(116 days)
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.
| Acceptance Criteria (Non-inferiority) | Reported Device Performance (compared to LipiFlow) |
|---|---|
| Effectiveness Endpoints: | |
| Meibomian Gland Score (MGS) improvements from baseline | Non-inferior: MGS improved significantly from baseline in both groups at week 2 and week 4. Improvements did not differ significantly between the two groups. |
| Tear Break-Up Time (TBUT) improvements from baseline | Non-inferior: TBUT improved significantly from baseline in both groups at week 2 and week 4. Improvements did not differ significantly between the two groups. |
| Ocular Surface Disease Index (OSDI) improvements from baseline | Non-inferior: OSDI improved significantly from baseline in both groups at week 2 and week 4. Improvements did not differ significantly between the two groups. |
| Safety Endpoints: | |
| Device/procedure-related adverse events (AEs) | Comparable (minor differences): Four AEs occurred in iLux arm (burning sensation, petechial hemorrhage, transient decrease in BSCVA with superficial punctate keratitis). All self-limited and resolved without sequelae. |
| Discomfort and pain scores (relative to baseline and predicate) | Comparable (minor differences): Pain and discomfort scores significantly lower from baseline in both groups. Immediately post-treatment, pain/discomfort was significantly lower for LipiFlow, but scores did not differ significantly between groups at day 1, week 2 (pain), or week 4 (pain). At week 4, iLux discomfort score was significantly lower. |
| Ocular surface staining changes from baseline | Comparable: Significantly increased immediately post-treatment in both groups, then significantly reduced relative to baseline at day 1, week 2, and week 4. No significant difference between groups. |
| Intraocular pressure (IOP) changes | Comparable: No clinically significant changes in IOP observed in either group. |
| Best Spectacle Corrected Visual Acuity (BSCVA) changes | Comparable: Significantly reduced immediately post-treatment in both groups (not clinically meaningful). Significantly improved relative to baseline at week 2 and week 4 in both groups, with no significant difference between groups. |
| Non-Clinical Performance Requirements (implicitly met via verification and validation) | Met: Biocompatibility, Sterility and EO Residual, Packaging Integrity, Transportation, Optical Radiation Safety, Electromagnetic Compatibility and Electrical Safety, Stability/Shelf-Life, Performance/Functionality/Safety, Software. Outcomes demonstrated the iLux System met safety and performance requirements for its indication for use. |
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.
§ 886.5200 Eyelid thermal pulsation system.
(a)
Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;
(2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions;
(3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components;
(4) The device should be demonstrated to be biocompatible; and
(5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.