(111 days)
The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
The CO2 Laser Machine generate a 10,600nm wavelength, which is absorbed by water in the tissue.
The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).
It looks like the provided FDA 510(k) Clearance Letter for the Lume CO2 Laser Machine primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to general safety and performance standards for laser devices.
It does not contain information about a study that proves the device meets acceptance criteria related to a specific clinical performance metric (like accuracy for an AI device).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided document.
The document discusses:
- Indications for Use: The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
- Technological Characteristics: This section compares the Lume's technical specifications (e.g., laser type, wavelength, power, spot size) to two predicate devices, arguing that differences do not negatively impact safety or effectiveness.
- Non-clinical Performance Tests: It lists compliance with various ISO and IEC standards related to electrical safety, electromagnetic compatibility, and laser safety.
- Biocompatibility: It mentions evaluation in accordance with ISO 10993 for cytotoxicity, skin sensitization, and irritation.
In summary, the provided text does not describe the kind of clinical or AI performance study you are asking about. It details how the device is considered substantially equivalent to existing laser devices, primarily through comparison of technical specifications and adherence to general safety standards.
If this were an AI/software device, the 510(k) submission would typically include a "Software Validation" section or a specific study demonstrating performance against a defined ground truth, with detailed acceptance criteria for metrics like sensitivity, specificity, or AUC. This document does not contain such details because it's for a physical CO2 laser machine.
§ 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.