(208 days)
The AUTOLENS ® Automatic Contact Lens Cleaning Accessory is indicated for the cleaning of soft (hydrophilic), rigid gas permeable (RGP) and hard (PMMA) contact lenses when used with AUTOLENS® Multipurpose Solution. This automatic contact lens cleaning accessory cleans contact lenses without digital rubbing. The AUTOLENS® Automatic Contact Lens Cleaning Accessory may be used as a receptacle for chemical disinfection with AUTOLENS® Multipurpose Solution.
AUTOLENS® Multipurpose Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro-silicone acrylate and silicone acrylate) and PMMA contact lenses as recommended by your eye care practitioner.
The device is a holder, cleaning and disinfection system for contact lenses. It consists of a contact lens holder, bottle, cap and base. A separate battery operated tumbler device is integral to the system. It is designed to slowly tumble the bottle assembly including contact lens solution to effect cleaning of contact lenses.
The lens holder is a single piece molded plastic device including hinged snap closure covers to contain each contact lens separately. An easily identifiable, raised letter "R" and "L" is included adjacent each closure receptacle to allow clear identification for right and left contact lenses placed within the lens holder. The lens holder contains openings to sufficiently allow the free flow of solution to circulate on all surfaces of the contact lens during the cleaning process.
The bottle is made of molded plastic and is of oval shape to facilitate the flow of solution over the lens holder and lenses during operation. The bottle is of sufficient size to contain the lens holder and 8 ml. of contact lens solution to cover the contact lenses at all times during operation and storage. The bottle is designed to hold the contact lens holder securely to ensure its rotation as the bottle spins during operation. The bottle is designed with a fluid-tight, screw closure cap. The lens holder, bottle, cap and base are made of polypropylene resin plastic.
The tumbler device is a battery powered unit operating at 1.5 volts utilizing three "AA" batteries. A plastic housing is molded to contain a small electrical motor, tumbler drive, on/off switch, batteries and a battery door to easily replace batteries. A cradle is molded within the shape of the housing to contain the assembled lens holder bottle. The drive shaft is connected to the motor inside the base housing.
When the device is turned on at the switch, the battery operated electrical motor turns the extended drive shaft. The bottle assembly resting upon the drive shaft turns in unison. The mechanical action of the bottle assembly on the drive shaft provides for a rotation of approximately 10 RPM.
The AUTOLENS® System, which includes the AUTOLENS® Automatic Contact Lens Cleaning Accessory and AUTOLENS® Multipurpose Solution, aims to provide an automatic method for cleaning, rinsing, and disinfecting contact lenses. The device's acceptance relied on demonstrating its effectiveness and safety through bench testing.
Here's a breakdown of the acceptance criteria and the study that addressed them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: No adverse reactions (cytotoxicity, ocular irritation, systemic toxicity) from contact with plastic components. | A battery of toxicology tests (Cytotoxicity, Ocular Irritation, Systemic Toxicity) were conducted on the plastic components. The results did not indicate any response that would raise concern regarding the safety of the components for biocompatibility when tested in laboratory animals. |
| Solution Stability (pH): The pH of the multipurpose solution should remain stable over the recommended 4-hour soak-time for cleaning, indicating no degradation or alteration by the device. | A bench testing protocol measured the pH of the solution at the start and completion of the 4-hour procedure. In all three test devices, the final pH was the same as the initial pH, concluding that no change in solution pH was witnessed during operation. |
| Solution Stability (Temperature): The device should not cause a significant temperature increase in the multipurpose solution during operation that would compromise the stability of the cleaning and disinfection solution. | A bench testing protocol measured the temperature at the start and completion of the 4-hour procedure. The results indicated that the temperature rise was minimal. |
| Compatibility with Wetting Drops: The AUTOLENS® Brand MULTI-PURPOSE Solution should be compatible with recommended wetting drops, with no precipitate formation. | Additional compatibility testing for recommended wetting drops and the AUTOLENS® Brand MULTI-PURPOSE Solution was conducted. The results indicate that the solutions were deemed compatible and without precipitate formation. |
| Cleaning Effectiveness (without digital rubbing): The device, when used with AUTOLENS® Multipurpose Solution, should effectively clean contact lenses automatically without the need for digital rubbing or manual hand cleaning. (This is an implied performance criterion based on the product claim and mechanism of action for substantial equivalence to predicates.) | The document states: "The AUTOLENS ® System effectively cleans contact lenses automatically without the need for digital rubbing or manual hand cleaning." This claim is supported by the system's mechanism of action (tumbling) and its substantial equivalence to predicate devices that also utilize similar cleaning principles. However, specific quantitative data on the degree of cleaning effectiveness (e.g., removal rates of specific deposits) is not provided in this summary. The primary focus of the effectiveness testing mentioned is on solution stability (pH, temperature, compatibility), rather than a direct measure of cleaning efficacy of the lenses themselves. The clearance relies heavily on the predicate devices' established efficacy for cleaning. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The number of laboratory animals used is not specified, but the tests were "conducted on the plastic components of the system." The data provenance is laboratory testing.
- Effectiveness Testing (Bench Testing for Solution Stability): Three (3) test devices were used to measure solution pH and temperature gain. The data provenance is laboratory bench testing.
- Clinical Information: Clinical studies were deemed "unnecessary" as the multipurpose solution used in the AUTOLENS® System was already cleared for marketing. Therefore, there was no clinical test set for the AUTOLENS® system itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no human experts used to establish a ground truth for the device's performance as described in the summary. The "ground truth" for the device's safety and functionality was established via:
- Laboratory Animal Testing: For biocompatibility.
- Bench Test Measurements: For pH, temperature, and compatibility.
- Predicate Device Equivalence: The primary basis for the cleaning effectiveness claim stems from substantial equivalence to previously cleared devices.
4. Adjudication Method for the Test Set
Not applicable, as no human readers or subjective assessments requiring adjudication were part of the described testing for the device's performance.
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 contact lens cleaning system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical, electromechanical system and does not involve an "algorithm" in the sense of AI. Its performance is inherent to its mechanical action (tumbling) and the chemical properties of the solution. The bench testing performed can be considered "standalone" in that it assessed the device's direct physical and chemical effects.
7. The Type of Ground Truth Used
- Biocompatibility: Established by standardized toxicology tests on laboratory animals.
- Solution Stability (pH, temperature): Established by direct instrumental measurements (pH meter, thermometer) acting as the objective ground truth.
- Compatibility: Visual observation of precipitate formation established the ground truth for compatibility.
- Cleaning Effectiveness: Primarily inferred from the substantial equivalence to predicate devices that perform a similar cleaning function, rather than direct, quantitative ground truth data on cleaning efficacy presented within this summary for the AUTOLENS® system itself. The ground truth for the solution's efficacy (cleaning, rinsing, disinfecting, protein removal) was established through its prior marketing clearance.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”