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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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LipiScan™ Dynamic Meibomian Imager is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

The LipiScan™ Dynamic Meibomian Imager (DMI) (Model DMI-1000) is a bench-top ophthalmic camera used to image the meibomian glands. LipiScan™ contains a computer system, electronics, chin and forehead rest, camera and attached lens, illuminator, touchscreen display, handheld near-infrared (IR) lid everter and power supply. The chin and forehead rest and handheld near IR lid everter are the only components of the device that contact the patient's intact skin. LipiScan™ uses near infrared (NIR) illumination and an NIR-sensitive high-resolution camera to image the meibomian glands. The tissue between the meibomian glands and the surface of the eyelid is transparent to NIR light; the glands reflect NIR wavelengths, allowing them to be imaged. The images of the glands may be viewed on the computer screen display and in a printed report.

The provided text is a 510(k) Summary for the LipiScan™ Dynamic Meibomian Imager. It primarily focuses on demonstrating substantial equivalence to a predicate device (LipiView® II Ocular Surface Interferometer) rather than presenting a standalone study with specific acceptance criteria and detailed performance data against those criteria.

However, based on the information provided, I can infer the implied acceptance criteria, the general type of "study" conducted (performance testing to demonstrate substantial equivalence), and some details about the testing:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria and a direct performance table are not provided in the 510(k) summary, the acceptance criteria are implicitly defined by compliance with relevant standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is described in terms of meeting these standards and having equivalent functionality for its specific indications.

• ANSI AAMI ES60601-1 2005 /(R)2012 and A1:2012: C1:2009/(R)2012 and A2:2010/(R)
• IEC 60601-1-2 2007 |
  | Light Hazard Protection | Conformance to specified light hazard protection standards, indicating no potential light hazard. | "LipiScan™ DMI meets Group 1 ophthalmic instruments as defined in the ISO 15004-2: 2007 and ANSI Z80.36:2016 standards for which no potential light hazard exists." (Note: Predicate meets Group 2, implying a higher hazard, but this difference for LipiScan is presented as a positive, not a deviation needing further evaluation). |
  | Software | Software performance complies with specifications and requirements, and it is categorized as a Minor Level of Concern. | "Verification and Validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the LipiScan™ DMI software." "As for the predicate device, LipiScan™ DMI software is categorized as a Minor Level of Concern." |
  | Imaging Functionality | Able to capture, archive, manipulate, and store digital images of the meibomian glands using NIR illumination. (Implied by the "Indications for Use" and "Technological Characteristics" sections). | Demonstrated through "Performance testing" and the comparison to the predicate, stating it has "the same principle of operation as an ophthalmic camera to image the meibomian glands using a LED light source in the near-infrared spectrum." The software features for real-time display, image storage, and export also confirm this functionality. Additionally, "Methods are equivalent. Motorized stages are not needed to capture and focus an image using LipiScan™, as shown by performance testing." indicating functionality. |

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

The document does not explicitly state the sample size used for any specific "test set" in the context of clinical performance or image analysis. The "performance testing" mentioned generally refers to design verification and validation, usability testing, and bench testing against standards.

The data provenance for any potential clinical images used in "performance testing" is also not specified. It is likely that such testing would involve capturing images from human subjects, but the details (e.g., country of origin, retrospective or prospective) are absent.

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

The document does not mention using experts to establish ground truth for a test set. This type of analysis (e.g., grading of meibomian gland images by experts) is not described in detail as part of the substantial equivalence claim.

4. Adjudication Method for the Test Set

Since the document does not describe the use of experts or a specific test set for diagnostic performance, an adjudication method is not mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned in the document. The filing focuses on demonstrating substantial equivalence of the device's functionality and safety characteristics to a predicate, not on improving human reader performance with AI assistance.

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

No standalone algorithm performance study is explicitly described. The device is an "ophthalmic imaging device intended for use by a physician... to capture, archive, manipulate and store digital images." While it uses software, the primary evaluation is of the device's ability to acquire and manage images, rather than an AI algorithm making diagnostic decisions or segmentations independently. The software evaluation is focused on compliance with specifications and requirements, not standalone diagnostic performance.

