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510(k) Data Aggregation
(20 days)
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
Focus® DAILIES® and Focus® DAILIES® Toric (neifilcon A) ONE-DAY 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.
Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of 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. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A) ONE-DAY CONTACT LENS are daily wear soft contact lenses intended for single use daily disposable wear. The Dailies lens is a spherical soft contact, Dailies toric lenses have a double thin zone design, and the Dailies Progressives iens is a progressive aspheric simultaneous vision soft contact lens. A constant near power profile is incorporated into each Progressive lens across the full range of distance powers. The near and intermediate powers are concentrated primarily in the central portion of the optical zone while the surrounding portion is weighted toward distance. The continuous changes in power across the surface of the lens allow patients requiring a reading addition of up to +3.00 diopters to see clearly at far, intermediate and near distances.
The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are clear or tinted from edge to edge for visibility purposes with the color additive copper phthalocyanine (CuP).
Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphateacetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108.
The provided document describes the acceptance criteria and the study conducted for the Focus® DAILIES® family of contact lenses (nelfilcon A) to demonstrate substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Focus® DAILIES® lenses were based on demonstrating equivalence to the predicate device (Focus® DAILIES® (nelfilcon A) made without an additive) across key physical/chemical properties and clinical performance. The study aimed to show that lenses made with a manufacturing additive were within established specifications and maintained comparable performance.
| Acceptance Criteria Category | Specific Metric | Predicate Device Performance / Acceptance Limit (if explicitly stated) | Reported Device Performance (with additive) | Outcome |
|---|---|---|---|---|
| Material Properties | FDA Material Classification | FDA Group 2 (> 50% H2O, nonionic polymer) | FDA Group 2 (> 50% H2O, nonionic polymer) | Met |
| Water Content | 69.4% | 68.4% | Met (within equivalent range) | |
| Light Transmittance (clear lenses) | 100% | 100% | Met | |
| Oxygen Permeability (Dk, Coulometric) [35° C, Fatt corrected] | ~25 barrer | 25.86 barrer | Met (within equivalent range) | |
| Design Characteristics | Power Range | +20.00 to -20.00D | +20.00 to -20.00D | Met |
| Visibility Tint | With or without Copper Phthalocyanine | With or without Copper Phthalocyanine | Met | |
| Manufacturing Method | Full Mold Cast, Lightstream Technology | Full Mold Cast, Lightstream Technology | Met | |
| Lens Design | Spherical and/or Multi-focal (No change to established designs) | Spherical and/or Multi-focal | Met | |
| Packaging & Sterilization | Sterilization | Steam sterilization, Validated autoclave | Steam sterilization, Validated autoclave | Met |
| Packaging | Blister Pack | Blister Pack | Met | |
| Package Storage Saline Solution | Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108 | Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108 | Met | |
| Clinical Performance | Overall Performance (vision, health, comfort, fit) | Similar to concurrent predicate control | Demonstrated similar overall performance to concurrent predicate control | Met |
| Biocompatibility | Toxicity & Biocompatibility | Non-toxic and biocompatible with ocular environment | Remain non-toxic and biocompatible with the ocular environment | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the clinical test set. It mentions "A one-month clinical study". The provenance of the data (country of origin) is not specified. The study appears to be prospective as it's a "one-month clinical study" evaluating the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study's evaluation of "vision, health, comfort, and fit." Clinical studies often involve ophthalmologists or optometrists for these assessments, but this is not specified here.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices, rather than contact lenses. The study focused on demonstrating equivalence to an existing device rather than human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a contact lens, not a software algorithm. The "performance" refers to the physical and clinical characteristics of the lens itself.
7. Type of Ground Truth Used
The ground truth for the physical and chemical properties was derived from established specifications and validated measurements against those specifications, comparing the new formulation to the predicate device. For the clinical performance, the ground truth was based on clinical evaluation of vision, health, comfort, and fit which would implicitly involve expert (clinician) assessments, but the exact mechanism for establishing "ground truth" (e.g., expert consensus on what constitutes "similar performance") is not detailed.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set in that context. The "training set" for manufacturing would be the established manufacturing processes and quality controls that lead to the "established specifications" mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI/ML device. For contact lens manufacturing, ground truth (or acceptable quality standards) is established through rigorous engineering specifications, material science, and regulatory requirements, which are then validated through extensive testing (physical, chemical, and clinical).
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