Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or 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. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily 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 AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia 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.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact 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.

Device Description

Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The Focus DAILIES and DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.

The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high molecular weight PVA (for Focus DAILIES lenses) and/or ultra-high molecular weight PVA (for Dailies AquaComfort Plus lenses) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.

Focus DAILIES and DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foilblister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).

The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.

The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (DAILIES AquaComfort Plus products) and/or 0.85 ml (Focus DAILIES products) phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. For DAILIES AquaComfort Plus lenses the package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.

AI/ML Overview

The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered medical device.

Instead, it is a 510(k) summary for contact lenses (Focus DAILIES and DAILIES AquaComfort Plus) which outlines a modification to an alternate foil lidding material for their primary packaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for traditional medical devices under the 510(k) pathway, not AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details relevant to an AI/ML device from this document.

Here's why and what information is missing:

No AI/ML Component: The device described is a soft contact lens, a physical medical device. There is no mention of any AI or machine learning component, software, or algorithm in its functionality or development.
No Performance Metrics for AI: Consequently, there are no AI/ML-specific performance metrics like sensitivity, specificity, AUC, F1-score, etc., nor any acceptance criteria for these.
No Study Design for AI Validation: The "Performance Data" section discusses:
- Non-clinical Testing: Stability, biocompatibility, and process validation, referencing ISO standards relevant to material safety and manufacturing for contact lenses. These are not AI/ML validation studies.
- Clinical Testing: States that clinical testing was not required for this specific modification (changing packaging material), which further confirms the absence of AI/ML validation studies.
No Mention of Ground Truth, Training Data, Experts: Since there's no AI, there's no need for ground truth establishment, training data, or expert adjudication as would be required for an AI/ML device.
No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.

In summary, the provided document is not about an AI/ML medical device and therefore does not contain the information you requested.

Summary

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August 21, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alcon Laboratories, Inc. % Andreas Friese Regulatory Project Director Alcon / CIBA Vision GmbH Industriering 1 Grosswallstadt, Bavaria 63868 Germany

Re: K202036

Trade/Device Name: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives. DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: MVN, LPL Dated: July 16, 2020 Received: July 23, 2020

Dear Mr. Friese:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Angelo Green. PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202036

Device Name

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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8 510(k) Summary

This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.

Submitter Information I.

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Contact Person:	Dr. Andreas Friese, Regulatory Project Director
Phone:	+49 6022-240-514
Fax:	+49 6022-240-512
Email:	andreas.friese@alcon.com
Date Prepared:	July 16, 2020

Devices Subject to this 510(k) II.

Trade Names:	Focus DAILIES,Focus DAILIES Toric,Focus DAILIES ProgressivesDAILIES AquaComfort Plus,DAILIES AquaComfort Plus FreshTech,DAILIES AquaComfort Plus Toric,DAILIES AquaComfort Plus Multifocal
Common Name:	Soft Contact Lenses
Classification Name:	Soft (Hydrophilic) Contact Lenses
Device Classification:	Class II [21 CFR 886.5925]
Product Code:	LPL, MVN

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III. Predicate Device

The 510(k) devices are a modification of the same predicate devices, i.e. Focus DAILIES and DAILIES AquaComfort Plus family (nelfilcon A) soft contact lenses, which are legally commercialized devices in the US per the following most recent US FDA 510(k) clearances: K180669 and K181454.

IV. Device Description

Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.

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Indications for Use v.

The 510(k) devices are a modification of the same predicate devices. The Indications for Use remain the same:

Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or 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. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with nondiseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia 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.

VI. Comparison of Technological Characteristics with the Predicate Device

The proposed device modification involves adding an alternate foil lidding material for use in the primary packaging of Focus DAILIES and DAILIES AquaComfort Plus soft contact lenses.

The following matrix (Table 1) summarizes the characteristics of the modified devices as compared to the predicate devices.

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Element ofComparison	Predicate Device(s)	Modified Device(s)
Administrative / Regulatory Information
510(k) Number	K180669 and K181454	To be assigned
Product Name(s)	Focus DAILIES, FocusDAILIES Toric, FocusDAILIES Progressives,DAILIES AquaComfort Plus,DAILIES AquaComfort PlusFreshTech, DAILIESAquaComfort Plus Toric,DAILIES AquaComfort PlusMultifocal	Same
DeviceClassificationInformation	Class II, Soft (Hydrophilic)Contact Lenses, 21 CFR886.5925	Same
Indications For Use Information
Intended Use	One-day contact lenses for theoptical correction of refractiveerror. Single use, dailydisposable wear.	Same
Technology Information
Lens Material	nelfilcon A	Same
MaterialClassification	FDA Group II (>50% H2O,nonionic)	Same
Water Content	69%	Same
Visibility Tint	Light blue	Same
ManufacturingMethod	Lightstream Technology:Full mold cast	Same
Lens Designs	Spherical, aspherical, toric,multifocal	Same
Sterilization	Steam sterilization, validatedautoclave	Same
PrimaryPackaging System	Foil blister pack:polypropylene blister shellsealed with a polyester coatedaluminum foil lidding	Same
Element ofComparison	Predicate Device(s)	Modified Device(s)
PrimaryPackaging BlisterShell	Injection-molded poly-propylene (PP) blister shell	Same
PrimaryPackaging FoilLidding	Multi-layer laminate structurepolyester-coated aluminumfoil lidding supplied by:• Constantia-Pirk Folien• Huhtamaki	Multi-layer laminate structurepolyester-coated aluminumfoil lidding supplied by:• Constantia-Pirk Folien• Huhtamaki• Containers Printers
Package Storage /Saline Solution	Phosphate-acetate bufferedsaline (with PEG and HPMCadditives for DAILIESAquaComfort Plus products)and up to 0.05% Poloxamer108	Same
Performance Specifications including any Testing
Refractive Index	1.38	Same
LightTransmittance	≥ 92%T	Same
OxygenPermeability (Dk)	26	Same
Elastic Modulus	0.9 MPa	Same
Biocompatibility	Biocompatible as confirmedby biocompatibility testing	Same
Shelf-life	60 months as confirmed byshelf-life stability testing	Same

Table 1: Substantial Equivalence Comparison

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Table 1: Substantial Equivalence Comparison

In accordance with the criteria for claims of substantial equivalence in the FDA guidance Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the information provided supports the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process.

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VII. Performance Data

Performance testing was conducted in consideration of the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses. The following performance data are provided in support of the substantial equivalence determination:

Non-clinical Testing

Successful stability and biocompatibility testing as well as process validation were completed for the modified device to verify equivalence to the predicate device. This resulted in all acceptance criteria being met. The non-clinical testing was conducted as described in the following standards.

StandardIdentifier	Standard Title	Version	FDARecognitionNumber
ISO 10993-1	Biological Evaluation of Medical Devices - Part1: Evaluation and Testing within a RiskManagement Process	2018	2-258
ISO 10993-5	Biological Evaluation Of Medical Devices -Part 5: Tests For In Vitro Cytotoxicity	2009	2-245
ISO 10993-10	Biological Evaluation Of Medical Devices -Part 10: Tests For Irritation And SkinSensitization	2010	2-174
ISO 10993-11	Biological Evaluation Of Medical Devices -Part 11: Tests For Systemic Toxicity	2017	2-255

Clinical Testing

The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device.

Regulation Number and Section

§ 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.