(211 days)
The TearCare MGX System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.
The TearCare MGX System is designed to deliver controlled, precise heat to the tarsal plates and underlying meibomian glands of the eyelids for 15 minutes, followed by an optional warming hold time of up to 10 minutes to allow for manual expression. The TearCare MGX System is comprised of a reusable SmartHub, SmartCable, Charging Nest and charging adapter, and single use SmartLids.
The TearCare MGX System is operated by an eye care practitioner, who affixes the SmartLids to the patient's eyelids, connects the SmartLids to the SmartHub with the SmartCable, and initiates the therapy session on the SmartHub. In the same manner as the predicate device, the system increases the temperature from the lowest warmth setting (41°C) to the highest warmth setting (45°C) when the therapy starts. The SmartHub controls the temperature until the 15-minutes of therapy are complete, at which time the system visually and audibly signals the end of therapy. At the end of the 15-minute core therapy, the TearCare MGX System transitions to an optional Warming Hold Time (WHT) that may last up to a maximum of 10 minutes. WHT holds the temperature at the lowest warmth setting (Warmth setting 1 and temperature set point of 41°C) allowing the eye care practitioner to individually express each eyelid while the lids are warm. To complete the TearCare MGX procedure, the eye care practitioner removes the SmartLid devices one at a time from the patient, then uses the separately available meibomian gland expression forceps (Clearance Assistant) to manually express the meibomian glands immediately following the eyelid heat therapy. Heat is discontinued once the SmartLid is removed prior to expression, at the end of the optional 10-minute WHT, or at any time the eye care practitioner utilizes the SmartHub control to interrupt (pause or stop) treatment.
The subject TearCare MGX System is technologically the same as the predicate TearCare MGX System cleared under 510(k) K231084. Notably, there are no changes to the system impacting thermal exposure and limits regarding temperature control and regulation. The subject device of this submission proposes changes to the TearCare MGX System that impact the Instructions for Use (IFU), rather than a device technological change. The procedural instructions for use are updated with additional instruction for the application of the SmartLids including an earpiece fitment check to assess whether the ear loop requires further support.
The provided FDA clearance letter for the TearCare MGX System (K242786) focuses on demonstrating substantial equivalence to a predicate device (K231084). The core of this submission is a change to the Instructions for Use (IFU) to improve the fitment of the SmartLids, rather than a change to the device's technological characteristics or its core therapeutic performance.
Therefore, the primary "study" described in this document is a clinical validation study of the updated IFU for SmartLids fitment, not a study exploring the therapeutic effectiveness of the device itself or its standalone performance in a medical diagnosis context. The acceptance criteria and device performance listed below directly relate to this fitment validation.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Earloop components remain affixed to the ears for the duration of the simulated treatment (25 minutes). | All earloop components remained affixed to the ears in all subjects for the duration of the 25-minute simulated treatment. The study validated the updated instructions for use, which include steps to "check for earpiece fitment" and a recommendation to use surgical tape if a "loose" fitment is identified. |
| SmartLid devices remain securely affixed to the eyelid throughout the simulated treatment. | The study demonstrates that the TearCare MGX device components (including SmartLids) remain securely affixed to the eyelid throughout a simulated 25-minute treatment when applied according to the updated instructions for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 21 subjects
- Data Provenance: The document does not explicitly state the country of origin, but it is a clinical validation study performed to address a specific usability/fitment aspect of the device. The study is prospective, as it was conducted to validate new instructions for use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The study described is a clinical validation of device fitment, not a diagnostic accuracy study requiring expert adjudication of medical images or conditions. The "ground truth" was whether the device remained affixed. This was directly observed during the study.
- Number of Experts: Not applicable in the context of diagnostic "ground truth" establishment. The assessment of whether earloop components remained affixed would have been performed by the study staff (e.g., eye care practitioners or study coordinators) as part of the observation.
- Qualifications of Experts: Not specified or applicable for a fitment validation. The study involved eye care practitioners applying the device, but their role was in applying the device and observing its fit, not in establishing a medical "ground truth."
4. Adjudication Method for the Test Set
Not applicable. This was a direct observation study of device fitment and retention, not a study requiring adjudication of expert interpretations for a ground truth. The success criterion was whether the device remained affixed, which is a binary, observable outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided document describes a clinical validation study focused on the fitment and retention of the TearCare MGX System's earloop components and SmartLids, specifically for the purpose of validating updated Instructions for Use. It is not a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the therapeutic effectiveness of the device or human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. The TearCare MGX System is an Eyelid Thermal Pulsation System, a physical device intended for localized heat therapy. It is not an AI algorithm or a diagnostic software that would have "standalone" performance in the sense of processing data without human involvement for diagnosis. The closest equivalent to "standalone" performance for such a device would be its ability to maintain therapeutic temperature or its physical function, which is assessed through bench testing (e.g., thermal safety, electrical safety, EMC). The clinical validation study described is about the usability and fitment of its components when applied by a human practitioner.
7. The Type of Ground Truth Used
The ground truth for the clinical validation study was direct observation of device fitment and retention. Specifically, whether the earloop components and SmartLids remained securely affixed to the ears and eyelids, respectively, for the duration of the simulated treatment.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a physical medical device (Eyelid Thermal Pulsation System) and a clinical validation of updated instructions for its use. There is no "training set" in the context of machine learning or AI algorithms for this device. The development of the device itself would involve engineering design, testing, and simulated use, but not typically a "training set" like in software development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of AI or machine learning for this device.
§ 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.