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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 OcuLight GL is currently cleared for retinal photocoagulation and laser trabeculoplasty using ophthalmic delivery devices (IRIS Slit Lamp Adapter, IRIS Laser Indirect Ophthalmoscope, IRIS EndoProbe). The Dermatology Handpiece will expand the intended use of this device for the treatment of vascular and pigmented skin lesions.

The OcuLight GL is a semiconductor-based dermatology laser system which delivers true continuous wave green laser light. For the additional indication in the treatment of vascular and pigmented lesions it will be used in conjunction with fiber optically coupled Dermatology Handpieces which have received prior FDA-premarket clearance (K964074).

The OcuLight GL is a semiconductor-based laser console which delivers green laser light. The OcuLight GL uses infrared (808 nm) semiconductor diode laser light as the primary source of optical energy which is then wavelength converted to a visible green (532 nm) laser light for the treatment delivery.

A second visible red (630-650 nm) semiconductor CW laser is used for aiming. The 532 nm treatment and 630-650 nm pilot/aiming beams are optically combined inside the laser head and therefore follow the same path. The treatment and aiming beams are coaxial (i.e. follow the same path) in the OcuLight GL. The aiming beam is turned on when the OcuLight is placed into Treat mode.

The delivery devices currently cleared for use with the OcuLight GL are the IRIS Slit Lamp Adapter (SLA), the IRIS EndoProbe, and the IRIS Laser Indirect Ophthalmoscope (LIO). Delivery devices not specifically intended for use with the OcuLight GL will not be recognized by the fiber interlock circuit as a valid delivery device.

For the new indications, the OcuLight GL will utilize the Dermatology Handpieces connected to the fiber port. As was true with the three previously FDA-cleared fiber optically coupled delivery devices used with the OcuLight GL, the distal end of the Dermatology Handpieces will be the laser aperture and not the fiber port on the laser console. The laser port is electronically interlocked so that no laser energy can be emitted without the correct connection of a recognized delivery device.

This 510(k) summary (K982031) describes the IRIS Medical Instruments, Inc. OcuLight GL With Dermatology Handpieces. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for its intended use in treating vascular and pigmented skin lesions.

The document primarily covers:

• Submitter and Device Information: Name, address, contact, date prepared, FDA registration, device name, and classification.
• Predicate Devices: A list of legally marketed laser systems to which the OcuLight GL is considered substantially equivalent.
• Intended Use: Expansion of the existing OcuLight GL's use to include vascular and pigmented skin lesion treatment with Dermatology Handpieces.
• Device Description: Explanation of the OcuLight GL's technology (semiconductor-based, green laser light, aiming beam) and how it works with the Dermatology Handpieces.
• Technological Characteristics and Substantial Equivalence: A comparison of the OcuLight GL's characteristics (wavelength, power, delivery devices, indications) to the predicate devices to support the claim of substantial equivalence.
• FDA Response Letter: Confirmation of substantial equivalence and market clearance.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text. The document is strictly a 510(k) submission summary for demonstrating substantial equivalence, not a report on performance studies against acceptance criteria.

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The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.

The OcuLight GL is a semiconductor-based ophthalmic laser photocoagulator which delivers true continuous wave green laser light. It will only be used in conjunction with three fiber optically coupled delivery devices which have received prior FDA-premarket clearance: the IRIS Slit Lamp Adapter (K912918 for retinal photocoagulation and K913430 for laser trabeculoplasty), the IRIS EndoProbe (K894841), and the IRIS Laser Indirect Ophthalmoscope (K903288).

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a modern AI/ML device submission would. The document is a 510(k) summary for a medical device (OcuLight GL laser photocoagulator) from 1996, which predates advanced AI/ML algorithms and their associated rigorous validation frameworks.

The document focuses on demonstrating substantial equivalence to existing predicate devices, a common pathway for medical device clearance. This process typically involves showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as legally marketed devices, rather than meeting specific performance thresholds against a defined ground truth.

Therefore, many of the requested data points (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth for training/test sets, training set sample size) are not applicable or mentioned in this type of 510(k) summary for a hardware-based laser device from that era.

Below is an attempt to structure the available information per your request, with significant caveats where information is missing or not relevant to the context of this device type and submission era.

Acceptance Criteria and Device Performance

Note: The acceptance criteria here are inferred from the 510(k) summary's focus on substantial equivalence. There are no explicit performance metrics (e.g., sensitivity, specificity, accuracy) defined or evaluated against a ground truth as would be expected for an AI/ML device.

Detailed Information (as far as available from the text):

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

   • Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm. The demonstration of substantial equivalence relies on comparing technical specifications and intended use with predicate devices, rather than a clinical trial with a defined patient cohort.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. No "test set" or ground truth establishment by experts for performance evaluation is described.

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

   • Not applicable/Not provided.

4. 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:

   • No. This is a hardware device for surgical procedures (laser photocoagulation), not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance is not relevant or described.

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

   • Not applicable/No. This device is a laser system operated by a human ophthalmologist; there is no "algorithm only" performance to evaluate.

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

   • Not applicable. The concept of "ground truth" for evaluating an AI/ML algorithm's output is not relevant to this type of device submission. The efficacy and safety are deemed equivalent to predicate devices, which would have had their own clinical data or established safe use.

7. The sample size for the training set:

   • Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning.

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

   • Not applicable/Not provided.

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