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510(k) Data Aggregation
(30 days)
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
| Verification/Validation Method(s) | Acceptance Criteria | Summary of Results (Reported Device Performance) |
|---|---|---|
| IEC 60601-1 Electrical Safety | Meet applicable clauses of IEC 60601-1 | PASS. Device meets requirements of applicable clauses of IEC 60601-1. |
| IEC 60601-2-22 Laser Safety | Meet all applicable IEC 60601-2-22 test items except for EMC, Biocompatibility | PASS. Device meets requirements of applicable clauses of IEC 60601-2-22. |
| IEC 60825-1 Laser Safety | Meet applicable IEC 60825-1 requirements | PASS. Device meets IEC 60825-1 Requirements. |
| IEC 60601-1-2 EMI/EMC | Meet IEC 60601-1-2 Requirements | PASS. The unit met the requirements of applicable clauses of IEC 60601-1-2. |
| IEC 60601-1-6:2010, AMD1:2013 (Usability) | Meet the requirements of the applicable clauses IEC 60601-1-6 | PASS. Device meets requirements of applicable clauses of IEC 60601-1-6. |
| IEC 62304, Medical device software, Software life-cycle processes | Software lifecycle processes and activities meet requirements of applicable clauses of IEC 62304 | PASS. Software lifecycle processes and activities meet IEC 62304 Requirements. |
| Shipping and Packaging Testing: ISTA 1A Procedure: Vibration (10-500 Hz, 30 min/axis, three axes) & Shock Drop (24" Drop on Corner, Edges (1-3) and Face (1-6)). Performance measured by: power measurement (at 50% Duty Cycle), current measurement, visual inspection, product functional inspection (all per product release test procedures; pre- and post-testing). | ISTA 1A Procedure is Performed. Measurement of console power (at 50% Duty Cycle) conforms to product release specifications in pre- and post-ISTA 1A Procedure testing. Measurement of console current in system conforms to product release specifications in pre- and post-ISTA 1A Procedure testing and demonstrates no significant change post-1A Procedure testing. Product and packaging appearance conform to product release specifications in pre- and post-ISTA 1A Procedure testing and are not observed to be adversely affected by ISTA 1A Procedure testing. Product functions, including console and footswitch interaction, conform to product release specifications in pre- and post-ISTA 1A Procedure testing and are not observed to be adversely affected by ISTA 1A Procedure testing. | PASS. Observed Console Power Measurements, Console Current Measurement, Product and Packaging Appearance and Product Function performed pre- and post- ISTA 1A Procedure Testing passed product release specifications and were not adversely affected by ISTA 1A Procedure testing. |
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.
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