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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.

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The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

The Tixel i is intended to deliver heat and pressure to the eyelids of patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD). The Tixel i is comprised of a Console, which is connected via an umbilical tube to an applicator, referred to as "Handpiece."

The Handpiece includes a therapeutic element, the "Tip," fixated on its distal end. A clear polycarbonate illuminated Distance Gauge, mounted on the distal end of the Handpiece, covers the Tip and allows proper and safe positioning of the Handpiece on the skin prior to performing a treatment pulse. The Distance Gauge is removed only when the Tip is being cleaned.

The Tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. The active surface of the Tip consists of an array of 24 (6×4) square-based pyramids, evenly spaced. The pyramids have a blunt apex to allow effective heat transfer and prevent any risk of mechanical puncturing of the skin. The backplane of the Tip attaches to a ceramic heater that maintains a constant temperature during operation.

During a Tixel i procedure, an Aestek plastic ocular shield (Oculo-Plastik, Inc.) is to be inserted under the eyelids on the ocular surface to protect the eye during the procedure.

The FDA 510(k) summary for the Novoxel Tixel i device does not describe an AI/ML-driven device, but rather a medical device for treating dry eye disease. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices (e.g., number of experts, adjudication methods, MRMC studies, training/test set ground truth establishment, standalone performance) are not applicable here.

However, based on the provided text, I can infer the "acceptance criteria" through the study's primary and secondary endpoints for clinical performance and the non-clinical testing performed to ensure safety and functionality.

Here's an attempt to structure the information based on your request, adapting it to the nature of the device described:

Acceptance Criteria and Device Performance for Novoxel Tixel i (TXLI0001)

The Tixel i device is an eyelid thermal pulsation system indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD). Its acceptance criteria are primarily defined by its non-inferiority to a legally marketed predicate device (LipiFlow) in terms of clinical effectiveness and an acceptable safety profile.

1. Table of Acceptance Criteria and Reported Device Performance

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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.

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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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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.

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.

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The LipiFlow® Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve.

The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow® System is comprised of a physician interface (Control component labeled as "Console") and a patient interface (Disposable component labeled as "Activator II"). The Console provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids with the Activator II Disposable.

This 510(k) submission is for modification of the proposed Activator II Disposable (Model LFD-2100) and labeling changes to the predicate Activator II (Model LFD-2000). The proposed devices have the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device. The proposed Activator II Model (LFD-2100) is the same as the predicate Activator II Models (LFD-2000) except for the following:

• . Eye Cup Assembly Redesign: the Activator II eye cup, which consists of the bladder and substrate, will be redesigned to allow the eye cup to be manufactured as a single versus seven-piece molded bladder assembly while still attaching to the lid warmer in the same location.
• Back Surface Overmold Redesign: the back surface overmold of the lid warmer will be ● redesigned to accommodate the modified Single Piece Eye Cup. The design change will be limited to the removal of the t-extrusion in the Z-direction used to hold the original Eye Cup in position.
• The material for the non-patient contact bladder substrate will be changed from Valox (PBT) to polycarbonate.

The labeling for the predicate Activator II Model (LFD-2000) will also be updated to replace special storage and handling conditions with the statement: "Store at room temperature".

Compared to the predicate Activator II Model, the patient interface portion of the proposed Activator II Model is identical in patient-contact materials, electrical safety, packaging, sterility, shelf-life, method of preventing re-use, and temperature and pressure performance and safety. The proposed Activator II Model (LFD-2100) will remain fully backwards compatible with the current LipiFlow Console and Semi-permanent Cable. There are no changes to the Console and Cable from the predicate device.

The provided text describes a 510(k) submission for modifications to the LipiFlow® Thermal Pulsation System, specifically the Activator II Disposable (Model LFD-2100) and labeling changes to the existing Model LFD-2000. The submission argues for substantial equivalence to a legally marketed predicate device (LipiFlow® Thermal Pulsation System cleared under K161357).

