Search Results

DAILIES® Colors (nelfilcon A) One-Day Contact Lenses with refractive power, are indicated for the optical correction of refractive ametropia (myopia, hyperopia ) in not-aphakic persons with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES® Colors Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily disposable 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® Colors Progressives (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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.

DAILIES® Colors (nelfilcon A) One-Day Contact Lenses (with or without corrective power) also act to enhance or alter the apparent color of the eye.

DAILIES® Colors (nelfilcon A) One-Day Contact Lenses are to be prescribed 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.

The subject device, DAILIES Colors contact lenses, are a modification of the currently commercialized FreshLook® One-Day (nelfilcon A) color contact lenses. DAILIES Colors are soft contact lenses intended for the optical correction of refractive error, and the enhancement or alteration of the apparent color of the eye. Geometries include spherical, toric, and multifocal lens designs.

DAILIES Colors lenses are composed of nelfilcon A, which is a non-ionic, hydrophilic lens material, that consists of approximately 69% water and 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are pad printed with intermittent ink layers containing a combination of the following color additives, approved for use in color contact lenses: chromium oxide, iron oxides, [phthalocyaninato (2- )] copper, phthalocyanine green, and titanium dioxide.

Lens designs for DAILIES Colors (nelfilcon A) lenses include spherical, toric, and multifocal lenses in the following parameter range:
• 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 (0.100 mm for -3.00D spherical)

Lenses have the following properties:
• Refractive index: 1.38 (hydrated)
• Water content: 69% by weight in normal saline
• Oxygen permeability 26 barrer units at 35 °C (Fatt corrected)
• % Light transmittance > 88% (average over 380-780 nm)

Lenses are provided in sterile packages of foil-sealed blister-packs containing buffered saline.

The provided text is a 510(k) summary for new contact lenses. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through an independent study with a test set, ground truth, and expert evaluation in the way a diagnostic AI device would.

Therefore, the information required to answer the prompt directly, such as acceptance criteria for performance metrics (e.g., sensitivity, specificity for a diagnostic device), sample sizes for diverse test sets, establishment of ground truth by multiple experts, and comparative effectiveness studies, is not present in this document.

This document states that the scope of the device modification did not necessitate clinical testing and instead relies on non-clinical testing (biocompatibility and process validation) to verify equivalence to the predicate device.

However, I can extract what is provided regarding the "acceptance criteria" and "device performance" within the context of this 510(k) summary:

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion here is substantial equivalence to the predicate device, FreshLook® One-Day (nelfilcon A) color contact lenses (K050213, K180398, K180669). This is demonstrated by showing that the modified device (DAILIES® Colors) has:
  • The same material properties (Nelfilcon A, 69% water content, 26 barrer oxygen permeability, 1.38 refractive index, >88% light transmittance).
  • The same manufacturing method (Lightstream Technology: Full mold cast, integrated print step).
  • The same sterilization method (Steam sterilization).
  • The same packaging (Blister pack) and storage solution.
  • The same intended use and indications for use.
  • Successful biocompatibility testing and process validation (implicitly meeting established safety standards for contact lenses, which are the acceptance criteria for these tests).
  • Clinical performance similar to the predicate device (implied by not requiring new clinical testing due to the nature of the modification).

Since the document explicitly states that clinical testing was not necessitated due to the nature of the modification (an altered print pattern), the concepts of a test set, expert-established ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.

Here's how I can address the prompts based only on the provided text, noting where information is absent:

Acceptance Criteria and Device Performance for DAILIES® Colors Contact Lenses

Given that this 510(k) summary is for a medical device (contact lenses) and not a diagnostic AI/algorithm, the "acceptance criteria" and "device performance" are framed around demonstrating substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of diagnostic performance testing. The "testing" referred to is biocompatibility and manufacturing process validation. Sample sizes for these types of engineering/chemistry tests are typically determined by relevant ISO standards or internal quality protocols, and are not detailed in this summary.
• Data Provenance: Not applicable in the context of diagnostic performance testing. The tests are non-clinical (biocompatibility, process validation) and are implicitly performed by/for the manufacturer (Alcon Laboratories, Inc., Fort Worth, TX).

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)

• Not applicable. This submission does not involve diagnostic ground truth establishment by experts for image interpretation or similar tasks. Biocompatibility testing follows established lab protocols and standards, and process validation is an engineering/manufacturing assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method for a "test set" in the diagnostic sense is mentioned or implied.

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. This is not a study of AI assistance for human readers. The document explicitly states: "The scope of the device modification did not necessitate clinical testing, in order to establish safety or efficacy."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not a submission for an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For this type of device, "ground truth" relates to material specifications (chemical composition, physical properties), manufacturing process parameters, and standard biocompatibility assay results. These are established through validated laboratory tests and engineering specifications, not expert consensus on clinical cases or pathology.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable. (See answer to #8).

Ask a specific question about this device