(90 days)
Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications. A complete list is contained in the Indications for Use Statement.
Ophthalmology: Retinal Photocoagulation, Trabeculoplasty, Iridotomy, Diabetic retinopathy, Peripheral Iridectomy, Posterior and Anterior procedures, Senile macular degeneration.
Ear, Nose and Throat (ENT): Stapedectomy, Stapedotomy, Myringotomies, Lysis of Adhesions, Control of Bleeding, Removal of Acoustic Neuromas, Soft Tissue Adhesion in Micro/Macro Otologic Procedures.
Dermatology: Pigmented lesions, including soar lentgine, Vascular lesions, including cherry hemangiomas and angiokeratomas, Extremeties telangiectasias, including facial and leg telangiectasias, Cutaneous lesions, Flat warts, Dermatosis Papulosa Nigra.
Dentistry: Frenectomy, Treatment of Oral Mucous Cyst, Treatment of Benign Vascular Lesions: Capillary hemangioma, Hemorrhagic hereditary telangiectasia, Capillary/cavernous hemangiomas, Lymphangioma, AV malformation of the tongue, Hemangiolymphangiomas, Photocoagulation of superficial vessels, Vaporization of superficial blood or lymph containing vessels, Treatment of superficial tongue lesions, Tissue management and hemostasis for crown and bridge impressions, Incision and drainage for abscess, Gingivoplasty/ gingivectomy, Operative procedures, Crown and bridge, gingival reduction, Crown lengthening, Hyperplasia (Drug, Irritation, Epulus, ... ), Hemostasis during dental procedures, Operculectomy (Operculotomy), Excisional biopsy, Free Ginvical Graft (Adjunct): Hemostasis of donor site, Hemostasis of graft site, Vestibuloplasty, Soften Gutta Percha, Treatment of canker sores, herpetic lesions, and aphthous ulcers, Laser-assisted bleaching/whitening.
The Novus Spectra solid state, frequency-doubled, green Nd:YAG surgical laser system is an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. Compatible delivery devices include: slit lamps, slit lamp adapters/attachments, laser indirect ophthalmoscopes (LIO), microfilters, collimated handpieces with spot sizes ranging from 200-1200microns, fibers and endocular and endooto probes.
This document is a 510(k) summary statement for the Lumenis Novus Spectra Laser System, seeking substantial equivalence to predicate devices (Elite and Corium laser systems). It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from the provided text.
Here is a summary of what can be extracted or inferred based on the nature of a 510(k) submission:
1. A table of Acceptance Criteria and the Reported Device Performance:
- This information is not provided in the document. 510(k) submissions for substantial equivalence generally focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance targets in the same way a de novo or PMA submission might. The document states the Novus Spectra Laser System "has the same indications for use as the Elite family of lasers and the Corium series of lasers. They have similar functional elements such as treatment wavelengths, pulse rates, treatment power, spot size and cooling system."
Further requested information which is not available in the provided text:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
Key takeaway: This document represents a regulatory submission for substantial equivalence based on similarity to existing devices, not a study demonstrating a novel device's performance against predefined acceptance criteria for a specific clinical task. The focus is on showing the new device has "similar functional elements" and "same indications for use" as its predicates.
§ 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.