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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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Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications. A complete list is contained in the Indications for Use Statement.
Ophthalmology: Retinal Photocoagulation, Trabeculoplasty, Iridotomy, Diabetic retinopathy, Peripheral Iridectomy, Posterior and Anterior procedures, Senile macular degeneration.
Ear, Nose and Throat (ENT): Stapedectomy, Stapedotomy, Myringotomies, Lysis of Adhesions, Control of Bleeding, Removal of Acoustic Neuromas, Soft Tissue Adhesion in Micro/Macro Otologic Procedures.
Dermatology: Pigmented lesions, including soar lentgine, Vascular lesions, including cherry hemangiomas and angiokeratomas, Extremeties telangiectasias, including facial and leg telangiectasias, Cutaneous lesions, Flat warts, Dermatosis Papulosa Nigra.
Dentistry: Frenectomy, Treatment of Oral Mucous Cyst, Treatment of Benign Vascular Lesions: Capillary hemangioma, Hemorrhagic hereditary telangiectasia, Capillary/cavernous hemangiomas, Lymphangioma, AV malformation of the tongue, Hemangiolymphangiomas, Photocoagulation of superficial vessels, Vaporization of superficial blood or lymph containing vessels, Treatment of superficial tongue lesions, Tissue management and hemostasis for crown and bridge impressions, Incision and drainage for abscess, Gingivoplasty/ gingivectomy, Operative procedures, Crown and bridge, gingival reduction, Crown lengthening, Hyperplasia (Drug, Irritation, Epulus, ... ), Hemostasis during dental procedures, Operculectomy (Operculotomy), Excisional biopsy, Free Ginvical Graft (Adjunct): Hemostasis of donor site, Hemostasis of graft site, Vestibuloplasty, Soften Gutta Percha, Treatment of canker sores, herpetic lesions, and aphthous ulcers, Laser-assisted bleaching/whitening.

The Novus Spectra solid state, frequency-doubled, green Nd:YAG surgical laser system is an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. Compatible delivery devices include: slit lamps, slit lamp adapters/attachments, laser indirect ophthalmoscopes (LIO), microfilters, collimated handpieces with spot sizes ranging from 200-1200microns, fibers and endocular and endooto probes.

This document is a 510(k) summary statement for the Lumenis Novus Spectra Laser System, seeking substantial equivalence to predicate devices (Elite and Corium laser systems). It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from the provided text.

Here is a summary of what can be extracted or inferred based on the nature of a 510(k) submission:

1. A table of Acceptance Criteria and the Reported Device Performance:

• This information is not provided in the document. 510(k) submissions for substantial equivalence generally focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance targets in the same way a de novo or PMA submission might. The document states the Novus Spectra Laser System "has the same indications for use as the Elite family of lasers and the Corium series of lasers. They have similar functional elements such as treatment wavelengths, pulse rates, treatment power, spot size and cooling system."

Further requested information which is not available in the provided text:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Key takeaway: This document represents a regulatory submission for substantial equivalence based on similarity to existing devices, not a study demonstrating a novel device's performance against predefined acceptance criteria for a specific clinical task. The focus is on showing the new device has "similar functional elements" and "same indications for use" as its predicates.

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