Search Results

The Systane iLux2 is indicated for the application of localized heat and pressure therapy in adult patients with Melbonian Gland Dysfunction (MGD), which is associated with evaporative dry eye, and to capture/store digital images and video of the meibomian glands.

The Subject Device is indicated for the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with evaporative dry eye. The device can capture images and videos of the eyelid margin and meibomian glands. These images can be use in meibography (i.e., visual morphology of meibomian glands).

In treatment mode, light-based heat is used to warm the eyelid tissue to a target range of 38-44 ℃ to melt the meibum blocking the gland orifices. The Eye Care Professionals (ECP) can apply compression to the eyelid to express the meibum through the orifices. At all times, the amount of the heat and pressure applied is under direct control of the ECP who monitors the response of the glands and the comfort of the patient. The inner eyelid temperature is displayed during the treatment process. The source of heating is lime-green and IR optical radiation produced by LEDs incorporated in the Instrument. Images and video can be captured during treatment.

In meibography mode, infrared (IR) light is used in the visualization of meibomian gland morphology. Images can be captured with IR or white light. Video is captured only with white light.

The Subject Device consists of the following:

• Reusable, Hand-Held Instrument Incorporates hardware, software, and . mechanics to facilitate treatment and imaging.
  The Instrument incorporates an LCD touchscreen user interface that is used to view the eyelid margin as well as provides instructions to the ECP during use. Selections can be made through the user interface and images/video can be viewed.

The Instrument is powered by a rechargeable lithium ion battery.

• Docking Station Is used to charge the Instrument's internal battery and transfer . images/video to an external monitor or PC.
• . AC Power Supply - Transfer electricity for the AC electrical outlet to the Docking Station.
• . Photography Tip (Photo Tip) - Is reusable, up to a specified number of attachments, and when coupled with the Instrument it is used to capture images and video. There is electronics in the Photo Tip that interfaces with the Instrument. The Photo Tip is positioned on the cheek bone or eyebrow. The patient contacting material is biocompatible.
• . Smart Tip Patient Interface (Smart Tip) - Is sterile and single-use that when coupled with the Instrument treatment can be provided. There is electronics in the Smart Tip that interfaces with the Instrument. A feature of the Smart Tip is positioned behind the eyelid during the treatment process. The patient contacting material is biocompatible.
• USB & HMDI Cable Attaches Docking Station to external monitor/PC. .

The provided text does not contain detailed information about specific acceptance criteria or an explicit study proving that the device meets those criteria. However, it does list the types of testing performed to ensure the device's safety and performance, implying that internal acceptance criteria were met for each category.

Here's a breakdown of the requested information based on the provided text, with the understanding that specific numerical acceptance criteria and a detailed study report are not present:

1. A table of acceptance criteria and the reported device performance

The document broadly states that the device "met the safety and performance requirements" for its indications for use. Specific numerical acceptance criteria are not provided in this summary.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test sets, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective nature) for the testing performed. The "Simulated Use (Human Factors Evaluation)" implies human subjects were involved, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

The document does not mention any MRMC comparative effectiveness study or any involvement of AI assistance. The device is described as a medical instrument for direct application of therapy and image capture, not an AI-powered diagnostic tool requiring human reader studies to assess AI's impact on performance.

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

Given that the device is a therapeutic and imaging instrument operated by an Eye Care Professional (ECP), the concept of "standalone (algorithm only)" performance without human-in-the-loop is not directly applicable in the context of diagnostic accuracy, as it seems to be primarily a tool to assist a clinician. The software aspect mentioned under "Summary of Testing Performed" would have undergone standalone testing for its functionality and safety, but not in the context of an "algorithm-only" diagnostic accuracy study.

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

The document does not explicitly state the type of ground truth used for performance evaluations. For a device providing "localized heat and pressure therapy" and "capture/store digital images and video," ground truth would likely be based on:

• Physical measurements: For temperature accuracy (e.g., against calibrated thermometers).
• Clinical observation/assessment: For the effectiveness of heat and pressure therapy on MGD, likely by ECPs.
• Image quality assessment: For the captured images and video, likely against established standards for meibography or expert evaluation of image clarity and diagnostic utility.
• Biocompatibility testing: Standardized laboratory tests.
• Sterility testing: Standardized laboratory tests.

