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The TearCare® 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.

To use the TearCare System, the flexible SmartLids are applied to the external surface of the upper and lower eyelids of the right and left eye of the patient. The SmartLids are then connected to the SmartHub. When the SmartHub is turned on and the eye care professional initiates the procedure, the TearCare System begins delivering heat to the eyelids. 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 gland orifices. A complete TearCare session lasts 15 minutes.

After TearCare 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 System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare System has not been established when used without manual meibomian gland expression.

The TearCare System is comprised of the following key components and accessories:

• . SmartHub – a reusable component that incorporates hardware and software to power the SmartLids during treatment. The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the user to manually adjust the temperature up or down to a level that is comfortable for the patient. The SmartHub is powered by an internal lithium-ion battery and has an intuitive 4-function, 3-button interface which provides the user the status and control of treatment initiation, treatment temperature setting, remaining treatment duration, and treatment termination.
• . Charging Nest - a reusable plastic desktop cradle that holds one SmartHub in order to recharge the SmartHub battery.
• Charging Adapter and Wall Plug - a reusable AC/DC wall-mount adapter that accommodates 80-264 VAC input voltage and provides 9.0 VDC output voltage to the SmartHub through the Charging Nest.
• SmartLids – a single use component of the TearCare System that is designed to conform to the upper and lower eyelid. They contain flexible circuits, sensors and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. Each SmartLid is connected to the SmartHub by a cable integrated into the SmartLid. The integrated cable is four feet in length.

The provided text details the acceptance criteria and a clinical validation study for the TearCare® System, however, it does not describe an AI/ML device. Therefore, some of the requested information (like effect size of AI assistance, standalone algorithm performance, number and qualifications of experts for ground truth, and adjudication method) is not applicable or cannot be extracted from the given text.

Here's the available information presented in the requested format:

1. A table of acceptance criteria and the reported device performance

The document focuses on demonstrating substantial equivalence to a predicate device (LipiFlow® Thermal Pulsation System) rather than explicit, quantifiable acceptance criteria with pass/fail thresholds for each performance metric as would be typical for an AI/ML device. However, it does present performance data for various safety and effectiveness endpoints that implicitly serve as criteria for demonstrating equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size for Clinical Validation Study (Thermal Safety): 15 adult subjects (30 eyes).
• Sample Size for Randomized Clinical Trial ("OLYMPIA"): 235 subjects (470 eyes) from 10 investigative centers. This was split into two cohorts due to a SmartLid design change:
  • Cohort 1: 93 subjects (47 LipiFlow / 46 TearCare)
  • Cohort 2: 142 subjects (73 LipiFlow / 69 TearCare)
  • Effectiveness endpoints assessed using data from Cohort 2.
  • Safety endpoints evaluated separately for Cohort 1 and 2.
• Data Provenance:
  • Clinical Validation Study: Not explicitly stated, but likely prospective.
  • Randomized Clinical Trial ("OLYMPIA"): Prospective, multicenter, randomized, non-inferiority, masked, controlled clinical trial conducted in the United States (10 investigative centers).

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. The study evaluates the device's performance based on clinical measurements (e.g., TBUT, MGSS, OSDI, staining scores, temperature measurements) and adverse event reporting, rather than expert-established ground truth for an AI/ML diagnostic output.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. As this is not an AI/ML diagnostic device, an adjudication method for establishing ground truth from multiple expert interpretations would not be directly applicable in the same way.

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

Not applicable. The device is a thermal pulsation system for treating meibomian gland dysfunction, not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical medical device (thermal pulsation system), not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "clinical validation study" (thermal safety): The ground truth for temperature measurements was established using physical sensors (thermocouples) and an IR camera, directly measuring tissue temperatures.

For the "randomized clinical trial" ("OLYMPIA"): The "ground truth" for effectiveness and safety was established by direct clinical measurements and patient-reported outcomes, comparing the TearCare System to a predicate device (LipiFlow). This includes metrics like Tear Break-up Time (TBUT), Meibomian Gland Secretion Score (MGSS), Ocular Surface Disease Index (OSDI), corneal and conjunctival staining scores, meibomian gland function, adverse event reporting, pain/discomfort scores, visual acuity, and intraocular pressure.

8. The sample size for the training set

Not applicable. The described device is a physical medical device, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. The described device is a physical medical device, not an AI/ML system that requires a "training set."

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