(82 days)
LGO-Surgical Laser Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified laser with operational wavelengths between 500 nm - 2200 nm equipped with SMA 905 standard or freestanding ferrule connector, as per the indications of the laser device used with.
LGO-Surgical Laser Fibers are a group of single use or reusable with up to 10 total uses EtO sterilized laser powered surgical instruments. They are intended for use in healthcare facilities or hospitals by physicians being familiar with the handling of medical laser devices, and with the therapeutic application of sterile medical optical fibers.
There are two primary product subgroups: Bare Fiber and Side Fire Fiber. Each subgroup encompasses various models on the market, which primarily vary in their distal end design, jacket materials, diameter, length, and usage (single use or 10x reusable). All variations of the LGO-Surgical Laser Fibers feature an SMA-905 connector or a custom special connector at the proximal end for compatibility with appropriate medical laser devices.
The provided FDA 510(k) summary for the LGO-Surgical Laser Fibers describes a medical device (laser fibers), not an AI/Software as a Medical Device (SaMD). Therefore, the document does not contain the information requested regarding acceptance criteria, study details, human reader studies, or ground truth establishment for AI/SaMD.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: This includes product code, indications for use, core diameter, material composition, operating wavelength, usage, sterilization, and proximal end connector.
- Non-clinical performance data: This section lists various tests performed on the device to ensure its safety and performance (e.g., biocompatibility, sterilization validation, shelf-life validation, light transmission, functional tests).
- A statement that no clinical testing was performed or deemed necessary.
In summary, none of the requested information regarding acceptance criteria and study proving an AI/software device meets these criteria can be extracted from this document, as it pertains to a physical medical device (laser fibers) and not AI/SaMD.
Therefore, I cannot populate the table or provide answers to the questions based on the provided text.
§ 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.