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· Selecta Duet LED or Digital Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, and selective laser trabeculoplasty.

· Selecta LED Trio or Digital Trio: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, selective laser trabeculoplasty, and retinal photocoagulation.

The Selecta Duet LED and Digital Duet subject devices are each a fully integrated, highperformance diagnostic slit lamp and therapeutic laser delivery system. The diagnostic slit lamp is for examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. The integrated Nd:YAG Q-Switch laser module provides short pulses at the wavelength corresponding with the selected operating mode. Two modes are available: PD (YAG) mode: 1064 nm for photodisruption (PD) of ocular tissues in procedures such as posterior capsulotomy, iridotomy, and iridectomy, and SLT mode: 532 nm for Selective Laser Trabeculoplasty (SLT). The Selecta LED Trio and Digital Trio subject devices are each created by connecting the Selecta LED Duet and Digital Duet, respectively, to a compatible, FDA-cleared, Lumenis continuous 532 nm wavelength photocoagulator laser, via the LaserLink S. When the user connects the Duet to the LaserLink S, the Duet-part acts only as a Slit Lamp since the integrated Duet-laser is disabled and the laser in the external photocoagulator takes over. This combination adds the ability to perform retinal photocoagulation, as well as other indications cleared for the continuous 532 nm wavelength photocoagulator laser. The user disconnects the Duet from the LaserLink S for the system to perform as a Duet.

The provided text is an FDA 510(k) summary for the Lumenis Selecta Duet LED, Digital Duet, Selecta LED Trio, and Digital Trio Laser Systems. It describes the device, its intended use, and a comparison to a predicate device, concluding with performance testing.

However, the document does not contain the kind of detailed information about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information that would be typically found in a clinical study report for an AI/ML-based medical device.

The "Performance Testing" section primarily refers to compliance with standards for medical electrical equipment and laser safety, and software verification. It states:

• "Evaluating the implemented changes using the same recognized standards that were used for the cleared devices" (listed standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 15004-2, ISO 14971).
• "Software/Bench Testing" stating that "Lumenis developed and verified the software in accordance with a major level of concern described in the FDA 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and also per the IEC 62304:2006 and A1:2015 Medical Device Software - Software Life Cycle Processes standard." and "The software/bench tests conducted on the modifications confirmed that they met their requirements."

This document describes a device that is essentially a hardware update and software refresh of a previously cleared laser system, not a novel AI/ML diagnostic or assistive algorithm for which the requested detailed study information would be relevant. The changes are described as "primarily to be responsive to user feedback, upgrade to the latest user interface, or reflect a need to change a supplier or manufacturing contractor."

Therefore, I cannot extract the requested information from this document because it does not appear to describe a study proving an AI/ML device meets acceptance criteria through clinical performance metrics. The phrase "device meets the acceptance criteria" in this context refers to meeting engineering/safety/performance standards for a laser system, not the kind of AI/ML performance metrics typically seen for diagnostic algorithms.

In summary, based on the provided text, the requested information (performance study details for an AI/ML device) is not available. The document focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized technical standards and software verification, rather than clinical performance trials of a new diagnostic AI/ML algorithm.

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The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).

The Smart LIO is indicated for use in the following photocoagulation procedures:

• Panretinal photocoagulation;
• Segmental peripheral photocoagulation;
• Retinopexy; and,
• Pediatric retinal repairs (under general anesthesia).

The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:

• Lumenis Novus Spectra Laser System;
• Lumenis Vision One Laser System; and
• Lumenis Smart532TM Laser System.

The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is used in conjunction with a compatible Lumenis ophthalmic laser systems. The LIO illuminates and magnifies the fundus image for observation, and when connected to a Lumenis ophthalmic laser system, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.

The Smart LIO is a wireless headset worn on the physician's head and is used to treat patients in a supine position or who could not otherwise be treated using a standard slit lamp delivery system.

The provided text describes the regulatory filing for a medical device (Smart Laser Indirect Ophthalmoscope) and includes a summary of its performance testing for substantial equivalence. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria, reported performance, sample sizes, expert qualifications, or ground truth establishment in the context of diagnostic accuracy or effectiveness.

The document focuses on demonstrating that the Smart LIO performs similarly to its predicate device and meets safety and performance standards for a laser delivery device. It does not describe a study to assess diagnostic performance with human readers or AI.

Therefore, I cannot populate the requested table and provide answers to questions 2 through 9 based on the provided text.

Here is why:

• No Acceptance Criteria for Diagnostic Performance: The acceptance criteria listed are mostly related to engineering and safety standards (e.g., ISO 14971, IEC 60601-1) and physical characteristics of the device (e.g., laser spot size, transmission, communication with laser systems). There are no criteria provided for diagnostic accuracy, sensitivity, specificity, or similar metrics typically found when evaluating the performance of an AI-powered diagnostic device.
• No Reported Device Performance for Clinical Outcomes: The performance reported is that the device "performs in accordance with its requirements and specifications, in similarity to its predicate device" and "perform as well as its predicate, to be as safe and effective for its intended use as its predicate." This refers to its functionality as a laser delivery system, not its ability to interpret or diagnose.
• No Clinical Study Details: The document mentions "Performance testing was conducted," but this refers to engineering, electrical safety, electromagnetic compatibility, light hazard protection, and verification/validation testing of the device's optical and laser delivery components. It does not describe a clinical study involving patients, experts establishing ground truth, or an AI algorithm.
• Device Type: This device is a "Smart Laser Indirect Ophthalmoscope" used for viewing and delivering laser energy for photocoagulation procedures. It is a tool for a physician to perform a procedure, not a diagnostic AI system that interprets images or makes diagnoses.

In summary, the provided document does not contain the information requested in your prompt because the device being described is a surgical instrument (laser delivery device) and not a diagnostic device that would typically involve acceptance criteria, reported performance, sample sizes, and expert adjudication related to diagnostic accuracy or AI performance.

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