(129 days)
The LightScalpel LS-1005 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, podiatry, and urology.
Dental Procedures:
Gingivectomy - Removal of hyperplasias; Gingivoplasty; Papillectomy; Vestibuloplasty; Epulis: Sulcular Debridement; Removal of soft tissue, cysts, and fibroma (non-malignant turnor, mucosa, tongue); Extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; A heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium).
Oral Surgery Procedures:
Frenum Release/Frenectomy; Drainage (abscess); Flap Surgery; Biopsy (incisional & excisional); Aphthous Ulcers (incision & excision); Incision of Infection when used with antibiotic therapy; Excision & Ablation of lesions, benign & malignant lesions, oral cavity turnors, and hemangiomas; Salivary Gland Pathologies; Preprosthetic Gum Preparation, Leukoplakia; Partial Glossectomy; Periodontial Gum Resection; Homeostasis; Operculectorny; Crown Lengthening (soft tissue).
The LightScalpel LS-1005 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.
The provided document is a 510(k) summary for the LightScalpel LS-1005 CO2 Laser System. This type of document is a premarket notification for new medical devices, demonstrating substantial equivalence to a legally marketed predicate device. It primarily focuses on comparing the new device's technological characteristics and intended use to existing, cleared devices.
As such, the provided text does not include information about acceptance criteria for device performance in the context of clinical or standalone studies using AI. It describes the device's technical specifications and safety standards, but not performance metrics like sensitivity, specificity, or accuracy that would typically be evaluated in a study demonstrating how well a device meets specific acceptance criteria that are relevant to an image-based AI medical device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC/standalone studies, as these aspects are not part of this 510(k) submission.
The document states:
- "Device performance evaluation did not involve Animal of Clinical Testing." (Page 4, Section 9)
- "The LightScalpel LS-10 CO2 Laser System has been evaluated for performance equivalent to predicate devices through a combination of (1) verification and validation tests per product requirements and specifications and (2) inspections and tests derived from applicable regulations and safety standards as noted below." (Page 4, Section 8)
This means the evaluation for this medical device primarily focused on meeting engineering and safety standards, and demonstrating substantial equivalence to existing devices through characteristic comparison, rather than through clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy or similar metrics.
§ 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.