(254 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 a powered device intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD). The TearCare MGX™ System is comprised of a TearCare SmartLids" device (PN 07064) and a TearCare System Kit (PN 06985), containing the TearCare SmartHub™ (PN 07066), SmartCable (PN 06998), Charging Nest (PN 07067), and IFU (PN 06988). The TearCare MGX™ System warms the eyelid(s) by heating the SmartLids to a maximum set point of 45°C. Heat is applied to the external or cutaneous surface of the eyelids via the adherent, disposable SmartLids that are powered by the SmartHub. The TearCare MGX™ System can warm the eyelids of one or both eyes at a time. A medical grade silicone adhesive on the SmartLid device surface physically and thermally couples the devices to the external (cutaneous) surface of the eyelids. The SmartHub includes a device port for SmartLid device attachment via a SmartCable. Additionally, the SmartHub includes an intuitive touchscreen interface, temperature control processor, and a rechargeable battery. The operator affixes the devices to the patient's eyelids to initiate a treatment session and may adjust the system warmth level during a session. After completion of the core thermal cycle, an extended warming time will automatically begin and stay active for up to 10 minutes at a set target temperature of 41°C that is not permitted to not exceed 43°C. The SmartLid devices are disposable and are not intended to contact the cornea or conjunctival surfaces of the eye. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian glands. The core thermal cycle lasts 15 minutes, followed by an optional extended warming time which may last up to an additional 10 minutes. After TearCare MGX treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare MGX System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare MGX System has not been established without manual meibomian gland expression.
The provided text describes the nonclinical bench testing and a clinical validation study performed for the TearCare MGX System to demonstrate its substantial equivalence to the predicate TearCare System. The device is a thermal pulsation system for treating evaporative dry eye disease due to meibomian gland dysfunction (MGD).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define a column titled "Acceptance Criteria" with pass/fail thresholds for a broad set of performance metrics. Instead, it details that the device "met the minimum and maximum temperature specifications with 95% confidence and 90% reliability" in the clinical study, and that bench testing demonstrated compliance with applicable requirements. The core performance is related to maintaining a specific temperature range on the eyelid and ensuring corneal safety.
Based on the "Clinical Validation Study Summary" section (pages 16-17):
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Outer Eyelid Temperature | Maintain 41°C ± 2°C (lowest setting) | |
| Maintain 45°C ± 2°C (highest setting) | Lowest Setting (41°C): Mean 41.2°C ± 0.31°C (Range 40.1 - 41.8°C) | |
| Highest Setting (45°C): Mean 44.2°C ± 0.46°C (Range 42.9 - 45.1°C) | ||
| Corneal Temperature (Safety) | Maintain safe corneal temperature (No specific numerical acceptance criterion given, but implicitly below damaging levels) | Lowest Setting (41°C): Mean 35.0°C ± 0.70°C (Range 33.4 - 36.7°C) |
| Highest Setting (45°C): Mean 35.6°C ± 0.78°C (Range 34.0 - 36.9°C) | ||
| Minimal/Maximal Temperature Specifications | Met with 95% confidence and 90% reliability | Met |
| Adverse Events | No adverse events | No adverse events reported |
| Slit Lamp Exams | No clinically significant changes | No clinically significant changes observed |
| Earloop Fit and Retention | Earloop components remain securely affixed throughout simulated treatment. | All Earloop components remained affixed to the ears in all subjects for the duration of the 25-minute simulated treatment when secured with surgical tape. |
2. Sample Sizes and Data Provenance
- Test Set (Clinical Validation Study):
- Sample Size: 15 adult subjects (30 eyes)
- Data Provenance: Retrospective or Prospective is not explicitly stated, but the description "clinical validation testing... to demonstrate in acute clinical study" implies a prospective study. Country of origin not specified, but the submission is to the US FDA.
- Additional Clinical Validation Study (for Earloop Fit):
- Sample Size: 21 subjects
- Data Provenance: Similar to the above, likely prospective and in the US.
3. Number of Experts and Qualifications for Ground Truth
The text does not mention the use of experts to establish a "ground truth" in the traditional sense of image interpretation for AI. The clinical study focused on direct physiological measurements (temperature) and clinical observations (slit lamp exams, adverse events) to assess performance and safety. Therefore, this section is not directly applicable to the described studies. The measurements themselves are the "ground truth."
4. Adjudication Method for the Test Set
Not applicable, as the data are direct quantitative measurements (temperatures) and clinical observations (adverse events, slit lamp findings) rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study was a clinical validation of the device's thermal performance and safety, not a study evaluating human reader performance with or without AI assistance. The device itself is not an AI-assisted diagnostic tool, but rather a therapeutic heat delivery system.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical system that applies heat; it does not have a standalone algorithm for diagnostic or interpretative purposes. The software controls the device's function, and its functionality was verified through bench testing, alongside the hardware performance.
7. Type of Ground Truth Used
- For Thermal Performance: Direct temperature measurements using thermocouples (outer eyelid) and an IR camera (cornea).
- For Safety: Clinical observations including slit lamp exams and adverse event reporting.
- For Earloop Fit: Direct observation of earloop retention (whether they remained affixed with tape).
8. Sample Size for the Training Set
The document does not mention an AI/machine learning model that would require a "training set." The studies described are for validation of a medical device, not for the development or testing of an AI algorithm based on patient data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no apparent training set for an AI model mentioned in the document.
§ 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.