(93 days)
The LipoAI is indicated for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.
The LipoAl is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin. The DEKA LipoAl device consists of: An AC/DC power supply unit, CPU controller, LASER source, Cooling system, User interface with LCD touch screen, Beam delivery system. Laser activation is controlled by footswitch. Electrical specifications are: 200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max)
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI-driven diagnostic devices.
The document describes a 510(k) premarket notification for a medical laser device, DEKA LipoAI. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (Lutronic AccuSculpt II Laser system), not to prove performance against specific acceptance criteria for an AI algorithm.
Here's a breakdown of why the requested information is absent and what is present:
- No AI-driven diagnostic or analytical capabilities: The DEKA LipoAI is a "Laser Surgical Instrument" for physical procedures like surgical incision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis. It does not appear to have any AI components that perform diagnosis, image analysis, or provide analytical outputs requiring performance metrics like sensitivity, specificity, or AUC. The "AI" in "LipoAI" might refer to "Artificial Intelligence" in a product branding sense, but its function as described is that of a laser delivery system, not an intelligent analytical tool requiring performance criteria to classify medical conditions.
- Focus on Substantial Equivalence: The document explicitly states the purpose is to "demonstrate substantial equivalence" to a predicate device. This process primarily involves comparing specifications, indications for use, and safety standards rather than proving novel performance capabilities of an AI system.
- Non-Clinical Performance Data: The "Non-Clinical Performance Data" section discusses:
- Electrical safety and electromagnetic compatibility (EMC): Tested against standards like ANSI AAMI ES60601-1 and IEC 60601-1-2.
- Software Validation and Verification Testing: Conducted "as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" This likely refers to the software controlling the laser's operation, not an AI for diagnosis.
- Additional non-clinical testing: Against standards like IEC 60601-2-22 and IEC 60825-1 (laser safety standards).
These are all engineering and safety compliance tests, not performance studies for an AI algorithm.
- "Clinical Performance Data: None": This explicitly states that no clinical performance data was provided for this submission. This further confirms that no studies were conducted to assess the diagnostic or analytical performance of an AI component, as such studies would be considered clinical performance.
Therefore, I cannot provide a table of acceptance criteria or details about an AI performance study because the provided document does not indicate the device has AI capabilities that would require such performance evaluation in the context of diagnostic accuracy.
The information requested would typically be found in a submission for an AI/ML-driven diagnostic medical device. This document details a laser surgical instrument, where the "AI" likely does not translate to diagnostic or analytical artificial intelligence.
§ 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.