(195 days)
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 (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.
Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear 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 (myopia or hyperopia) 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.
All DAILIES® (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.
Focus® DAILIES® family and DAILIES® AquaComfort Plus® family are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs.
The DAILIES® 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 contact lens material per 1994 FDA 510(k) guidance document for daily wear contact lenses. The lens material further contains non-functionalized PVA (high- and/or 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® 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 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 package saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES® AquaComfort Plus® family lenses 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.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate Devices) | Reported Device Performance (Modified Devices) |
|---|---|
| Technology Information | |
| Lens Material: nelfilcon A | Same |
| Material Classification: FDA Group 2 (>50% H2O, nonionic) | Same |
| Water Content: 69% | Same |
| Visibility Tint: Light blue | Same |
| Manufacturing Method: Lightstream Technology: Full mold cast | Same |
| Lens Designs: Spherical, toric, multifocal | Same |
| Sterilization: Steam sterilization, validated autoclave | Same |
| Primary Packaging System: Foil blister pack | Same |
| Primary Packaging Blister Shell: Injection-molded polypropylene from Flint Hills Resources P4C5N-046 | Injection-molded polypropylene from Flint Hills Resources P4C5N-046 or Formosa 4142T |
| Primary Packaging Foil Lidding: Multi-layer laminate structure polyester-coated aluminum foil lidding from Constantia-Hueck Folien or Huhtamaki | Multi-layer laminate structure polyester-coated aluminum foil lidding from Constantia-Hueck Folien or Huhtamaki |
| Package Storage / Saline Solution: Phosphate-acetate buffered saline with up to 0.05% Poloxamer 108. Additionally contains PEG and HPMC (for DAILIES AquaComfort Plus family) | Same |
| Performance Specifications | |
| Refractive Index: 1.38 | Same |
| Light Transmittance: ≥ 92%T | Same |
| Oxygen Permeability (Dk): 26 | Same |
| Elastic Modulus: 0.9 MPa | Same |
| Biocompatibility: Biocompatible | Biocompatible (confirmed by testing) |
| Shelf-life: 60 months | 60 months (confirmed by stability testing) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size for the modified devices as part of a standalone study directly assessing their primary performance against acceptance criteria in a quantitative manner. Instead, the focus is on a comparison to predicate devices and confirmation of performance through various non-clinical tests.
- Biocompatibility Testing: Conducted on a "series of in vivo biocompatibility evaluations." The specific number of samples or animals used is not detailed, but it was conducted in accordance with GLP regulation (21 CFR Part 58) and relevant ISO 10993 series standards. This implies a standard, but unspecified, number of samples for such tests.
- Stability Testing: Conducted to support the labeled expiration date. The sample size is not specified.
- Clinical Testing: Not required due to the "great similarity of the modified devices to the predicate devices and successful results from nonclinical testing." This means no human clinical test set was used for the modified devices to establish substantial equivalence directly, in terms of primary clinical performance.
Data Provenance: The document implies that the biocompatibility and stability testing data was generated by the manufacturer (Alcon Laboratories, Inc.). There is no mention of country of origin for the data or if it was retrospective or prospective, though in vivo studies are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. No ground truth in the sense of expert consensus on image interpretation or diagnostic performance was established for a test set, as clinical testing was not deemed necessary for the modified devices. The "ground truth" for the non-clinical tests would be the established scientific and regulatory standards for biocompatibility and stability, as interpreted by the testing labs and regulatory agencies.
4. Adjudication Method:
Not applicable. No adjudication method was mentioned for a clinical test set, as clinical testing was not performed for the modified devices to establish substantial equivalence. For non-clinical tests, reconciliation of results would follow standard laboratory practices and regulatory guidelines, rather than an adjudication method among experts for a diagnostic outcome.
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 performed. Clinical testing was explicitly stated as "not required" due to the similarity to predicate devices and successful non-clinical testing. Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a contact lens, not a medical imaging or diagnostic algorithm. Thus, the concept of "standalone" algorithm performance without human-in-the-loop is not relevant. The device itself is the primary product, and "performance" refers to its physical and biological properties.
7. The Type of Ground Truth Used:
The "ground truth" for the assessment of this device is based on:
- Established device specifications and performance characteristics of the predicate devices (e.g., refractive index, light transmittance, oxygen permeability, elastic modulus, water content). The modified devices were compared to these established values.
- Biocompatibility standards: ISO 10993 series and GLP regulations. The "truth" is whether the materials and final product meet these safety standards (e.g., non-cytotoxic, non-irritating).
- Stability standards: The ability to maintain specified performance characteristics over the labeled shelf-life.
This ground truth is primarily based on measured physical and chemical properties, and established regulatory safety standards, rather than expert consensus on a diagnostic outcome or pathology.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device (contact lens), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is established, and design parameters are derived from engineering and material science, not data-driven training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for an AI/ML algorithm.
§ 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.