(80 days)
The Revolix laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialities including: Urology, Gasteroenterlogy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The RevoLix diode pump solid state is a surgical laser system operating at a wavelength of 2.0 micron. The purpose of the laser is the ablation, coagulation, and hemostasis of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via a fiber optic delivery system and this is guided by a handpiece or endoscopic surgical instrument. It consists of Laser Console with Internal Computer Control Panel and Display, A fiber optic delivery system, Footswitch.
The provided text is a 510(k) Summary for the RevoLix Family of Laser Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the manner you've described for AI/diagnostic devices. For laser systems, substantial equivalence is typically established based on similar intended use, technological characteristics, and safety profiles.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided document.
The document states:
- Rationale for Substantial Equivalence: The RevoLix laser system shares "intended use, indications for use, similar design features and functional features" with the predicate devices.
- Conclusion: The RevoLix Laser System was found to be "substantially equivalent" to the predicate surgical laser systems.
This type of submission focuses on regulatory comparison, not on detailed performance validation with specific acceptance criteria and study designs as would be expected for a software-as-a-medical-device (SaMD) or AI-based diagnostic tool.
§ 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.