8. The sample size for the training set

The document describes testing for device safety and performance rather than the training of an AI algorithm. Therefore, there is no mention of a "training set" or its sample size.

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

As there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not applicable or provided.

Ask a specific question about this device

The iLux System is indicated for the application of localized heat and pressure therapy in adult patients with chronic diseases of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye.

The iLux System is a medical device intended for use by Licensed Eye Care Professionals (ECP) to apply localized heat and pressure therapy to adult patients' lower and/or upper eyelids. The il.ux System consists of a hand-held Instrument coupled to a single-use sterile Disposable component that is positioned behind the eyelid. The iLux System allows the ECP to view the eyelid margin through a magnifier, then warm the eyelid tissue to a target range of 40 to 42 °C to melt the meibum blocking the gland orifices and then apply compression to the eyelid to express the melted meibum through the orifices. The inner eyelid temperature and the amount of force applied to the eyelid are both displayed on the Instrument allowing the clinician to titrate the ideal amount of heating and compression to optimize unclogging of the blocked glands.

The Disposable is a sterile, single-use component that is attached to the iLux Instrument. It includes all parts intended to contact the patient's eyelid.

The iLux Instrument is a handheld device that allows the ECP to view, heat, and compress the portion of the eyelid that is in contact with the Disposable. The source of heating is lime-green and infrared optical radiation produced by LEDs in the Instrument. The ilux Instrument is powered by a rechargeable lithium ion battery. The software Level of Concern is Moderate.

Ancillary accessories include the charging stand with AC power supply.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate table. Instead, it details that the iLux System was studied for non-inferiority against the predicate device (LipiFlow System) for specific effectiveness and safety endpoints. The "reported device performance" are the findings from this non-inferiority study.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 142 subjects (284 eyes). The subjects were randomized into two treatment groups (iLux vs. LipiFlow) in a 1:1 ratio.
• Data Provenance: The study was a clinical study, implying prospective data collection. The document does not specify the country of origin, but it was submitted to the U.S. FDA, so it's likely a study conducted in the U.S. or under international standards acceptable to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical study endpoints (Meibomian Gland Score, Tear Break-Up Time, Ocular Surface Disease Index, pain/discomfort scores, adverse events, etc.). These metrics are typically assessed by trained clinical personnel (e.g., ophthalmologists, optometrists, or research coordinators) according to standardized protocols.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study endpoints. The assessment of endpoints like MGS, TBUT, OSDI, and adverse events would typically follow pre-defined protocols and may involve single assessors or dual assessments with a consensus process, but this is not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Human-in-the-loop/MRMC study was not performed, nor was it relevant for this device. The iLux System is a therapeutic device that applies heat and pressure, not a diagnostic AI system requiring human interpretation. The study was a direct comparison of the therapeutic effect of the iLux device versus a predicate device, each operated by a licensed eye care professional.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

Not applicable/Not done. The iLux System is a medical device operated by a Licensed Eye Care Professional for treatment. It is not an imaging analysis algorithm or a diagnostic tool that operates independently to provide "standalone" performance. Its "performance" is its therapeutic efficacy when used by a human operator, which was assessed in the clinical study.

7. Type of Ground Truth Used:

The "ground truth" for the clinical study was established through:

• Clinical Endpoints/Measurements: Meibomian Gland Score (MGS), Tear Break-Up Time (TBUT), Ocular Surface Disease Index (OSDI), pain scores, discomfort scores, ocular surface staining, Intraocular Pressure (IOP), and Best Spectacle Corrected Visual Acuity (BSCVA). These are objective and subjective measurements commonly used in ophthalmology to assess the condition of the eyes and patient well-being for MGD.
• Adverse Event Reporting: Direct observation and patient reporting of any device/procedure-related adverse events.

8. Sample Size for the Training Set:

Not applicable/Not mentioned. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. It's a physical medical device. The "training" for the device would involve training the eye care professionals on how to use it.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not mentioned. As there's no data-driven "training set" for an AI algorithm, this question is not relevant to the iLux System.

Ask a specific question about this device