7. The Type of Ground Truth Used

Given the nature of the device (an imager) and the focus on substantial equivalence for technical characteristics and image acquisition, the "ground truth" implicitly refers to:

• Compliance with engineering and safety standards: The device passes tests against established standards for electrical safety, EMC, light hazard, and material flammability (e.g., ANSI, ISO, IEC, UL standards).
• Functional equivalence to the predicate: The LipiScan™'s ability to capture images of meibomian glands is considered equivalent to the predicate device's capability, which serves as the established gold standard for this function.
• Successful software verification and validation: The software performs according to its designed specifications.

8. The Sample Size for the Training Set

The document does not mention any training set size, as it does not describe the development or evaluation of a machine learning or AI algorithm that would typically require a training set for diagnostic or analytical tasks. The software development was largely based on existing software from the predicate device.

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

As no training set is mentioned in the context of an AI/ML algorithm, the method for establishing ground truth for a training set is not applicable/not 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 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 LipiView® II Ocular Surface Interferometer is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of:
• Specular (interferometric) observations of the tear film. Using these images, LipiView® II measures the absolute thickness of the tear film lipid layer.
• Meibomian glands under near-infrared (NIR) illumination
• The ocular surface and eyelids under white illumination
All of these image types can be photographically documented and visually monitored.

The LipiView® II Ocular Surface Interferometer is a bench-top device used as an ophthalmic camera for imaging the lipid layer of the tear film, meibomian glands, ocular surface and eyelids. There are three imaging modes: Lipid, Gland and Ocular. LipiView II contains a computer system and electronics, two position chin and forehead rest, camera and lens, motion stage, illuminator and touch screen display. LipiView II includes pushbutton controls and handheld near-infrared lid everter for gland imaging.

The provided document is a 510(k) summary for the LipiView II Ocular Surface Interferometer. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria and performance data from a specific clinical study for the device's diagnostic or predictive capabilities.

The document states that "Performance testing demonstrates that the design changes in LipiView II do not raise new questions of safety and effectiveness, and LipiView II is substantially equivalent to the predicate devices." It also mentions usability testing and software validation. However, it does not provide quantitative acceptance criteria or detailed results from a study that "proves the device meets the acceptance criteria" in terms of clinical accuracy (e.g., sensitivity, specificity, agreement with a gold standard).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance in a clinical context.
2. Sample size used for the test set and the data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set.

The document describes the device's technological characteristics, its intended use (imaging the tear film, meibomian glands, ocular surface, and eyelids), and how it compares to predicate devices. It emphasizes safety and effectiveness through compliance with standards (e.g., ISO, ANSI/IEC for light hazard, electrical safety, EMC, material flammability) and through the absence of new safety or effectiveness questions based on design changes.

Summary of what is present in the document regarding "performance testing":

• Usability testing and software validation: These were done to demonstrate that LipiView II is as safe and effective as predicate devices for its intended use.
• Compliance with standards: The device meets standards for light hazard protection (ISO15004-2), electrical safety (ANSI/IEC 60601), electromagnetic compatibility (EMC), and material flammability (UL 94V-1). The use of NIR illumination "does not raise new safety or effectiveness questions."
• Hardware features: New hardware features (two-position chin rest, high-definition camera, NIR illumination, handheld NIR lid everter) "meet all design requirements for safety and performance, and therefore, do not adversely affect safety and effectiveness."

In conclusion, this document primarily asserts that the device's performance, particularly regarding safety and technological characteristics, is substantially equivalent to its predicate devices, rather than providing a detailed report of clinical study acceptance criteria and results for diagnostic performance.

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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 LipiView® Ocular Surface Interferometer is intended to image the tear film. The LipiView® Interferometer is a prescription device for use by a physician during an in-office exam.

Indications for Use: The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView Interferometer measures the absolute thickness of the tear film lipid layer.

The LipiView Ocular Surface Interferometer is a bench-top imaging device containing a computer system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator and a touch screen display. The LipiView® Interferometer operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The computer system captures a video image file that is recorded over time since the interference pattern changes as the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display, in a printed report, or captured on video and exported to USBattached storage or a mapped network drive.

