as validation information provided in the 510(k) Premarket Notification demonstrates that the Emerge Fractional Laser is substantially equivalent to its predicate device." This implies that data exists elsewhere in the complete 510(k) submission, but it is not included in this summary.

Based on the provided text, the following points cannot be addressed:

• 1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance results are listed in this summary.
• 2. Sample sized used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method: Not mentioned.
• 5. 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: This device is a laser system, not an AI-assisted diagnostic tool, so this question is not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a laser system.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described for the context of a performance study. Clinical and histology data are mentioned as having been provided elsewhere.
• 8. The sample size for the training set: Not mentioned.
• 9. How the ground truth for the training set was established: Not mentioned.

Ask a specific question about this device