(76 days)
The PowerLipo Laser System is indicated for use the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The PowerLipo is further indicated for laser assisted lipolysis.
The PowerLipo Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the heart of the PowerLipo Laser System and contains the Nd-YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the FND display.
This document is a 510(k) Summary for the Lutronic Corporation PowerLipo Laser System, submitted to the FDA in 2008. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document because it explicitly states:
"6. Performance Data: None presented."
This indicates that a study demonstrating the device's performance against specific acceptance criteria, as one might find for a novel device or a device requiring clinical trials, was not included or required for this 510(k) submission.
Here's a breakdown of what can be inferred or directly stated based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document explicitly states "Performance Data: None presented." This implies that specific acceptance criteria and a study demonstrating the device's performance against those criteria were not part of this 510(k) submission. The FDA clearance was based on substantial equivalence to predicate devices, not on a new performance study for this specific device.
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. No test set or corresponding data is described because no performance data was presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No test set or ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. 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 system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a laser system, not an algorithm. Standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable. No ground truth for performance evaluation is described.
8. The Sample Size for the Training Set
Not applicable. This device is a laser system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set or ground truth establishment is relevant for this type of device and submission.
In summary, the 510(k) Summary explicitly states "Performance Data: None presented," meaning the requested information regarding performance criteria and studies is not contained within this document. The clearance for the PowerLipo Laser System was based on its substantial equivalence to existing legally marketed predicate devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.