(27 days)
The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, abiation, raponiation, valuation, varian and tissue in use in medical specialites inoldung: Orelegy, Central Surgery, General Surgery.and Arthroscopy
The RevoLix and RevoLix Jr are diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument.
It consists of:
Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
This document is a 510(k) summary for the AllMed Systems Inc. RevoLix and RevoLix Jr laser systems. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
Instead, this submission is focused on demonstrating substantial equivalence to predicate devices already on the market, as required for a 510(k) premarket notification to the FDA. The rationale for substantial equivalence is stated as sharing the "same intended use, indications for use, similar design features and functional features" with the Lumenis VersaPulse Laser.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size regarding human reader improvement with AI assistance. (This device is a surgical laser, not an AI-assisted diagnostic tool).
- Whether a standalone performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as a regulatory submission for a medical device (surgical laser) and not a performance study report. The FDA's letter (pages 5-7) confirms the substantial equivalence determination but doesn't detail performance studies against specific acceptance criteria beyond typical safety and efficacy assessments inherent in medical device clearance.
§ 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.