(155 days)
DAILIES TOTAL 1® (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.
DAILIES TOTAL 1® (delefilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less 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 or aphakic 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.
DAILIES TOTAL 1® (delefilcon A) multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of astigmatism and who may require a reading addition of +3.00 diopters (D) or less.
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.
The lens material is 33% water and 67% delefilcon A, a silicone containing hydrogel with added phosphatidylcholine. The core lens material containing 33% water transitions through a water gradient to a hydrogel surface layer that exceeds 80% water. Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.
Delefilcon A lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges:
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm
Power Range: -20.00D to +20.00D
Center Thickness: varies with design and power (0.09 mm for -3.00D spherical)
Lenses have the following properties:
Refractive index: 1.42 (hydrated)
Light transmittance: ≥ 93% (@610 nm, -1.00D)
Water content: 33% by weight in normal saline
Surface water content: ≥ 80%
Oxygen permeability: 140 x 10-11 [(cm2 /sec)(ml O2 /ml.mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)
Each lens is packaged in a foil-sealed plastic containing phosphate buffered saline solution with approximately 0.3% of polymeric wetting agents consisting of copolymers of polyamidoamine and poly(acrylamide-acrylic acid) and are steam sterilized.
Here's an analysis of the provided text regarding the Delefilcon A Soft Contact Lenses (DAILIES TOTAL1®) K113168 submission, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for contact lenses primarily focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific numerical performance acceptance criteria in the same way a diagnostic algorithm might. The core "acceptance criteria" here are defined by the predicate device's properties and established safety/efficacy.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Delefilcon A) | Comparison/Outcome |
|---|---|---|---|
| Non-clinical Properties | (Implicit: Similar to or better than predicate, non-toxic, biocompatible, optically/dimensionally/physico-chemically comparable) | ||
| Intended Use | Daily Disposable Wear | Daily Disposable Wear | Equivalent |
| Mode of Action | Refracting medium to focus light rays on the retina | Refracting medium to focus light rays on the retina | Equivalent |
| Lens Material Group | ISO Group V (silicone hydrogel) | ISO Group V (silicone hydrogel) | Equivalent |
| Manufacturing Method | Molded | LightStream | Different method, but efficacy & safety demonstrated. |
| Sterilization Method | Moist Heat | Moist Heat | Equivalent |
| Packaging | Blister Pack | Blister Pack | Equivalent |
| Handling Tint | Lt. Blue | Lt. Blue | Equivalent |
| Refractive Index | 1.41 | 1.42 | Similar (minor difference) |
| Water Content (%) | 48% | 33% (core), ≥ 80% (surface) | Different, but considered acceptable due to water gradient design. |
| Oxygen Permeability | 55 (hydrated Dk) | 140 (intrinsic Dk-Coulometric method) | Significantly higher (better). |
| BC/Diameter (mm) | 8.5/14.2 | 8.5/14.1 | Similar (minor difference) |
| Power (D) | various | various | Equivalent |
| Biocompatibility | Non-toxic, non-irritating (implied) | Non-toxic, non-irritating | Meets (explicitly stated) |
| Optical/Dimensional/Physico-chemical Properties | Consistent with marketed lenses (implied) | Consistent with or better than predicate lenses tested | Meets (explicitly stated) |
| Compatibility with Rewetting Drops/Saline | (Implicit: Compatible) | Compatible with commonly available contact lens rewetting drops and saline solutions | Meets (explicitly stated) |
| Clinical Performance | (Implicit: Similar safety and efficacy to predicate lens) | ||
| Primary Safety Variable | Biomicroscopy findings (similar to predicate) | Similar performance between test and control lenses | Meets (explicitly stated) |
| Primary Efficacy Variable | Visual acuity (similar to predicate) | Similar performance between test and control lenses | Meets (explicitly stated) |
| Other Variables | Refraction, keratometry, subjective ratings (vision, comfort, handling) (similar to predicate) | Similar performance between test and control lenses | Meets (explicitly stated) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Study: 60 subjects for the Delefilcon A (test) lenses and 30 subjects for the Narafilcon B (control) lenses. (Total: 90 subjects)
- Non-clinical Testing: The text does not specify sample sizes for non-clinical tests (e.g., in vitro material testing, biocompatibility).
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was conducted retrospectively or prospectively. However, the description "a three-month clinical study was conducted" and "prospective, randomized, parallel group design" strongly indicates a prospective study. The submitter, CIBA VISION Corporation, is based in Duluth, Georgia, USA, suggesting the study likely took place in the US or under US regulatory oversight.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to a contact lens submission, as "ground truth" in the context of diagnostic AI/ML is typically established by expert consensus on image interpretation or pathology.
For contact lenses, the "ground truth" for efficacy and safety variables like visual acuity, biomicroscopy findings, and subjective ratings (comfort, vision, handling) is established through standardized clinical examination procedures performed by qualified investigators and ophthalmologists/optometrists who conduct the clinical trial. Their qualifications are assumed to be appropriate for conducting clinical trials involving contact lenses. The number of such experts involved is not specified but would include the clinical investigators and potentially a data safety monitoring board.
4. Adjudication Method (for the test set)
The document mentions "biomicroscopy findings" as a primary safety variable and "visual acuity" as a primary efficacy variable. For these objective measurements, adjudication in the sense of expert consensus on ambiguous cases (as in image interpretation) is generally not performed. Measurements are typically taken by trained clinical personnel. Subjective ratings (vision, comfort, handling) are self-reported by the subjects. There is no indication of an adjudication method described for the clinical trial data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a soft contact lens, not an AI/ML-driven diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not performed. The clinical study performed was a direct comparison of the new lens to a predicate lens.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (contact lens), not an algorithm. So a standalone algorithm performance study was not done.
7. The Type of Ground Truth Used
For the clinical study:
- Safety: Established through biomicroscopy findings (objective clinical assessment of eye health by investigators) and observation of adverse events.
- Efficacy: Established through visual acuity measurements (objective assessment) and refraction/keratometry (objective measurements).
- Patient Experience: Established through subjective ratings of vision, comfort, and handling (patient-reported outcomes).
For the non-clinical testing:
- Material Properties: Established through standardized laboratory testing (e.g., refractive index measurements, water content testing, oxygen permeability Dk measurement).
- Biocompatibility: Established through GLP-compliant (21 CFR Part 58) non-clinical biocompatibility testing as per established industry standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device (contact lens), not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a contact lens device.
§ 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.