(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.
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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.
§ 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.