(58 days)
DAILIES TOTAL 1® (delefilcon A) 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 that does not interfere with visual acuity.
DAILIES TOTAL1® Toric (delefilcon A) 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 6.00 diopters (D) of astigmatism.
DAILIES TOTAL 1® Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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 (D) of astigmatism that does not interfere with visual acuity.
DAILIES TOTAL 1® Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) 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 6.00 diopters (D) of astigmatism.
The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES TOTAL 1® (delefilcon A) soft contact lenses may be made available in sphere, toric, multifocal, and multifocal toric lens designs.
The lens material, delefilcon A, is a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment.
When hydrated and placed on the cornea, DALIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.
It is considered a Group 5C material according to ISO 18369-1:2017. The lenses have a light blue tint that makes to see when handling.
The modified lenses are tinted using Reactive Blue 247.
The lenses are cast-molded and have a water gradient surface treatment. Lenses may be made available in the following parameter range:
- Diameter: 13.0 to 15.0 mm
- Base Curve: 8.0 to 9.2 mm
- Power Range: +20.0 D to -20.0 D
- Center Thickness: 0.070 mm to 0.340 mm (varies with power)
- Cylinder Power: Up to 5.00 D
- Cylinder Axis: 1° to 180°
- ADD power: Up to 5.00 D
Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution with polymeric wetting agents that form the water gradient surface.
This document is a 510(k) Premarket Notification from the FDA regarding Alcon Laboratories' DAILIES TOTAL1® contact lenses. It addresses the substantial equivalence of modifications to the existing device.
Here's an analysis to extract the requested information regarding acceptance criteria and the study proving the device meets them:
Important Note: This FDA document approves modifications to an existing contact lens. Therefore, the "acceptance criteria" and "study" described here are primarily focused on demonstrating that the modified device remains substantially equivalent to the predicate device, rather than proving a new device's initial safety and effectiveness from scratch. This distinction is crucial for interpreting the provided information.
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are not presented in a formal table with specific numerical targets. Instead, the document states that the performance testing aimed to demonstrate "substantial equivalence" to the predicate device. The reported device performance is described qualitatively as "demonstrated to be substantially equivalent" and "all with passing results."
Here's a breakdown of the areas tested and the general "performance":
| Acceptance Area | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Lens Material Properties | Substantially equivalent to predicate device (e.g., Refractive Index, Light Transmittance, Oxygen Permeability, Water Content). | "The predicate and subject DAILIES TOTAL 1® (delefilcon A) soft contact lenses have the same lens material properties: |
- Refractive Index (hydrated): 1.42
- Light Transmittance: ≥ 93% (@ 610 nm, -1.00 D)
- Oxygen Permeability: 140 barrer
- Water Content: 33% by weight in normal saline" |
| Dimensional & Optical Properties | Substantially equivalent to predicate device (maintaining appropriate ranges for diameter, base curve, power, center thickness, cylinder, ADD). | "Lens material properties, dimensional and optical properties, and extractables and residuals were demonstrated to be substantially equivalent to the predicate device."
The document also lists the available parameter ranges: - Diameter: 13.0 to 15.0 mm
- Base Curve: 8.0 to 9.2 mm
- Power Range: +20.0 D to -20.0 D
- Center Thickness: 0.070 mm to 0.340 mm (varies with power)
- Cylinder Power: Up to 5.00 D
- Cylinder Axis: 1° to 180°
- ADD power: Up to 5.00 D |
| Extractables & Residuals | Levels should be safe and substantially equivalent to the predicate. | "Lens material properties, dimensional and optical properties, and extractables and residuals were demonstrated to be substantially equivalent to the predicate device." |
| Shelf-Life Stability | Packaged lenses must remain sterile and stable for the labeled expiration date. | "Results of an ongoing shelf-life stability study demonstrate that packaged lenses remain sterile and stable for the labeled expiration date." |
| Biocompatibility | Must pass all relevant ISO 10993 series tests and GLP requirements, showing no unacceptable biological risk. | "Nonclinical biocompatibility testing was conducted... and relevant parts of the ISO 10993 series. Specifically, the following testing was completed, all with passing results: - Cytotoxicity Studies (lens, lens extracts, and package saline) per ISO 10993-5
- Ocular Irritation / Toxicity (Ocular) in Rabbits
- Ocular biocompatibility of soft contact lenses, 22-day Evaluation per ISO 9394
- Ocular biocompatibility of package saline, 22-Day Evaluation per ISO 9394
- Primary ocular irritation studies per ISO 19993-10 (lens extracts and package saline)
- Sensitization Studies (lens extracts and package saline) per ISO 10993-10
- Acute Systemic Toxicity Study in Mice (lens extracts) per ISO 10993-11
- Genotoxicity Studies (lens extracts and package saline) per ISO 10993-12"
Additional testing for packaging foil: "Cytotoxicity Studies (foil lidding, foil lidding extracts) per ISO 10993-5", "Ocular Irritation / Toxicity (Ocular) in Rabbits", "Primary ocular irritation studies per ISO 19993-10 (foil lidding extracts)." All "passing results". |
| Sterilization (Moist Heat) | Must effectively sterilize the lenses and maintain sterility in packaging. | "Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs..." (Implied successful sterilization method). |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state numerical sample sizes for any of the non-clinical tests (e.g., number of lenses tested for material properties, number of animals in biocompatibility studies). It only mentions that testing was conducted "using GxP conditions," referring to good x practice (e.g., Good Manufacturing Practices, Good Laboratory Practices).
The data provenance (country of origin, retrospective/prospective) is also not specified. Given the regulatory nature and the mention of GLP for biocompatibility, these studies would have been prospective and conducted according to relevant international standards.
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 or not provided in this document.
- No expert ground truth for classification/diagnosis: The testing described is primarily physical, chemical, and biological (biocompatibility) in nature for a medical device (contact lens). There is no "ground truth" in the sense of expert human interpretation of medical images or patient conditions, as would be the case for an AI diagnostic device.
- Standards-based evaluation: The "ground truth" for these tests comes from established industry standards (e.g., ISO for contact lenses, ISO 10993 for biocompatibility) and regulatory guidelines (e.g., FDA 510(k) Guidance for Class II Contact Lenses). The "experts" involved would be the testing laboratories' personnel with expertise in these specific tests and their interpretation according to the standards. Their specific qualifications and numbers are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or human-in-the-loop performance evaluations for diagnostic devices where human experts disagree on interpretations. Here, the testing is non-clinical/laboratory-based against pre-defined physical, chemical, and biological criteria and established standards.
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
This information is not applicable. This document is for a contact lens, not an AI diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document is for a contact lens; there is no algorithm or AI involved. The "device performance" refers to the physical, chemical, and biological properties of the contact lens itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing of this contact lens is based on:
- Established industry standards: Primarily ISO 18369-2, -3, -4 for contact lenses and ISO 10993 series for biocompatibility.
- FDA guidance documents: Specifically the May 1994 FDA guideline titled "Premarket Notification 510(k) Guidance Document for Class II Contact Lens testing."
- Prior device specifications: The modified device is compared to the predicate device to demonstrate substantial equivalence across various properties.
- GLP (Good Laboratory Practices) requirements: For biocompatibility testing (21 CFR Part 58).
So, the ground truth is standards-based and regulatory-guidance driven, ensuring the device meets pre-defined safety and performance thresholds for physical, chemical, and biological attributes, and remains equivalent to a previously cleared device.
8. The sample size for the training set
This information is not applicable. This is a physical medical device (contact lens), not a machine learning/AI model. Therefore, there is no "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 this type of 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.