(182 days)
The Lena Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses,
Lens Comfort is Indicated as aid for cleaning as on accossory for soft hydrophilic lanses and gas permeable lenses when used with the appropriate Barnea-i hind® Soft Mate solutions auch as the Consept Cleaning and Disintection System which is comprised of the Bernes-Hinde Soft Mare Consept . 1 Cleaning and Disinfecting solution and Barnes-Hinde Soft Mate® Consepte-2 Neutralizing and Pinaing Solution or Spray. The Lans Comfort Contact Lons Care Accessory Is indicalad for use for gas permeable solutions auch as Barnes. Hind® Gas Permeable Daily Cleaner and Barnes-Hind® ComfortCare GP Welting and Solution. The Lens Comfort Contact Lons Care Accessory may be used for a receptacie for chamical disinfection.
The Lens Comfort Ultrasonic Contact Lens Care Accessory uses a plezo-electric crystal to generate a wave form. In a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of tomperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The Lans Comfort device uses standerd power (110 v/120 v). There is a four (4) foul cord and a UL approved wall transformer.
The Lens Comfort device consists of the housing, lens beskets, a reasivoir, electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally merkated predicate devices in the United States. The housing is injection molded of polycarbonate. The baskets and supporting structure are injection molded from polyethylene. The reservoir is deep drawn stallnioss steel, is passivated and pollshed. The electronic circultry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.
Here's an analysis of the provided 510(k) summary regarding the Lens Comfort Ultrasonic Contact Lens Care Accessory, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No changes in lens physical and optical parameters after cleaning: Color, Clarity, Power, Diameter, Base Curve. | "No changes were noted in color, clarity, power, diameter or base curve." |
| No deposits or residue on lenses after cleaning. | "The lenses all appeared clear and no deposits or residue or damage were noted on any of the lenses." |
| No damage to lenses after cleaning. | "The lenses all appeared clear and no deposits or residue or damage were noted on any of the lenses." |
| Compatibility with specified contact lens solutions. | "Lens Comfort references the same solutions [Sole/Barnes-Hind® Solutions] and data." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the number or type (e.g., brand, material) of unique lenses used in the test set. It mentions "Lenses were selected from Group 1, Group 3, Group 4 and the Gas Permeable class." It also states, "Thirty (30) cycles were performed on all lenses." This suggests a protocol that subjects each tested lens to 30 cleaning cycles.
The data provenance is not explicitly stated in terms of country of origin. The study was "conducted by an optometrist who is director of optometric services in a large ophthalmology practice," implying a clinical setting, but whether this was in the US or elsewhere is not specified. The study appears to be prospective as it involves the active testing of the device according to a protocol.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by one expert: "an optometrist who is director of optometric services in a large ophthalmology practice." Their qualifications as an optometrist and director of optometric services suggest expertise in evaluating contact lens health and performance. No further details on years of experience or board certifications are provided.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method. The evaluation appears to have been performed by a single optometrist, who assessed the lenses for changes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses solely on the performance of the Lens Comfort device against established cleaning standards, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical accessory for cleaning contact lenses, not an algorithm or AI system. The "standalone" performance here refers to the device's ability to clean lenses without human intervention in the cleaning process, which it is designed to do. Human evaluation is required for the assessment of the cleaning outcome.
7. The Type of Ground Truth Used
The ground truth used was expert assessment/observation by an optometrist. This involved the direct measurement and visual inspection of physical and optical parameters of the contact lenses.
8. The Sample Size for the Training Set
This question is not applicable. The Lens Comfort device is a physical product, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
§ 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.”