Search Results

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

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.

Ask a specific question about this device

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):

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.

Ask a specific question about this device