Search Results

The Iridex 810 Laser is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser.

CONDITION: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy), Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)), Retinal Tears, Detachments, and Holes, Lattice Degeneration, Age-Related Macular Degeneration (AMD), Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma), Retinopathy of Prematurity, Sub-Retinal (choroidal) Neovascularization, Central and Branch Retinal Vein Occlusion

TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments, Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; TSRPC; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments

The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 mm for Treatment and 650 nm for Aiming beam), imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch.

Optical fiber Delivery Devices are provided separately.

The provided text is a 510(k) summary for the Iridex 810 Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing related to electrical safety, laser safety, electromagnetic compatibility, usability, and software.

Crucially, this document does not describe a study involving human readers or AI assistance assessing the device's performance in diagnosing or treating conditions. It's about the safety and fundamental performance of a laser device, not an AI diagnostic tool.

Therefore, I cannot provide information on many of the requested points, such as:

• Sample size for the test set and data provenance: Not applicable, as this is a physical device safety and performance evaluation, not a diagnostic accuracy study.
• Number of experts used to establish ground truth & qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
• Stand-alone (algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to engineering and safety standards, not clinical diagnostic accuracy.
• Sample size for the training set: Not applicable, as this is not an AI/machine learning device being trained.
• How the ground truth for the training set was established: Not applicable.

However, I can extract information related to the acceptance criteria and the summary of non-clinical performance data for the Iridex 810 Laser System as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Meet internal Iridex performance specifications pre- and post-conditioning testing. | PASS. All 5 units passed pre and post ISTA-3A testing (Westpak testing) and Pre-and Post-conditioning Testing (Iridex testing). |

2. Sample Size Used for the Test Set and Data Provenance:

• For "Shipping and Packaging Testing," the sample size was 5 units.
• For other non-clinical tests (Electrical Safety, Laser Safety, EMI/EMC, Usability, Software), the specific sample size is not explicitly stated within this summary. However, these are typically engineering verification tests performed on a limited number of test units to confirm compliance with international standards.
• Data Provenance: The document does not specify the country of origin for the test data but indicates that the testing was performed internally by Iridex ("Iridex testing") and by a third-party lab ("Westpak testing" for packaging). These are non-clinical engineering tests, not patient studies, so "retrospective or prospective" doesn't directly apply in the clinical sense.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the non-clinical performance testing conducted by the manufacturer, Iridex Corporation, and sometimes by accredited third-party testing laboratories. The summary states:

• "The following table summarizes nonclinical testing relevant to the Iridex 810 Laser System (Console and Compatible Delivery Devices) in accordance with the requirements of the design control regulations and established quality assurance procedures."
• "Other than the packaging testing, which is updated to current ISTA 3A guidelines, Verification and Validation method(s) and results are unchanged from those data submitted in K202760; and those data continue to apply to the SUBJECT device."
• "Clinical testing was not required for this product change."

This indicates that the "study" demonstrating performance is a series of engineering verification and validation tests against established international standards for medical devices and lasers.

In summary, this document is for a laser device intended for ophthalmic treatments (e.g., retinal photocoagulation). The "acceptance criteria" and "study" described pertain to the device's fundamental safety, electrical performance, laser output characteristics, usability, and software quality, as per relevant international standards, rather than clinical diagnostic accuracy or AI performance improvements.

Ask a specific question about this device

The Iridex 810 Laser is indicated for retinal photocoagulation, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser.

CONDITION: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy), Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)), Retinal Tears, Detachments, and Holes, Lattice Degeneration, Age-Related Macular Degeneration (AMD), Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma), Retinopathy of Prematurity, Sub-Retinal (choroidal) Neovascularization, Central and Branch Retinal Vein Occlusion.

TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments, Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; TSRPC; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments.

The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 nm for Treatment and 650 nm for Aiming beam), imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch.

Optical fiber Delivery Devices are provided separately.

The provided text describes the Iridex 810 Laser, focusing on its substantial equivalence to a predicate device (OcuLight SL/SLx, Model # 13030 (K020374)). The information provided is for regulatory clearance (510(k)) and primarily addresses engineering and safety verification rather than clinical performance studies typically associated with AI/software devices. Therefore, many of the requested categories related to clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, ground truth establishment for training set) are not applicable or not explicitly detailed in this document.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The studies described are engineering verification tests, not clinical performance studies with patient data. Therefore, the concept of a "test set" from patient data, country of origin, or retrospective/prospective nature is not applicable here. The "test set" effectively refers to the device and its components undergoing prescribed electrical, mechanical, and safety tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of this device's verification, is established via engineering standards and specifications (e.g., IEC standards for electrical and laser safety, software lifecycle processes) and internal product release specifications. The "experts" would be the engineers and technicians performing and verifying these tests against the defined standards.

4. Adjudication Method for the Test Set
Not applicable, as this is not a clinical study involving human assessment of data.

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
No MRMC study was conducted. This device is an ophthalmic laser system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system and does not involve AI algorithms for standalone performance measurement.

7. The Type of Ground Truth Used
The ground truth used for these verification studies are established engineering and medical device safety standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304) and the manufacturer's internal product release specifications.

8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning algorithms that require a training set.

9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.

Ask a specific question about this device