(186 days)
The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:
Ophthalmology
Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)
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 lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases 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 Hermaniolymphangiomas 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 subject Lumenis® Smart532™ Laser System product is a dual port, solid state, frequency doubled, green Nd:GdVO4 surgical laser instrument used in the photothermolysis (photocoagulation) of soft tissue at an operating emission wavelength of 532nm, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry.
Compatible delivery devices & accessories for use with the subject Lumenis® Smart532™ Laser System include: Slit lamps, Slit lamp adapters/attachments, Laser Indirect Ophthalmoscopes (LIO), Eye safety filters, Laser links, Array LaserLink, Selecta Trio, Fibers and Endo-ocular and Endo-Oto probes. The device software may be adjusted by Lumenis to fit customer needs within the system overall range of parameters.
This document is a 510(k) summary for the Lumenis® Smart532™ Laser System, seeking clearance from the FDA. It declares substantial equivalence to predicate devices, focusing on technical specifications rather than clinical study results demonstrating diagnostic or treatment accuracy. Therefore, information regarding acceptance criteria, study sample sizes (for test and training sets), expert consensus, ground truth establishment, MRMC studies, or standalone algorithm performance, which are typical for AI/ML device submissions, is not present in this document.
The document discusses performance data in a general sense, referring to engineering performance testing (electrical safety, EMC requirements, functional testing) to ensure the device meets design specifications and is substantially equivalent to predicates. It does not refer to clinical performance in terms of diagnostic effectiveness or AI accuracy metrics.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has "equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, patient population, and general modes of operation."
- Reported Device Performance:
- The document states that "Appropriate testing for the subject Smart532™ Laser System device, including safety, performance and functional testing, has been performed to determine substantial equivalence..."
- Specifically, "electrical safety & EMC requirements per governing IEC 60601 3"-Edition Series, and side-by-side comparative performance assessment to the identified primary predicate Lumenis® Novus Spectra™ Laser System (K022327)" were performed.
- It concludes that "all established testing criteria and product performance specifications have been met."
- The "Device Comparison Table" on page 7 implicitly serves as a performance comparison, showing that key characteristics (wavelength, aiming beam, laser type, power input/output, operating mode, pulse duration, pulse/exposure interval) are either identical or similar with explanations for differences (e.g., SmartPulse vs. MicroPulse). However, this table does not present "acceptance criteria" in the traditional sense of numerical thresholds for clinical accuracy (e.g., sensitivity, specificity). It's a technical comparison for substantial equivalence.
2. Sample sizes used for the test set and the data provenance:
- Not Applicable / Not Provided: This type of information (patient sample sizes for a test set) is typically relevant for studies validating diagnostic or predictive AI/ML algorithms. This submission is for a surgical laser system, and the "performance data" refers to engineering and functional testing, not clinical data from patient populations in the context of an AI test set. There's no mention of a "test set" in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: As in point 2, this is relevant for AI/ML validation. Ground truth for a surgical laser system's performance would relate to its physical outputs (power, pulse duration, wavelength) and safety features, measured by instruments and engineering standards, not expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: This is a method for resolving discrepancies in expert labeling of ground truth data, relevant for AI/ML studies.
5. 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:
- Not Applicable / Not Provided: This document does not describe an AI-assisted device. It describes a surgical laser. Therefore, MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: This pertains to AI/ML software. The device is a physical laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicit (Engineering Standards): The "ground truth" for this device's performance would be established through engineering measurements against industry standards (e.g., IEC 60601 for electrical safety and EMC) and comparison to the technical specifications of the predicate devices. It's not based on clinical outcomes or expert consensus on medical images.
8. The sample size for the training set:
- Not Applicable / Not Provided: This is for AI/ML models.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: This is for AI/ML models.
In summary, this document is a 510(k) premarket notification for a physical medical device (a surgical laser system), not an AI/ML diagnostic or therapeutic device. The "acceptance criteria" and "study" described are focused on demonstrating technical substantial equivalence to predicate devices and adherence to engineering safety and performance standards, rather than clinical performance metrics typically associated with AI/ML validation studies.
§ 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.