(77 days)
The Erchonia Zerona-AD is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms.
Not Found
Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study that proves the device meets those criteria:
The provided document is an FDA 510(k) clearance letter for the Erchonia Zerona-AD device. This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed study results or acceptance criteria from a specific clinical trial conducted by the applicant. Typically, the 510(k) submission would include such studies, but the clearance letter itself only summarizes the regulatory decision.
Based solely on the provided text, the following information can be extracted, and significant gaps remain for the questions asked:
Acceptance Criteria and Device Performance (Based on the limited information):
- Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" for the FDA in this context is that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The performance of the 'Erchonia Zerona-AD' device is not directly quantified or compared to specific numerical acceptance criteria within this letter beyond meeting the substantial equivalence threshold to its predicate.
- Reported Device Performance: The letter states the device is "indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms." This is an indication for use, not a quantifiable performance metric or a result from a study presented in this document.
Detailed Breakdown of Questions:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria (Explicitly stated in this document) Reported Device Performance (Explicitly stated in this document) Substantial Equivalence to legally marketed predicate devices for the stated Indications for Use. "indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms." Note: The document confirms the device met the criteria for substantial equivalence, but it does not specify the performance metrics or thresholds for that equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. The 510(k) clearance letter does not include details on the specific clinical studies performed, their sample sizes, or data provenance. This information would be found in the 510(k) submission dossier itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided in the document. This information is related to the specific studies (if any) conducted on the device, which are not detailed in this clearance letter.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document. Similar to point 3, this refers to details of specific clinical studies not present in this letter.
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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
- Not applicable / Not provided. The device is a "Low level laser system for aesthetic use" (Erchonia Zerona-AD) and is described as a dermatological aesthetic treatment. It is not an AI-assisted diagnostic or imaging interpretation device, so an MRMC study with human readers improving with AI assistance would not be relevant in this context.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. As it's a physical laser device for aesthetic treatment, the concept of "algorithm only standalone performance" is not relevant here. The device's performance is intrinsically linked to its application by a human as a medical treatment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided in the document. The type of ground truth used would depend on the specific clinical studies conducted (e.g., changes in circumference measurements, patient satisfaction surveys, etc.), which are not detailed in this clearance letter.
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The sample size for the training set
- Not applicable / Not provided. This device is a physical medical device (laser system), not a machine learning or AI algorithm that requires a "training set" in the computational sense.
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How the ground truth for the training set was established
- Not applicable / Not provided. Similar to point 8, this question pertains to machine learning model development, which is not relevant for this type of device.
Conclusion:
The provided FDA 510(k) clearance letter confirms the regulatory status of the Erchonia Zerona-AD device based on its substantial equivalence to a predicate device. However, it does not contain the detailed study results, specific performance metrics, sample sizes, ground truth methodologies, or expert qualifications that would answer most of the questions posed. Such information would be found in the 510(k) submission document itself, which is not provided here.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Erchonia Corporation % Regulatory Insight, Incorporated Mr. Kevin Walls Principal Consultant 5401 South Cottonwood Court Greenwood Village, Colorado 80121
AUG 2 3 2012
Re: K121690
Trade/Device Name: Erchonia Zerona-AD Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: OLI Dated: July 20, 2012 Received: July 24, 2012
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Kevin Walls
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121690
Device Name: Erchonia Zerona-AD
Indications for Use: The Erchonia Zerona-AD is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms.
Prescription Use × (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)
(División Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
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510(k) Number 1/2/690
510(k) Num
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.