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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 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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