(93 days)
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.
| Acceptance Criterion Category | Reported Device Performance |
|---|---|
| Biocompatibility | The Subject Device met the safety and performance requirements. |
| Sterility and EO Residual | The Subject Device met the safety and performance requirements. |
| Packaging Integrity | The Subject Device met the safety and performance requirements. |
| Transportation | The Subject Device met the safety and performance requirements. |
| Optical Radiation Safety | The Subject Device met the safety and performance requirements. |
| Electromagnetic Compatibility and Electrical Safety | The Subject Device met the safety and performance requirements. |
| Stability/Shelf-Life | The Subject Device met the safety and performance requirements. |
| Performance/Functionality/Safety | The Subject Device met the safety and performance requirements. |
| Software | The Subject Device met the safety and performance requirements. |
| Simulated Use (Human Factors Evaluation) | The Subject Device met the safety and performance requirements. |
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.
§ 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.