The key point is that this submission focuses on modifications to an existing device and its equivalence to a predicate, rather than presenting a de novo study with novel acceptance criteria for a new device's clinical performance. Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating that the modified device maintains the safety and effectiveness of the predicate device, especially regarding its physical and performance characteristics, rather than establishing efficacy for a new clinical endpoint.

Here's a breakdown of the information based on your request, with the caveat that many aspects (like human reader studies, ground truth for training) are not applicable or explicitly mentioned for a 510(k) modification submission of this nature.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the existing performance standards and specifications of the predicate device. The performance testing aims to demonstrate that the modified device (LFD-2100) and the updated predicate (LFD-2000) meet these same standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The type of testing described (electrical safety, EMC, temperature/pressure performance, sterility, shelf-life, biocompatibility) typically involves testing a certain number of manufactured units or batches, rather than a "test set" of clinical data in the way one would for an AI algorithm. The document states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the predicate device."
• Data Provenance: Not applicable in the context of clinical data for a study. The "data" here comes from bench testing of the modified device components themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission concerns device hardware and labeling modifications, and the "ground truth" is defined by established engineering and regulatory performance standards (e.g., electrical safety standards, temperature specifications, material biocompatibility). There is no "ground truth" derived from expert clinical assessment for this type of submission.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this type of submission.

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. This is not an AI/software device submission focusing on diagnostic performance or human reader improvement.

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

Not applicable. This is not an AI/software device submission.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering specifications, performance standards (e.g., ISO, IEC for electrical safety), and regulatory requirements for biocompatibility, sterility, and shelf-life. It is not expert consensus, pathology, or outcomes data, as those apply to clinical efficacy or diagnostic performance.

8. The Sample Size for the Training Set

Not applicable. There is no AI component or "training set" for this hardware modification submission.

9. How the Ground Truth for the Training Set was Established

Not applicable. (See #8)

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The iLux System is indicated for the application of localized heat and pressure therapy in adult patients with chronic diseases of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye.

The iLux System is a medical device intended for use by Licensed Eye Care Professionals (ECP) to apply localized heat and pressure therapy to adult patients' lower and/or upper eyelids. The il.ux System consists of a hand-held Instrument coupled to a single-use sterile Disposable component that is positioned behind the eyelid. The iLux System allows the ECP to view the eyelid margin through a magnifier, then warm the eyelid tissue to a target range of 40 to 42 °C to melt the meibum blocking the gland orifices and then apply compression to the eyelid to express the melted meibum through the orifices. The inner eyelid temperature and the amount of force applied to the eyelid are both displayed on the Instrument allowing the clinician to titrate the ideal amount of heating and compression to optimize unclogging of the blocked glands.

The Disposable is a sterile, single-use component that is attached to the iLux Instrument. It includes all parts intended to contact the patient's eyelid.

The iLux Instrument is a handheld device that allows the ECP to view, heat, and compress the portion of the eyelid that is in contact with the Disposable. The source of heating is lime-green and infrared optical radiation produced by LEDs in the Instrument. The ilux Instrument is powered by a rechargeable lithium ion battery. The software Level of Concern is Moderate.

Ancillary accessories include the charging stand with AC power supply.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate table. Instead, it details that the iLux System was studied for non-inferiority against the predicate device (LipiFlow System) for specific effectiveness and safety endpoints. The "reported device performance" are the findings from this non-inferiority study.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 142 subjects (284 eyes). The subjects were randomized into two treatment groups (iLux vs. LipiFlow) in a 1:1 ratio.
• Data Provenance: The study was a clinical study, implying prospective data collection. The document does not specify the country of origin, but it was submitted to the U.S. FDA, so it's likely a study conducted in the U.S. or under international standards acceptable to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical study endpoints (Meibomian Gland Score, Tear Break-Up Time, Ocular Surface Disease Index, pain/discomfort scores, adverse events, etc.). These metrics are typically assessed by trained clinical personnel (e.g., ophthalmologists, optometrists, or research coordinators) according to standardized protocols.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study endpoints. The assessment of endpoints like MGS, TBUT, OSDI, and adverse events would typically follow pre-defined protocols and may involve single assessors or dual assessments with a consensus process, but this is not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Human-in-the-loop/MRMC study was not performed, nor was it relevant for this device. The iLux System is a therapeutic device that applies heat and pressure, not a diagnostic AI system requiring human interpretation. The study was a direct comparison of the therapeutic effect of the iLux device versus a predicate device, each operated by a licensed eye care professional.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

