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510(k) Data Aggregation
(323 days)
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
| Acceptance Criteria (Implicit from Clinical Study) | Reported Device Performance |
|---|---|
| Effectiveness Endpoints: | |
| 1. Statistically significant greater improvement from baseline in the average number of meibomian glands yielding clear liquid secretion at 2 weeks compared to Warm Compress Control. | Met, with a statistically significant (p<0.0001) greater improvement in the LipiFlow® group compared to the Warm Compress Control. |
| 2. Improvement in tear break-up time at 2 weeks from baseline with an effect greater than the Warm Compress Control. | Met, the LipiFlow® group showed a mean improvement in tear break-up time and a mean reduction in dry eye symptoms at 2 weeks from baseline with an effect greater than the Warm Compress Control. |
| 3. Reduction in dry eye symptoms (e.g., SPEED, OSDI) at 2 weeks from baseline with an effect greater than the Warm Compress Control. | Met, the LipiFlow® group showed a mean improvement in tear break-up time and a mean reduction in dry eye symptoms at 2 weeks from baseline with an effect greater than the Warm Compress Control. |
| 4. Sustained effectiveness (meibomian gland assessment, tear break-up time, dry eye symptoms) over a 4-week study duration. | Met, a single 12-minute treatment provided sustained effectiveness, on average, over the 4-week study duration, as shown by mean change in meibomian gland assessment, tear break-up time, and dry eye symptoms at 4 weeks from baseline. |
| Safety Endpoints: | |
| 1. Absence of device-related serious adverse events. | Met, no device-related serious adverse events reported. |
| 2. Absence of unanticipated adverse device effects. | Met, no unanticipated adverse device effects reported. |
| 3. Acceptable rate of device-related non-serious adverse events without sequelae or requiring medical treatment. | Met, four eyes (2.9%) in the LipiFlow® group had device-related non-serious adverse events (moderate eyelid pain, moderate conjunctival vascular injection). All resolved without sequelae or medical treatment within 4 weeks. Clinician concluded observed difference in device-related adverse events was not clinically significant. |
| Thermal Safety: | |
| Maximum corneal temperature not to exceed a specific threshold (implicitly related to the design goal of 42°C when accounting for insulation/cooling). | Maximum corneal temperature measured immediately after device treatment in human eyes in vivo reached 2000 C. Finite Element Analysis modeling predicted a maximum corneal temperature of C in worst-case conditions. The thermal safeguards ensure control of the heating element to ≤ 45°C. (Note: There appears to be a transcription error in the document, as 2000 C is not plausible. Assuming 40.0 C or similar was intended given the context of thermal safety and the 42°C design criteria.) |
| Biocompatibility: Meet ISO 10993 standards for contact materials. | Met, patient-contacting materials passed cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, implantation, and USP physiochemical tests. Materials are believed to be biocompatible. |
| Sterility: Achieve Sterility Assurance Level (SAL) of 10-6. | Met, sterilization process complies with ISO 11137-2:2006, achieving SAL of 10-6. |
| Shelf-life: Validate proposed 6-month shelf life. | Met, validated using accelerated aging tests (tensile strength, burst/creep pressure, dye penetration, bubble test). |
| Electrical/EMC Safety: Adhere to relevant IEC 60601 standards. | Met, device considered to adhere to IEC 60601-1 (1995), IEC 60601-1-2 (2001 & 2007). |
2. Sample Size and Data Provenance (for Clinical Study)
- Test Set Sample Size: 139 subjects (278 eyes) were enrolled.
- LipiFlow® group: 69 subjects (138 eyes)
- Warm Compress Control group: 70 subjects (140 eyes)
- Data Provenance: Not explicitly stated, but it was a multi-center study conducted at nine sites, implying domestic (USA) origin given the FDA de novo submission. The study was prospective, as subjects were randomized and followed after treatment.
3. Number of Experts and Qualifications for Ground Truth (Clinical Study)
- The document does not specify the number of experts used to establish the ground truth for the clinical study's outcome measures.
- The clinical study assessed effectiveness and safety parameters (Meibomian Gland Assessment, Tear Break-up Time, SPEED, OSDI, Discomfort/Pain, Ocular Surface Staining, IOP, Slit Lamp, Dilated Retinal Exam, BSCVA). These assessments would typically be performed by ophthalmologists or optometrists, but their specific qualifications (e.g., years of experience, subspecialty) are not detailed in the provided text. The "The clinician concluded the observed difference in device-related adverse events was not clinically significant" suggests expert clinical judgment was employed.
4. Adjudication Method (for Clinical Study Test Set)
- The document does not explicitly describe an adjudication method (like 2+1, 3+1) for the clinical study's outcome measures. Clinical studies of this nature often rely on standardized protocols for assessments and potentially independent review of adverse events, but a formal adjudication process for all endpoints is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- This study compared a device (LipiFlow®) to a control (warm compress therapy) for treating a medical condition (MGD). It did not involve comparing human readers' performance with and without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. Standalone Performance Study (Algorithm Only)
- No, a standalone (algorithm only) performance study was not done.
- The LipiFlow® System is a physical medical device that applies heat and pressure. It is not an AI algorithm or a diagnostic tool that would typically have a "standalone" algorithmic performance evaluation in the absence of a human operator, beyond its mechanical and electrical performance.
7. Type of Ground Truth Used (Clinical Study)
- The ground truth for the clinical study was established through objective clinical measurements and patient-reported outcomes, interpreted by clinicians.
- Objective Clinical Measurements: Meibomian Gland Assessment (yielding clear liquid secretion), Tear Break-up Time, Ocular Surface Staining, Intraocular Pressure (IOP), Slit Lamp and Dilated Retinal Exam, Best Spectacle Corrected Visual Acuity (BSCVA).
- Patient-Reported Outcomes: Standard Patient Evaluation of Eye Dryness (SPEED) and Ocular Surface Disease Index (OSDI) Dry Eye Questionnaires, Discomfort/Pain Evaluation.
- Expert Clinical Judgment: Interpretation of these measures and assessment of adverse events by clinicians.
8. Sample Size for the Training Set
- The document describes a clinical study that does not involve machine learning or AI algorithm development, and therefore, there is no "training set" in the context of data science. The clinical study serves as a validation and efficacy trial for the physical device.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an AI algorithm, this question is not applicable. The clinical study evaluates the device's direct therapeutic effectiveness and safety against a control group.
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