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The Erchonia EVRL Laser is generally indicated:

• while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and
• b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Erchonia EVRL Laser

This is an incredibly difficult request, as the provided document is a 510(k) clearance letter from the FDA, not a study report or clinical trial results.

A 510(k) clearance signifies that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, essentially meaning it's as safe and effective as a device already on the market. It does not present the original study data, acceptance criteria, or performance metrics in the format requested.

Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and performance data for the Erchonia EVRL Laser from this specific document.

However, I can explain why I cannot provide the information from this document and what kind of document would contain it:

• Acceptance Criteria and Reported Device Performance (Table): This information would be found in a clinical study report submitted as part of the 510(k) application, or detailed within the substantial equivalence comparison to the predicate device. The clearance letter itself does not contain these details.

• Sample Size (Test Set) and Data Provenance: This would also be in the clinical study report. The 510(k) letter only indicates the clearance and the date it was received.

• Number and Qualifications of Experts for Ground Truth: This level of detail about ground truth establishment is specifically found within the methodology section of a clinical study report.

• Adjudication Method: Similar to the above, this would be described in the study's methods.

• MRMC Comparative Effectiveness Study: If such a study were performed, its design, methodology, and results (including effect size) would be elaborated in a separate study report. The 510(k) clearance letter does not include this. Given the device's indications, it's unlikely an MRMC study related to human readers would be highly relevant, as it's a laser for pain and acne, not an imaging diagnostic tool.

• Standalone Performance: The 510(k) clearance focuses on substantial equivalence. If standalone performance data was generated, it would be in a study report.

• Type of Ground Truth: The method for establishing ground truth (e.g., expert consensus, pathology, outcome data) would be detailed in the study report. For pain relief, ground truth might involve patient-reported pain scores or physician assessment. For acne, it might involve lesion counts or global assessment scales.

• Sample Size for Training Set: This is typically relevant for machine learning algorithms. While the Erchonia EVRL is a laser device (not explicitly an AI/ML device based on this document), if there were any AI components involved in its use or assessment, that data would be in an AI/ML specific technical report or a clinical study report.

• How Ground Truth for Training Set was Established: Again, this relates to AI/ML development and would be in a technical report or study protocol.

In summary, to answer your request comprehensively, I would need access to the full 510(k) submission, specifically the clinical study reports or summaries of the studies conducted to demonstrate substantial equivalence.

The provided document (K050672) is merely the FDA's decision letter.

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