Not applicable/Not done. The iLux System is a medical device operated by a Licensed Eye Care Professional for treatment. It is not an imaging analysis algorithm or a diagnostic tool that operates independently to provide "standalone" performance. Its "performance" is its therapeutic efficacy when used by a human operator, which was assessed in the clinical study.

7. Type of Ground Truth Used:

The "ground truth" for the clinical study was established through:

• Clinical Endpoints/Measurements: Meibomian Gland Score (MGS), Tear Break-Up Time (TBUT), Ocular Surface Disease Index (OSDI), pain scores, discomfort scores, ocular surface staining, Intraocular Pressure (IOP), and Best Spectacle Corrected Visual Acuity (BSCVA). These are objective and subjective measurements commonly used in ophthalmology to assess the condition of the eyes and patient well-being for MGD.
• Adverse Event Reporting: Direct observation and patient reporting of any device/procedure-related adverse events.

8. Sample Size for the Training Set:

Not applicable/Not mentioned. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. It's a physical medical device. The "training" for the device would involve training the eye care professionals on how to use it.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not mentioned. As there's no data-driven "training set" for an AI algorithm, this question is not relevant to the iLux System.

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The LipiFlow® Thermal Pulsation System is intended for the application of localized heat and pressure therapy 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 LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow® System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Control component (labeled as Console) provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Disposable component (labeled as Activator).

This 510(k) submission is for the device modification of new model of the Disposable component (labeled Activator II, Model LFD-2000), a new semi-permanent Cable (Model CBL-2000), and a hardware and software update to the Control component (labeled as Console, Model LFTP-1000). The modified LipiFlow® System has the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device.

The provided text describes a 510(k) premarket notification for a modified version of the LipiFlow® Thermal Pulsation System. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy with novel acceptance criteria and studies demonstrating the device meets those criteria.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance (in the context of new clinical endpoints).
• Sample sizes for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth for a test set in the context of proving new performance claims.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of human readers with/without AI assistance.
• Standalone algorithm performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for novel clinical claims.
• Sample size for training sets.
• How ground truth for training data was established.

Instead, the document focuses on demonstrating that the modified LipiFlow® System (specifically, changes to the disposable component, a new cable, and hardware/software updates to the console) is substantially equivalent to the predicate LipiFlow® System.

Here's what the document does provide regarding performance testing and conclusions:

Acceptance Criteria and Device Performance (in the context of substantial equivalence):

The performance testing focused on demonstrating that the modified device maintained the same safety and effectiveness as the predicate device, conforming to special controls. Instead of "acceptance criteria" in the sense of novel clinical endpoints, the "criteria" are essentially the established performance and safety profiles of the predicate device and relevant standards.

Study Information Pertaining to Substantial Equivalence:

• Study Type: The document describes "performance testing" rather than a clinical trial with novel efficacy endpoints. This testing aimed to demonstrate that the modifications did not alter the safety or effectiveness profile previously established for the predicate device.
• Sample Sizes / Data Provenance / Ground Truth / Experts / Adjudication: These details are not provided because the submission is for device modification and substantial equivalence, not a new clinical efficacy study. The "ground truth" for the performance comparisons is implicitly the established performance of the predicate device and relevant industry standards.
• MRMC / Standalone AI Performance: Not applicable, as this is not an AI/algorithm-focused submission. The device is a physical thermal pulsation system.
• Training Set Sample Size/Ground Truth: Not applicable for this type of submission. The performance testing is about ensuring the modified device operates to the same specifications as the predicate. The "ground truth" for the predicate device's efficacy was established through previous bench, animal, and clinical studies, but details of those studies are not provided here.

