(48 days)
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:
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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.
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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.
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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.
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Adjudication Method: Similar to the above, this would be described in the study's methods.
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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.
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Standalone Performance: The 510(k) clearance focuses on substantial equivalence. If standalone performance data was generated, it would be in a study report.
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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.
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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.
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked vertically.
MAY - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Erchonia Medical, Inc. C/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127
Re: K050672
Trade/Device Name: Erchonia EVRL Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: April 13, 2005 Received: April 14, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are cance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costicule Hot (110-) that to novice, subject to the general controls provisions of the Act. The 1 ou may, mercrore, mailies of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (discuss controls. Existing major regulations affecting your device it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oououncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualite or woulder with other requirements of the Act that I DA has made a dolorimistered by other Federal agencies. You must or any rederal statutes and regulations and inding, but not limited to: registration and listing (2 l comply with an the Act 31equirements) 11 CFR Part 801); good manufacturing practice requirements as set CFR Fart 807), adeling (21 CFR Part 820); and If applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kevin Walls, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogin manetally your antial equivalence of your device to a legally premits in the results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac note the regulation of the regulation entitled, Colliact the Office of Compulation in (21CFR Part 807.97). You may obtain Misolanding by release to promanto no nomanto new the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
.Enclosure
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Indications for Use
510(k) Number (if known): K050672
Device Name: Erchonia EVRL Laser
Indications for Use: 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.
ﯿﮟ
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restorative
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.