Search Results

Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism.

Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Dailies Total1 (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 that does not interfere with visual acuity.

Dailies Total1 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 Total1 for Astigmatism (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.

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.

Dailies Total1 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.

Precision1 (P1) (verofilcon A lens material) and Dailies Total1 (DT1) (delefilcon A) are soft contact lenses, intended for on-eye use in persons with healthy eyes that need vision correction as determined and fitted by an eye care professional. The lensed for single use, daily disposable wear (less than 24 hours while awake) only.

Precision1 (verofilcon A) and Dailies Total1 (delefilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foil-blister packs, which are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packs are packaged into carton boxes available in different pack sizes.

Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric (for astigmatism) lens design.

Dailies Total 1 (delefilcon A) soft contact lenses are available in spherical, toric (for astigmatism) and multifocal toric lens designs.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for Alcon's contact lenses (Precision1 and Dailies Total1 families). It primarily discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• The general controls and regulations applicable to the devices.
• The indications for use for the various contact lens products.
• A summary of the device description and intended use.
• A statement that the submission is for a manufacturing change (modification of extraction and coating processes) and that no clinical testing was required to establish safety and effectiveness for this specific change. Instead, non-clinical bench testing demonstrated that the lenses meet established finished product specifications and are substantially equivalent to the predicate devices.

Therefore, I cannot fulfill your request as there is no information in the provided text regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

These elements are typically found in documents describing clinical trials, performance studies for AI/ML-driven devices, or detailed design verification and validation reports, none of which are present in this FDA 510(k) clearance letter.

Ask a specific question about this device