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In the YAG mode (Tango, Ultra Q, Ultra Q Reflex, Tango Reflex): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.

In the SLT mode (Tango, Solo, Tango Reflex): -Selective Laser Trabeculoplasty (SLT)

These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.

The provided text is a 510(k) summary for the Ellex YAG/SLT Laser. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. It does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, or accuracy) or a multi-reader, multi-case comparative effectiveness study involving human readers and AI assistance.

The document states: "Since the Ellex YAG/SLT devices use the same technology and principles as the predicate device, clinical data is not required." This means that traditional clinical performance studies (like those that would establish detailed acceptance criteria for diagnostic accuracy or reader improvement) were not conducted or submitted for this 510(k) clearance. The focus of this submission is on demonstrating fundamental safety and technological equivalence to a previously cleared device.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study design, as this information is not present in the provided document.

The document primarily covers non-clinical tests (electrical safety, EMC, laser safety, biocompatibility, and software verification/validation) to support the safety and substantial equivalence of the new device to the predicate device.

Key takeaway from the document: The applicant relied on substantial equivalence to a predicate device (Lumenis Selecta Duet, K021550) and extensive non-clinical testing to demonstrate the safety and effectiveness of the Ellex YAG/SLT Laser, rather than conducting new clinical performance studies with specific acceptance criteria that would assess diagnostic or treatment effectiveness in a quantitative manner.

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