(56 days)
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who 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.
The 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 (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 (myperopia) 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.
FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The 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 TOTAL (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism.
DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism .
The 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.
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable. The lens material of Focus DAILIES, DAILIES AquaComfort Plus, and FreshLook One-Day products is nelfilcon A. DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. The lenses are supplied sterile in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave.
This document is a 510(k) premarket notification for several types of soft contact lenses manufactured by Alcon Laboratories, Inc. The purpose of this submission is to demonstrate that the modified devices are substantially equivalent to their legally marketed predicate devices.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics in the way one might expect for a new device claiming improved performance. Instead, it focuses on demonstrating that the modified devices maintain the same performance specifications as their predicate devices. The acceptance criterion implicitly seems to be "no negative impact on safety, efficacy, and performance compared to predicate devices, and consistency with established standards."
The "Performance Data" section lists the types of testing conducted to support substantial equivalence, rather than specific numerical acceptance criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and biocompatible | "Test results from a series of in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing, confirm that the minor device modification does not negatively impact the safety of the devices and that the modified devices are non-toxic and biocompatible." (All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.) |
| Stability: Support labeled expiration date | "Successful stability testing supports the labeled expiration date for the modified devices." |
| Clinical Performance: No negative impact on clinical outcomes (implicit) | "Based on the great similarity of the modified devices to the predicate devices and successful results from nonclinical testing, clinical testing was not required to establish substantial equivalence." (Therefore, no specific clinical performance metrics are reported for the modified devices beyond the established performance of the predicate lenses.) |
| Technological Characteristics: Maintain key specifications of predicate devices | The "Comparison of Technological Characteristics with the Predicate Device" (Table 1, pages 10-13) explicitly states "Same" for all listed technological characteristics including: Device ClassificationIntended UseLens Material (nelfilcon A, delefilcon A)Water Content (69%, 33%)Visibility TintManufacturing MethodLens Designs (Spherical, toric, multifocal)SterilizationPrimary Packaging SystemPrimary Packaging Blister ShellPackage Storage / Saline SolutionRefractive IndexLight TransmittanceOxygen Permeability (Dk)Elastic Modulus (MPa)Shelf-life |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Biocompatibility Testing: The document states "Test results from a series of in vivo biocompatibility evaluations" but does not specify the sample size for these tests. It indicates the tests were "conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards." Provenance information (country, retrospective/prospective) is not provided.
- Stability Testing: "Successful stability testing supports the labeled expiration date." No specific sample size, provenance, or detailed methodology is provided.
- Clinical Testing: No clinical testing was performed for the modified devices to establish substantial equivalence. Therefore, there is no sample set, provenance, or type of study to report for clinical trials. The assumption is that the clinical performance of the predicate devices is maintained due to the minor nature of the modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes a 510(k) submission for contact lenses, which does not involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI/CAD device would. The "ground truth" for contact lenses is established through well-defined physical, chemical, and biological testing methods against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are used in studies where human experts are tasked with independently assessing cases, and discrepancies need to be resolved. The testing described here (biocompatibility, stability, material characteristics) does not involve such human-expert adjudication processes.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for AI/CAD systems that assist human readers in tasks like image interpretation, which is not relevant to soft contact lenses.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device in question is a physical medical device (contact lens), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific tests mentioned:
- Biocompatibility: The "ground truth" is established by the results of standardized in vivo (e.g., animal models) and in vitro (e.g., cell cultures) tests based on ISO 10993 standards and measured against predefined toxicity and irritation thresholds.
- Stability: The "ground truth" is established by direct measurement of physical and chemical properties of the lenses over time under various conditions to ensure they meet specifications throughout their shelf-life.
- Technological Characteristics: The "ground truth" is established by direct measurement of physical properties (e.g., refractive index, water content, oxygen permeability, elastic modulus) using validated scientific methods, compared against the known values of the predicate devices and product specifications.
8. The sample size for the training set
This information is not applicable. The submission is for a physical medical device (contact lenses), not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a contact lens product.
§ 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.