(213 days)
Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.
Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision. tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
The Waterlase®MD Derm medical laser system is a device used to perform a variety of soft tissue indications. Soft tissue procedures are performed using a different mode of operation 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.
fiber optic terminated into the handpiece delivers flexible ব the Waterlase®MD Derm 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 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.
I am sorry, but the provided text is a 510(k) Summary for a medical device (Waterlase® MD Derm, K071734), which is a laser surgical instrument. This document describes the device, its indications for use, and its substantial equivalence to predicate devices based on regulatory clearance.
This type of document does not include information about:
- Acceptance criteria and reported device performance metrics in a table. The 510(k) process focuses on demonstrating substantial equivalence, not on detailed performance studies with acceptance criteria like those for diagnostic devices that would report sensitivity, specificity, or accuracy.
- Sample size used for the test set or data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with/without AI.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
These details are typically found in performance studies for diagnostic or AI-powered devices, which require demonstrating specific performance characteristics. The Waterlase® MD Derm is a surgical tool, and its clearance is based on its similarity to existing cleared surgical lasers, not on a data-driven performance study in the way an AI diagnostic device would be evaluated.
Therefore, I cannot fulfill your request for this specific document as the information is not present.
§ 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.