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The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below:
Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy): Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments
Glaucoma (Primary Open Angle, Closed Angle): Laser Trabeculoplasty; Iridotomy, Iridoplasty
Retinal Tears and Detachments: RPC; Focal and Grid Laser Treatments
Lattice Degeneration: RPC; Focal and Grid Laser Treatments
Age-related Macular Degeneration (AMD): RPC; Focal and Grid Laser Treatments
Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma): RPC; Focal and Grid Laser Treatments
Retinopathy of Prematurity: RPC; Focal and Grid Laser Treatments
Sub-Retinal (choroidal) Neovascularization: RPC; Focal and Grid Laser Treatments
Central and Branch Retinal Vein Occlusion: RPC; Focal and Grid Laser Treatments
Dermatology (Pigmented Skin Lesions, Vascular lesions): Focal Laser Treatments
Ear, Nose and Throat (Otosclerotic hearing loss and/or diseases of the inner ear): Stapedectomy, Stapedotomy, Myringotomies, Lysis of Adhesions, Control of Bleeding, Removal of Acoustic Neuromas, Soft tissue Adhesion in Micro/Macro Otologic Procedures

The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

This looks like a 510(k) summary for a medical device seeking clearance, rather than a study proving a device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and comparable performance without necessarily conducting extensive de novo clinical studies with predefined acceptance criteria.

Based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • The document does not provide a table of acceptance criteria or reported device performance in the way one would see for a clinical study with specific performance metrics (e.g., sensitivity, specificity, accuracy).
   • Instead, it states that the device, IRIS Medical OcuLight GL/GLx, is "substantially equivalent" to legally marketed predicate devices, specifically the OcuLight SL/SLx systems and the Lumenis Novus Spectra (K022327).
   • The basis for this substantial equivalence is primarily rooted in the device's intended use, technological characteristics (wavelength, pulse duration, spot size, energy densities), and the expansion of indications for use not requiring changes to hardware or firmware.
     • Key comparative points mentioned:
       • OcuLight GL/GLx: True continuous wave green laser (532 nm).
       • Lumenis Novus Spectra: Delivers the same 532nm wavelength, pulses of equivalent duration, treatment spots of equivalent size, and equivalent energy densities to the OcuLight GL/GLx.
       • OcuLight SL/SLx: Uses 810 nm wavelength diode laser. The comparison here is largely about the existence of similar devices for ophthalmic and other applications, rather than direct numerical performance comparison for the 532nm device against the 810nm device. The expansion of indications for GL/GLx to include ENT applications is justified by the existence of Lumenis Novus Spectra with similar technology for these applications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable. The submission explicitly states "Non-Clinical performance Data: None" and "Clinical performance Data: None." This indicates that no new clinical or non-clinical studies with test sets were conducted for this 510(k) submission to demonstrate performance against specific criteria. The argument for substantial equivalence relies on existing knowledge of the predicate devices and the physical characteristics of the new device.

3. 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):

   • Not applicable. As no test set performance data was provided, there was no need for experts to establish ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No test set was used.

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. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical laser device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. No ground truth data was generated or used in this submission as no new clinical or non-clinical performance studies were conducted.

8. The sample size for the training set:

   • Not applicable. This is a hardware device; machine learning training sets are not relevant here.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a laser surgical instrument. It demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting new clinical study data with predefined acceptance criteria and performance results. Therefore, most of the requested information regarding study design, sample sizes, and ground truth establishment is not present in this type of submission.

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The IRIDEX OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems.

The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

The IRIS Medical® OcuLight® GL/GLx device is a laser system indicated for various medical treatments, primarily in ophthalmology (retinal photocoagulation, laser trabeculoplasty) and also for vascular/pigmented skin lesions and other laser treatments.

1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Size and Data Provenance & 3. Number and Qualifications of Experts & 4. Adjudication Method & 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study & 6. Standalone Performance & 7. Type of Ground Truth & 8. Sample Size for Training Set & 9. How Ground Truth for Training Set was Established

Based on the provided 510(k) summary, the device's acceptance criteria and performance are established through substantial equivalence to predicate devices, rather than through specific performance metrics from a clinical study on the OcuLight GL/GLx itself.

The document explicitly states:

• "Non-Clinical performance Data: None"
• "Clinical performance Data: None"

Therefore, the following information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided for the OcuLight GL/GLx within this document. The "acceptance criteria" presented here are implicitly the FDA's determination of substantial equivalence based on the device's technological characteristics and intended use being similar to legally marketed predicate devices.
• Sample Size Used for the Test Set and Data Provenance: No test set or associated data is described.
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as no ground truth establishment for a test set is described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or referenced.
• Standalone Performance: No standalone performance data (algorithm-only) is presented as this is a physical laser device, not an AI or algorithmic diagnostic tool.
• Type of Ground Truth Used: Not applicable, as no external ground truth was established for the device's performance in this filing.
• Sample Size for the Training Set: Not applicable as this is not an AI/ML device that requires a training set in the conventional sense.
• How the Ground Truth for the Training Set was Established: Not applicable.

Study Proving Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" that proves the OcuLight GL/GLx meets the acceptance criteria of the FDA is the application for 510(k) Pre-market Notification, demonstrating Substantial Equivalence (SE) to legally marketed predicate devices.

Predicate Devices asserted by IRIDEX Corporation:

• IRIDEX Corporation's IRIS Medical OcuLight GL Laser (K960971 and K982031)
• IRIDEX Corporation's IRIS Medical OcuLight SL/SLx Laser (K020374)
• Lumenis Novus Spectra (K022327)
• Alcon Ophthalas® 532 Laser (K962592)

Reasoning for Substantial Equivalence (as described in the document):

1. Intended Use: The OcuLight GL/GLx shares the same intended uses as the predicate devices, including retinal photocoagulation, laser trabeculoplasty, treatment of vascular and pigmented skin lesions, and other laser treatments. The document lists numerous specific conditions and treatments, implicitly asserting that these are within the scope of the predicate devices.
2. Technological Characteristics:
   • The OcuLight GL/GLx is described as a "semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments."
   • The document explicitly states that "The expansion of the indications for use for the proposed OcuLight does not result in a change to the hardware or firmware for the currently marketed OcuLight GL/GLx." This implies the underlying technology is consistent with previous versions.
   • Comparisons to specific predicates highlight shared characteristics:
     • Lumenis Novus Spectra: "delivers the same infrared wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx." (Note: there seems to be a minor inconsistency here, as OcuLight GL/GLx is described as 532 nm green laser by IRIDEX, and Lumenis Novus Spectra delivers "infrared wavelength" in this comparison. This might suggest the comparison is more general, or a slight error in wording in the summary provided for the Lumenis device description).
     • Alcon Ophthalas 532 Laser: "delivers a similar wavelength [532 nm], pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx." Both use a variety of delivery systems like slit lamps, indirect ophthalmoscopes, and endoprobe handpieces.
     • IRIS Medical OcuLight SL/SLx Laser: Indicated for similar ophthalmic treatments, but uses an 810 nm diode laser. This comparison points to the similarity in intended use for ophthalmic applications, even with a different wavelength for some predicate devices cited.

In conclusion, the 'study' demonstrating the device meets "acceptance criteria" (defined as substantial equivalence to legally marketed devices) is the submission of a 510(k) premarket notification. This notification asserts and provides evidence for the device's similarity in intended use and technological characteristics to existing devices, without presenting new clinical or non-clinical performance data for the OcuLight GL/GLx itself. The FDA reviewed this submission and determined the device was substantially equivalent.

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