(85 days)
The Erchonia® SHL Laser is indicated for use as a non-invasive dermatological aesthetic treatment for reduction of circumference of hips, waist and upper abdomen when applied to individuals with a Body Mass Index (BMI) between 30 kg/m² and 40 kg/m².
Not Found
This document is a 510(k) clearance letter from the FDA for the Erchonia® SHL Laser. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial report would. It only confirms the device is substantially equivalent to a predicate device for its indicated use.
Therefore, most of the requested information cannot be extracted from the provided text.
However, I can extract the "Indications for Use" which defines for what purpose the device is intended.
Indications for Use: The Erchonia® SHL Laser is indicated for use as a non-invasive dermatological aesthetic treatment for reduction of circumference of hips, waist and upper abdomen when applied to individuals with a Body Mass Index (BMI) between 30 kg/m² and 40 kg/m².
Regarding the requested information, here's what can be stated based only on the provided text:
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A table of acceptance criteria and the reported device performance:
- No acceptance criteria or reported device performance are mentioned in this administrative document. The 510(k) clearance is based on substantial equivalence, not a direct clinical performance study detailed here.
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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 present in this document.
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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 present in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present in this document.
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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 present in this document. This device is a laser system, not an AI diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not present in this document. This device is a laser system, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not present in this document. Substantial equivalence relies on comparison to a predicate device, not necessarily a new ground truth determination in the context of this clearance.
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The sample size for the training set:
- Not present in this document. This is not an AI/algorithm device that requires a training set in the typical sense.
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How the ground truth for the training set was established:
- Not present in this document.
§ 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.