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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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