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The Erasure laser is used for the treatment of benign vascular and vascular dependent lesions.

The Erasure Laser consists of three interconnected sections: the power supply, the water cooling system and the optical path.

The provided text is a 510(k) summary for the Cynosure Erasure Pulse Dye Laser. This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel device performance through extensive clinical studies. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies is largely not applicable to this specific document.

Here's an breakdown based on the information provided in the 510(k) summary:

• Acceptance Criteria and Reported Device Performance: This document does not describe specific performance-based acceptance criteria or report performance metrics from a study designed to meet such criteria. The basis for approval is substantial equivalence to a predicate device.

• Sample Size for Test Set and Data Provenance: Not applicable. No test set or clinical data was provided. The submission states "Clinical Performance Data: None."

• Number of Experts and Qualifications: Not applicable. No ground truth was established from experts for a test set.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. No such study was conducted or reported. The document explicitly states "Clinical Performance Data: None."

• Standalone (Algorithm Only) Performance Study: Not applicable. This is a laser device, not an algorithm.

• Type of Ground Truth Used: Not applicable. No ground truth was established for performance evaluation.

• Sample Size for Training Set: Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.

• How Ground Truth for Training Set Was Established: Not applicable.

Summary based on the provided 510(k) document:

The Cynosure Erasure Pulse Dye Laser was approved based on its substantial equivalence to the Cynosure PhotoGenica VLS Laser. The comparison was based on:

• Treatment wavelengths
• Pulse duration
• Pulse energy
• Biological effects

The 510(k) summary explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This means the manufacturer did not submit specific performance studies with acceptance criteria, sample sizes, or ground truth to demonstrate the device's efficacy or safety beyond the comparison to the predicate device. The FDA's review concluded that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to proceed to market under general controls.

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