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a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

The Erchonia® EVRL (Model# EVRL) is indicated for use:

a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.

The components of the device consist of:

An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 640 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.

The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW red and

The provided text describes a 510(k) premarket notification for the Erchonia® EVRL device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (the same model, K152196) and presents clinical data to support the device's expanded indication for use in relieving neck and shoulder pain.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission appear to be centered around demonstrating non-inferiority or superiority of the Erchonia® EVRL when using both red and violet diodes simultaneously for neck and shoulder pain, compared to the previously cleared red diode only application.

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The Erchonia® EVRL laser is generally indicated: a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Erchonia® EVRL laser

I apologize, but the provided text from the FDA 510(k) summary for the Erchonia EVRL laser does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria for medical imaging or AI applications.

The document is a letter from the FDA stating that the Erchonia EVRL laser is substantially equivalent to legally marketed predicate devices for its stated indications for use (temporary relief of minor chronic neck and shoulder pain, and treatment of moderate inflammatory Acne Vulgaris).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided text. The information points you requested (e.g., sample size, expert qualifications, MRMC study, ground truth) are relevant to the evaluation of AI/imaging devices, but are not present in this regulatory correspondence for a laser therapy device.

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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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