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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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The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including:

• . Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
  • Proliferative and nonproliferative diabetic retinopathy .
  • Choroidal neovascularization .
  • Branch retinal vein occlusion .
  • . Retinal tears and detachments
  • Retinopathy of prematurity .
• Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma

The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.

The provided document is a 510(k) summary for the Lumenis Vision One Laser System, an ophthalmic surgical laser. It establishes substantial equivalence to a predicate device and details the device's intended use and technical specifications. However, it does not contain the specific information required to answer your request regarding acceptance criteria for a study proving device performance.

Specifically, the document states under "VII. Performance Data:" that "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted." However, it does not provide the detailed results of these tests, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Cannot be answered from the provided text. The document states that performance testing was conducted but does not provide specific acceptance criteria or detailed reported performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be answered from the provided text. The document does not describe a clinical study or a test set, nor does it provide details on sample size or data provenance for any performance testing.

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):

• Cannot be answered from the provided text. There is no mention of a test set, ground truth establishment, or experts involved in performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be answered from the provided text. There is no information about a test set or adjudication methods.

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:

• Cannot be answered from the provided text. This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Cannot be answered from the provided text. This device is a surgical laser, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot be answered from the provided text. There is no information on ground truth establishment for any performance testing.

8. The sample size for the training set:

• Cannot be answered from the provided text. This device is a surgical laser; the concept of a "training set" in the context of machine learning or AI is not applicable here.

9. How the ground truth for the training set was established:

• Cannot be answered from the provided text. Not applicable for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, patient population, principles of operation, and method of energy delivery. It does not provide the detailed performance study information with acceptance criteria, sample sizes, or ground truth establishment that you are requesting.

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