The LipiView® Interferometer has been modified to software version 2.0, which includes changes to refine the interferometric color matching and blink detection methods used on interferometric images and to provide minor usability enhancements.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the LipiView® Ocular Surface Interferometer with software version 2.0:

Acceptance Criteria and Device Performance

The provided document details performance testing for hardware changes and software version 2.0. The acceptance criteria are implicitly derived from the successful outcomes of these tests, demonstrating substantial equivalence to the predicate device and validation for the expanded indications.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a series of performance tests rather than a single, unified study with a specific name. The primary focus of the testing was to demonstrate substantial equivalence to the predicate device and to validate the expanded indication for tear film lipid layer thickness measurement.

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

   • Test Set Description: The document refers to testing with "physical phantoms representative of the pre-corneal tear film of a known thickness." It also mentions "in vivo device measurement variability" testing.
   • Sample Size: The exact sample size for the phantom testing or in vivo variability testing is not specified in the provided text.
   • Data Provenance: The data appears to be prospective as it was generated specifically for the verification and validation of the device with software version 2.0. The country of origin of the data is not specified, but given the applicant and contact person's location in Morrisville, NC, USA, it is highly likely the testing was conducted in the US.

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

   • For the physical phantoms, the ground truth was established by independent ellipsometry measurements, which is an objective physical measurement technique, not by human experts.
   • For aspects like "correctly identified valid blink frames," it is implied that a ground truth was used for comparison, but the number and qualifications of experts involved in establishing this ground truth are not specified.

3. Adjudication Method for the Test Set:

   • Given that the ground truth for lipid layer thickness measurement was established by independent physical methods (ellipsometry) and blink detection likely involved an objective standard for "valid blinks," a human adjudication method like 2+1 or 3+1 is not described and likely not applicable in the traditional sense for these specific tests.

4. 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, an MRMC comparative effectiveness study is not described or implied. This device is an imaging and measurement tool for tear film, not a diagnostic aid that assists human readers in interpreting complex images. The focus is on the device's ability to accurately measure and provide data, rather than on improving human reader performance.

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

   • Yes, standalone performance testing was done. The core "performance testing" described directly assesses the algorithm's ability to measure tear film lipid layer thickness using phantoms and its blink detection capabilities, independent of real-time human interaction. The reported measurement variability and blink detection improvements are measures of the algorithm's standalone performance.

6. The Type of Ground Truth Used:

   • For the lipid layer thickness measurement, the ground truth was objective physical measurement by ellipsometry on physical phantoms of known thickness.
   • For blink detection, the ground truth source is not explicitly stated but would likely be a predefined objective standard for "valid blink frames."

7. The Sample Size for the Training Set:

   • The document does not provide any specific sample size for a training set. It mentions the interferometric color palette was "developed and validated to a known standard," which implies a development process that might involve an internal dataset, but no details are given. The nature of the device (improving an existing physical measurement method) suggests it might not rely on a large, labeled training set in the same way machine learning-based diagnostic algorithms do.

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

   • Given that no training set sample size is provided, the method for establishing ground truth for a training set is not described. If "developed to a known standard" refers to an internal process, the ground truth would likely be based on objective physical measurements (similar to the test set ground truth) or carefully defined criteria for blinks.

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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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The LipiFlow® 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 physician uses the LipiFlow® System in an in-office procedure to control the application of warmth and massage to the eyelids. Two components comprise the LipiFlow® System, the Disposable unit and the Handheld Control System (HCS). The Disposable unit is a sterile, single-use, biocompatible unit that is inserted around the patient's eyelids. The Disposable unit consists of a combined Eye Cup and Lid Warmer with attached tubing and wiring that connect to the Control unit with a connector. The Eye Cup contacts the outer eyelid and contains a soft, flexible bladder that intermittently inflates with air to provide controlled massage pressure to the eyelids. The Lid Warmer contacts the inner eyelid surface and provides controlled, outward directional (away from the eye and towards the eyelid) heat to the inner eyelid. The Lid Warmer has a smooth surface and edges, where the circumference rests lightly on the conjunctiva of the eye. The Lid Warmer shape vaults above the eye surface to prevent corneal contact. The Lid Warmer has an integrated insulator (also referred to as the Insulating Scleral Lens) to shield the eye from thermal transfer and redundant temperature sensors to ensure precise control of the temperature. The HCS is a battery-operated, hardware interface that allows the physician to control the application of heat and pressure, which is delivered via a single, 12-minute treatment. The HCS regulates the level of heat and pressure that can be applied during treatment. The HCS consists of a visual Light Emitting Diode (LED) display, power switch, push button, electronic circuit board, pump, pressure regulator, pressure sensor, dump valve, connector and battery compartment. The HCS displays information to the physician including: the temperature at the Disposable; line air-pressure to the Disposable; treatment time; low pressure selection indicator; and system messages, such as low battery, a system error, or inadequate connection to the Disposable. By visualizing the temperature and pressure LED displays, the physician can determine when the therapeutic temperature is reached and the relative pressure being applied. The push button starts the application of heat and pressure and can be depressed again at any time to pause the treatment, which immediately stops the therapeutic application. In the event that the physician desires to reduce pressure for patient comfort, the pressure can be reduced by 30% (Low Pressure Mode) by pressing and holding the push button. The HCS uses three AA (1.5V) Lithium disposable batteries.

