(105 days)
The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic assthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
The BodySculp is a diode laser system. The main components of BodySculp are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which issued to deliver laser energy to subcutaneous tissue layers.
The provided document is a 510(k) summary for the BodySculp device, which is a low-level laser system for aesthetic use. It details the device, its intended use, and a comparison to a legally marketed predicate device (PowerSculp) to demonstrate substantial equivalence.
However, the document explicitly states that "A human clinical study was not required as the device is identical to the predicate device." This means there isn't a study proving the device meets specific acceptance criteria for performance related to its intended aesthetic effect in the way you're asking, i.e., through a clinical trial with human subjects.
Instead, the acceptance criteria and performance data provided in this 510(k) are related to safety, electrical compatibility, and software validation, demonstrating that the device itself is safe and functions as intended, and is substantially equivalent to a device already cleared for market. The clinical effectiveness for aesthetic outcomes relies on the predicate device's prior clearance.
Therefore, for your specific request regarding acceptance criteria and performance related to the aesthetic claims of the device (disruption of adipocyte cells, aesthetic affect), the information is not available in this document because a clinical study for these outcomes was not performed for BodySculp.
Here's a breakdown of what is available in the document regarding "acceptance criteria" through non-clinical performance data:
Acceptance Criteria and Reported Device Performance (Non-Clinical)
Since a human clinical study for efficacy was not conducted for the BodySculp device, the "acceptance criteria" and "reported device performance" in this context refer to the non-clinical performance data supporting the device's safety and functional equivalence to the predicate.
| Acceptance Criteria Category | Specific Standards/Tests | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | IEC 60601-1 Test for Medical Electrical equipment: General Requirements for basic safety and essential performance | Performed: The test was performed. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility | Performed: The test was performed. |
| Laser Specific Safety & Performance | IEC 60601-2-22 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment | Performed: The test was performed. |
| Software Verification & Validation | Software Verification and Validation Testing for Moderate Level of Concern per FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices | Performed: The testing was performed per FDA guidance. |
| Biocompatibility | ISO 10993-1 Evaluation of medical device – Part 1: Evaluation and testing within a risk management process (specifically, evaluation of patient-contacting materials) | Not Required (Evaluation Conducted): An evaluation per ISO 10993-1 was conducted. It was determined that biocompatibility testing was not required because the materials and processes for the patient-contacting material are identical to the predicate device and had been previously cleared by the FDA. This indicates that the predicate's biocompatibility data serves as the "performance" for this device's materials. |
| Equivalence to Predicate Device (Indications) | The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less. | Identical: The indications for use are identical to the predicate device (PowerSculp). |
| Equivalence to Predicate Device (Technology) | Laser Type, Wavelength, Lipolysis method, Spot Size, Peak Power, Power Density, Pulse Width, Power Supply, Cooling mechanism. | Same/Similar: The BodySculp device has the same laser type (Diode Laser), wavelength (1060nm), lipolysis method (Heat-assisted), spot size (4x8 cm²), peak power (50W per applicator), power density (0.7-1.7W/cm²), pulse width (CW), power supply (AC100-240V/50-60Hz), and cooling (Contact Cooling) as the predicate device. |
Study Details (Based on the provided document)
As previously stated, a human clinical study was not required or conducted for the BodySculp device itself, as per the FDA 510(k) summary, because it was deemed substantially equivalent to a predicate device already on the market. Therefore, most of the following points cannot be answered from this document.
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Sample size used for the test set and the data provenance: Not applicable, as no dedicated clinical test set was required or used for this device's 510(k) clearance for aesthetic efficacy. The "test set" in the document refers to the device itself being tested against electrical safety and software standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human subject clinical ground truth was established for this device. Ground truth for the non-clinical tests (e.g., electrical safety) is typically established by engineering standards and test procedures, not expert consensus on medical images or outcomes.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no human subject clinical test set requiring adjudication was used.
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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. This device is a laser lipolysis system, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm for diagnostic performance. Its "standalone" performance refers to its ability to meet engineering and safety standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance data, the "ground truth" implicitly used is compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, laser safety, and software development. For the intended use and technological characteristics, the "ground truth" for substantial equivalence is the predicate device's cleared status and specifications.
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The sample size for the training set: Not applicable. This device does not use an AI/machine learning model trained on data for its primary function.
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How the ground truth for the training set was established: Not applicable.
§ 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.