(174 days)
Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.
The Waterlase MD dental laser system is a device used to perform a variety of dental soft and hard tissue indications. For hard tissue procedures the Waterlase MD uses the Erbium,Chromium:Yttrium,Scandium,Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, shave, contour, roughen and etch tissues. Soft tissue procedures are performed using two different modes of operation. H and S. where direct Er.Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration. cooling or to keep tissues and the field of view clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues and field of view clean.
A flexible fiber optic terminated into the handpiece delivers the Waterlase®MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a regulatory filing for an expanded indication for use of the Waterlase MD dental laser system, establishing its substantial equivalency to previously cleared devices.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, study design, sample sizes, expert involvement, or ground truth.
The document discusses the device description, indications for use, contraindications, and regulatory information, but it does not include data from a clinical trial or performance study that would typically involve acceptance criteria. The basis for clearance is "Substantial Equivalence" to another device, meaning it's assumed to perform similarly to an already approved device without necessarily requiring new performance studies against specific acceptance criteria.
§ 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.