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The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy 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 LipiFlow Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic neibomian glands. The LipiFlow System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Console (Control component) provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Activators (Disposable component). No changes to the Console are proposed in this 510(k). The Activator (Disposable) is a sterile; single-use. biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's eyelids. The Activator (Disposable) consists of a combined eye cup and lid warmer with attached tubing and wiring that connect to the Console with a connector. There are two models of the Activator (Disposable). Except for the addition of a memory device, Activator (Disposable) Models LFD-1000 (cleared under K093937) and LFD-1100 (modified under design controls) are equivalent with no difference in device performance, safety or effectiveness. This 510(k) submission is for a device modification of new materials for the LipiFlow Activator (Disposable). The proposed changes to the Activator (Disposable) are to provide a second source for the raw materials used in the eyecup bladder (diaphragm), lid warnier glue and heater components to facilitate manufacturing. The model numbers of the Activator (Disposable) will not change as a result of this change. The LipiFlow Activator (Disposable) with the new second source materials has the same intended use and same fundamental scientific technology as the predicate cleared device (LipiFlow® Activator (Disposable) with cleared materials, as described in K093937 and K.I. 2704). Accordingly, this 510(k) submission for a design change to use second source new materials in the Activator (Disposable) applies to both model numbers (LFD-1000 and LFD-1100) of the Disposable component.

Below is a description of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance Study for LipiFlow® Thermal Pulsation System (K133127)

This 510(k) submission (K133127) describes a device modification involving new materials for the LipiFlow Activator (Disposable) component. The primary objective was to demonstrate that these material changes do not adversely affect the safety and effectiveness of the device, maintaining substantial equivalence to the predicate devices (K093937 and K112704).

1. Table of Acceptance Criteria and Reported Device Performance

The performance testing focused on demonstrating conformance to special controls for an eyelid thermal pulsation system per 21 CFR 886.5200.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily describes bench testing for design verification and validation of the material changes. There is no information provided regarding a specific "test set" of patient data or sample size in terms of human subjects for this 510(k) submission (K133127). The evaluation focused on engineering and material performance rather than clinical performance on a new patient cohort.

The data provenance for the original safety and effectiveness of the LipiFlow System (K093937 and K112704) involved "bench, animal and clinical studies." However, the details of these are not provided within this specific document, and they pertain to the predicate device, not directly to the current material modification under K133127.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission concerns material modifications evaluated through bench testing and engineering verification/validation, not a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set data was used for this specific 510(k) given the nature of the device modification (material change).

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 LipiFlow System is a medical device for localized heat and pressure therapy, not an AI-powered diagnostic imaging or interpretation tool that would involve human readers or AI assistance.

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

Not applicable. The LipiFlow System is a physical device that performs a therapeutic action, not an algorithm. Performance was evaluated through the device's adherence to its operational specifications and safety parameters.

7. The Type of Ground Truth Used

For the material modifications in K133127, the "ground truth" was established based on:

• Engineering specifications and design requirements: The new materials needed to meet the same physical, electrical, and performance specs as the original materials.
• Biocompatibility standards: The new patient contact materials had to meet established biocompatibility requirements.
• Safety standards: The device operating with new materials had to pass tests ensuring all safety safeguards (temperature, pressure) function correctly, even under fault conditions.

For the original LipiFlow System's safety and effectiveness (predicate device), the ground truth was established through "bench, animal and clinical studies" (as referenced in K093937 and K112704), which would have involved clinical outcomes and possibly expert assessment for efficacy, and direct measurement for safety parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The "training" for the device's performance would be the extensive design, engineering, and testing processes to ensure it meets its predefined specifications.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is not an AI/machine learning device with a training set. The "ground truth" for the device's design and operational parameters was established through established engineering principles, regulatory standards, and clinical validation studies for the original device.

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The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic condictions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent prossure the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow System is comprised of physician interface (Control component) and a patient interface (Disposable component). There are two models of the Control component: Model LFH-1000, Handheid Control System (HCS) and Model LFTP-1000, Console. The Console is a rhange in design from the HCS predicate device model. The LipiFlow® Console was developed fring the same treatment control technology as in the LipiFlow® FICS with enhancements in the user interface and power source. Both the Console and HCS work with the same Disposable component (Model LFD-1000), now labeled as Activator (Disposable).

