(86 days)
The Powersculp 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.
The Powersculp laser lipolysis system is a diode laser system. Electrically efficient semiconductors generate optical radiation (1060 mm) which is used to deliver laser energy to subcutaneous tissue layers. The Powersculp laser lipolysis system is capable of peak powers of 50W. The main components of Powersculp laser lipolysis system are a console and four applicators.
The provided text describes a 510(k) premarket notification for the "Powersculp laser lipolysis system" and primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for de novo performance validation as one might see for an AI/ML device.
Therefore, the document does not contain the specific information required to answer questions 1-9 comprehensively for a device proving it meets acceptance criteria through clinical studies. The submission explicitly states that clinical tests were not performed for the Powersculp given its substantial equivalence to already marketed devices.
However, I can extract information related to the device's technical specifications and how the manufacturer states the device meets safety and effectiveness requirements by relying on existing predicate devices and non-clinical testing.
Here's a breakdown of what can be inferred or directly stated from the document, and where information is explicitly lacking for the prompt's requirements:
Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" to Predicates)
Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence (SE) to legally marketed predicate devices. The performance is not measured against explicit clinical thresholds in this document, but rather by showing comparable technology and safety.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) based on substantial equivalence, there are no specific performance acceptance criteria like sensitivity, specificity, or accuracy for a diagnostic AI. Instead, the acceptance is based on demonstrating the proposed device is as safe and effective as the predicates. The "performance" is implicitly tied to the general performance of the predicate devices.
The table below summarizes the comparative attributes that, when deemed "similar" or "same" to the predicate, imply acceptance for a 510(k) submission.
| Attribute/Criterion (Implied for SE) | Powersculp Laser Lipolysis System (Proposed Device) | Predicate Devices (K160470 & K150230 SculpSure) | Comparison/Outcome |
|---|---|---|---|
| Indications for Use | Non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells for aesthetic affect (BMI |
§ 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.