The provided text describes the regulatory information, device description, nonclinical/bench studies, animal study, electrical/mechanical/thermal safety, and a clinical study for the TearScience, Inc. LipiFlow® Thermal Pulsation System. However, it does not contain explicit "acceptance criteria" in a tabulated format or detailed "reported device performance" against such criteria. The clinical study details describe effectiveness parameters and safety parameters, which serve as an implicit set of criteria for the device's performance and safety.

Based on the provided information, here's a structured response:

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

Note: The document does not explicitly list "acceptance criteria" in a table format. The table below synthesizes the primary effectiveness and safety outcomes from the clinical study as the implicit acceptance criteria, and reports the device's performance against them.

1. Table of Acceptance Criteria and Reported Device Performance

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The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

The LipiView® Ocular Surface Interferometer is a bench-top imaging device containing a computer system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator and a touch screen display. The LipiView® Interferometer operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The computer system captures a video image file that is recorded over time since the interference pattern changes as the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display and in a printed report.

The provided 510(k) summary for the LipiView® Ocular Surface Interferometer (K091935) does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in terms of clinical performance or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and compliance with relevant safety and manufacturing standards.

Here's an analysis based on the provided text, highlighting the absence of information where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not include a table of specific acceptance criteria related to a clinical performance study (e.g., sensitivity, specificity, accuracy for a particular clinical task) nor does it report such performance metrics. The "performance testing" mentioned refers to compliance with safety and manufacturing standards.

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

No specific test set or clinical study data is provided in the document from which to derive a sample size or data provenance. The submission focuses on device design and comparison to predicate devices, not a clinical performance evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Since no clinical performance study or test set data is provided, there is no mention of experts establishing ground truth for such a study.

4. Adjudication Method

Not applicable. Since no clinical performance study or test set data is provided, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on technological characteristics and safety standards, rather than a clinical trial comparing device performance with and without AI assistance or against human readers.

6. Standalone Performance Study (Algorithm Only)

The device described is an "Ocular Surface Interferometer," an imaging device. While it contains computer software, the provided summary does not detail any standalone algorithmic performance (e.g., automated disease detection, quantification of a specific biological marker) that would necessitate a standalone performance study in the way modern AI/ML devices often do. Its intended use is to capture, archive, manipulate, and store digital images for visual monitoring and documentation by a physician.

7. Type of Ground Truth Used

Not applicable. As no clinical performance study is detailed, no specific ground truth (expert consensus, pathology, outcomes data) is discussed for such a study.

8. Sample Size for the Training Set

Not applicable. The document does not describe the development of an AI/ML algorithm that would require a training set in the conventional sense. The "software was developed and tested in compliance with FDA Guidance documents for software validation in medical devices," which refers to general software engineering principles, not necessarily AI model training.

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

Not applicable. As no AI/ML algorithm requiring a training set is described, no ground truth establishment method for a training set is mentioned.

Conclusion based on the provided document:

The 510(k) submission for the LipiView® Ocular Surface Interferometer (K091935) relied primarily on demonstrating substantial equivalence to already cleared predicate devices by comparing their intended use, technological characteristics, and compliance with applicable safety and manufacturing standards. It does not present detailed clinical acceptance criteria or a study focused on clinical performance metrics like diagnostic accuracy, sensitivity, or specificity for a particular clinical condition. The "performance testing" cited pertains to engineering and safety standards, not clinical effectiveness.

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