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The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye. Examples include: photocoagulation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation, endophotocoagulation, treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.

The Iridis Ophthalmic Photocoagulator consists of a main console with controls and a foot switch. The laser emits a coherent beam of light at 810 nm. Delivery systems attached to the laser then transmit the beam to treatment sites within the eye. The delivery systems are independent devices, manufactured by independent manufacturers, which attach to the Iridis Ophthalmic Photocoagulator either by direct connection at the laser aperture or through attachments, such as the slit lamp adapter.

This document, a 510(k) summary for the Iridis Ophthalmic Photocoagulator, does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or meet specific performance criteria through a dedicated study.

Here's a breakdown of why the requested information cannot be found in the provided text:

• Acceptance Criteria and Reported Device Performance: This document states "Performance Data: None required." (Section 1). This explicitly indicates that specific performance data, including acceptance criteria and how the device met them, was not part of this submission.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set): Since "Performance Data: None required" was stated, there is no mention of any study that would typically involve these elements. The submission relies on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than a clinical or performance study.

In summary, none of the requested information regarding acceptance criteria or a study proving the device meets them is present in the provided text. The 510(k) clearance for this device was based on demonstrating substantial equivalence to already legally marketed predicate devices, negating the need for new performance studies in this specific submission.

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