(27 days)
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.
The DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.
The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high and ultra-high molecular weight PVA and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.
DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.
The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
This document describes the 510(k) submission for Alcon Laboratories, Inc.'s DAILIES AquaComfort Plus contact lenses, focusing on an extension of their expiration dating. As such, the study described is primarily related to shelf-life stability and not clinical performance or artificial intelligence (AI) device performance. Therefore, many of the requested categories are not applicable (N/A) or cannot be extracted from this document, as it does not describe a clinical performance study with human readers or an AI algorithm.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|---|
| Shelf-life | 60 months | 84 months (confirmed by shelf-life stability testing) |
| Biocompatibility | Biocompatible (as confirmed by biocompatibility testing) | Biocompatible (cytotoxicity testing by Cell Growth Inhibition (CGI) and Modified ISO/USP Elution (MEL) methods completed, all acceptance criteria met to verify equivalence to predicate device) |
| Refractive Index | 1.38 | Same |
| Light Transmittance | $\ge$ 92%T | Same |
| Oxygen Permeability (Dk) | 26 | Same |
| Elastic Modulus | 0.9 MPa | Same |
| (Other material properties, manufacturing method, packaging, etc.) | Same as predicate | Same |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a distinct "test set" in the context of an AI algorithm or traditional clinical trial. The testing performed was primarily non-clinical stability testing.
- Sample Size: Not explicitly stated for stability testing within this document. Stability studies involve testing multiple samples over time.
- Data Provenance: The document implies in-house testing by Alcon Laboratories, Inc., as part of the manufacturing and regulatory compliance process. The country of origin of the data is not specified beyond Alcon's location (Fort Worth, TX for the company, and the contact person in Germany). The data is retrospective in the sense that it's gathered over time as part of a stability study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
N/A. This submission focuses on shelf-life and biocompatibility, not clinical expert-based ground truth for device performance in diagnosis or image interpretation.
4. Adjudication Method for the Test Set
N/A. Adjudication methods are typically employed in clinical studies or for ground truth establishment for AI where multiple experts might disagree. This is not relevant to the non-clinical stability testing described.
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
N/A. This device is a contact lens, and the submission is for an extended shelf-life. There is no AI component or human reader comparative effectiveness study involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This is not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Shelf-life: The "ground truth" is derived from established laboratory testing protocols and standards for contact lens stability (e.g., measuring physical and chemical properties over time).
- Biocompatibility: The "ground truth" is based on recognized in vitro cytotoxicity testing methods (Cell Growth Inhibition and Modified ISO/USP Elution methods) and their pre-defined acceptance criteria for biocompatibility, often benchmarked against predicate devices or regulatory standards.
8. The Sample Size for the Training Set
N/A. There is no AI model or training set described.
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable as there is no AI model or training set.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.