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The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).

The Smart LIO is indicated for use in the following photocoagulation procedures:

• Panretinal photocoagulation;
• Segmental peripheral photocoagulation;
• Retinopexy; and,
• Pediatric retinal repairs (under general anesthesia).

The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:

• Lumenis Novus Spectra Laser System;
• Lumenis Vision One Laser System; and
• Lumenis Smart532TM Laser System.

The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is used in conjunction with a compatible Lumenis ophthalmic laser systems. The LIO illuminates and magnifies the fundus image for observation, and when connected to a Lumenis ophthalmic laser system, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.

The Smart LIO is a wireless headset worn on the physician's head and is used to treat patients in a supine position or who could not otherwise be treated using a standard slit lamp delivery system.

The provided text describes the regulatory filing for a medical device (Smart Laser Indirect Ophthalmoscope) and includes a summary of its performance testing for substantial equivalence. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria, reported performance, sample sizes, expert qualifications, or ground truth establishment in the context of diagnostic accuracy or effectiveness.

The document focuses on demonstrating that the Smart LIO performs similarly to its predicate device and meets safety and performance standards for a laser delivery device. It does not describe a study to assess diagnostic performance with human readers or AI.

Therefore, I cannot populate the requested table and provide answers to questions 2 through 9 based on the provided text.

Here is why:

• No Acceptance Criteria for Diagnostic Performance: The acceptance criteria listed are mostly related to engineering and safety standards (e.g., ISO 14971, IEC 60601-1) and physical characteristics of the device (e.g., laser spot size, transmission, communication with laser systems). There are no criteria provided for diagnostic accuracy, sensitivity, specificity, or similar metrics typically found when evaluating the performance of an AI-powered diagnostic device.
• No Reported Device Performance for Clinical Outcomes: The performance reported is that the device "performs in accordance with its requirements and specifications, in similarity to its predicate device" and "perform as well as its predicate, to be as safe and effective for its intended use as its predicate." This refers to its functionality as a laser delivery system, not its ability to interpret or diagnose.
• No Clinical Study Details: The document mentions "Performance testing was conducted," but this refers to engineering, electrical safety, electromagnetic compatibility, light hazard protection, and verification/validation testing of the device's optical and laser delivery components. It does not describe a clinical study involving patients, experts establishing ground truth, or an AI algorithm.
• Device Type: This device is a "Smart Laser Indirect Ophthalmoscope" used for viewing and delivering laser energy for photocoagulation procedures. It is a tool for a physician to perform a procedure, not a diagnostic AI system that interprets images or makes diagnoses.

In summary, the provided document does not contain the information requested in your prompt because the device being described is a surgical instrument (laser delivery device) and not a diagnostic device that would typically involve acceptance criteria, reported performance, sample sizes, and expert adjudication related to diagnostic accuracy or AI performance.

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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.

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