The Activator (Disposable) is a sterile, single-use, biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's cyelids. The Activator (Disposable) consists of a combined eye cup and lid warmer with attached tubing and wiring that connect to the Console with a connector.

The Console is an AC-powered, bench-top device used by the physician to control the application of heat and pressure to the patient's eyelids. The Console consists of a Windows XP embedded computer subsystem with touchscreen display and a software graphical user interface; and treatment hardware for treatment of the patient's right and left eyes using two Activators (Disposables). The Console provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Activators (Disposables).

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Preamble:

It's important to note that this document is a 510(k) summary for a premarket notification, where the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device. As such, the "study" described is primarily focused on demonstrating that a new model (LipiFlow® Console, Model LFTP-1000) is equivalent to a predicate model (LipiFlow® HCS, Model LFH-1000) and meets existing safety and performance standards for Eyelid Thermal Pulsation Systems. It's not a clinical trial establishing efficacy against a placebo or a direct standalone performance study in the way one might expect for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for specific tests (e.g., a "test set" in the context of AI/ML). The performance testing described is primarily bench performance testing and software verification/validation.
  • For the "direct comparison during treatment of human eyelids" for temperature and pressure performance, the number of human eyelids or subjects tested is not specified.
• Data Provenance: The studies mentioned for the predicate device (K093937) included "bench, animal and clinical studies." For the current submission, the testing type described is predominantly bench testing and software validation. There is no mention of country of origin, retrospective or prospective data collection specifically for this K112704 submission, beyond referencing the predicate's studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This documentation does not describe a traditional "test set" with ground truth established by experts in the context of classification or diagnostic performance (as one might find for an AI/ML diagnostic device).
• The criteria are technical performance specifications (e.g., temperature accuracy, pressure consistency, electrical safety, software function). The "ground truth" here is adherence to engineering specifications, regulatory standards (e.g., 21 CFR 886.5200, electrical safety, EMC), and equivalence to the predicate device's proven performance.
• The "experts" involved would implicitly be the engineers, software developers, and quality assurance personnel performing the verification and validation, as well as the regulatory reviewers at the FDA. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Not applicable in the typical sense of expert adjudication for diagnostic accuracy. The testing described focuses on engineering performance, software validation, and comparison to a predicate device's established specifications. The "adjudication" would be a determination of whether the device meets the predefined technical and regulatory acceptance criteria.

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

• No MRMC comparative effectiveness study was done. This device is a therapeutic device (applying heat and pressure), not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical therapeutic system with an operator (physician) in the loop, administering the treatment. While it has software, that software controls the hardware's treatment parameters, it does not function as a standalone diagnostic algorithm. The software is part of the overall system's function, not a separate "algorithm only" component. The document explicitly states: "Additionally, the Console's software does not control treatment, and a software failure would not affect the hardware's treatment control or the safety circuits." This implies the critical treatment control is hardware-based, with software for user interface, monitoring, and secondary functions.

7. The Type of Ground Truth Used

• For the current submission (K112704), the "ground truth" is primarily based on:
  • Engineering Specifications: Adherence to defined temperature, pressure, electrical, and mechanical criteria.
  • Regulatory Standards: Conformance to relevant national and international standards (e.g., electrical safety, EMC, biocompatibility).
  • Predicate Device Performance: Demonstrating substantial equivalence to the established safety and effectiveness profile of the predicate device (LipiFlow® HCS, K093937), which itself relied on prior "bench, animal and clinical studies."
  • Design Input Requirements and User Needs: For software validation.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set in the conventional sense for a diagnostic algorithm. The device's operational parameters (temperature, pressure profiles) were established through prior engineering design, bench testing, animal studies, and clinical studies for the predicate device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. Since there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The functional "ground truth" for the device's therapeutic parameters was established through the design and testing processes of the original predicate device, validated through various studies (bench, animal, clinical) to be safe and effective.

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