(57 days)
The DioSculpt laser system is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.
The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.
The provided text describes the 510(k) premarket notification for the DioSculpt laser system, which is intended for non-invasive lipolysis. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical outcomes.
The document focuses on demonstrating substantial equivalence to predicate devices through:
- Technological characteristics comparison: Showing similar technology, wavelength, pulse width, cooling, and patient attachment methods.
- Non-clinical testing: Biocompatibility, electrical safety, EMC, and performance testing (specifically temperature testing to ensure safety despite slightly higher energy density/peak power).
- Software verification and validation.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth used for clinical efficacy or diagnostic accuracy. These types of studies are not typically part of a 510(k) submission that relies on demonstrating substantial equivalence to a legally marketed predicate device through technological similarity and non-clinical safety/performance.
The only "performance" discussed is related to safety (temperature testing) and compliance with electrical and laser safety standards.
What can be extracted from the text related to performance/safety criteria are:
1. A table of acceptance criteria and the reported device performance (focused on safety performance):
| Acceptance Criterion (Safety) | Reported Device Performance (DioSculpt) |
|---|---|
| Maximum allowable temperature of applicators | All testing results do not exceed maximum allowable temperature of 41°C (Worst-case and real operation scenarios) |
| Biocompatibility | Complies with ISO 10993-1 for skin sensitization, in vitro cytotoxicity, and intracutaneous reactivity. |
| Electrical Safety | Complies with AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 standard. |
| Laser Performance | Complies with IEC60601-2-22:2019 and IEC 60825-1:2014. |
| Software Safety Level | "Moderate" level of concern (failure could directly result in minor injury). Software verified and validated. |
The remaining requested information is not available in the provided document:
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission which focuses on non-clinical testing and substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the safety tests, the "ground truth" is compliance with established international standards and the measured physical properties (e.g., temperature).
- The sample size for the training set: Not applicable (no machine learning model for training).
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the non-clinical testing performed to demonstrate the safety and performance (in a technical compliance sense, not clinical efficacy) of the DioSculpt device for its 510(k) clearance, asserting substantial equivalence to predicate devices. It does not contain information on clinical studies that establish efficacy acceptance criteria or clinical performance outcomes.
§ 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.