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

Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D) or less of astigmatism.

Lotrafilcon B multifocal soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic 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.

Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia in phakic persons with non-diseased eves and up to 6.00 diopters (D) or less of refractive and/or corneal astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear (lenses are discarded upon removal from the eye) or daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion and frequent replacement, as recommended by the eye care professional.

Device Description

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Contact lenses contain the color additive phthalocyanine blue, a light blue handling tint, which helps make them easier to see when handling.

Lotrafilcon B lens designs include spherical. toric, multifocal toric 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 (Example: 0.08 mm for -3.00D spherical)

Lenses have the following properties:

. Refractive index: 1.42 (hydrated)
Light transmittance: > 94 % ●
Water content : 33% by weight in normal saline
Oxygen permeability 110 x 10-11 ●
[(cm2 /sec)(ml O2 /ml mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)

Lotrafilcon B contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with or without additives [1% Copolymer 845, or 1% Copolymer 845 and 0.04% (400 ppm) polyoxyethylene-polyoxybutylene copolymer (EO45BO10)]. The compatibility and package integrity of the blister pack packaging system have been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).

AI/ML Overview

This document from the FDA is a 510(k) premarket notification for a medical device -- a soft contact lens. It serves to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed acceptance criteria and a study report designed to prove the device meets these criteria in a typical clinical trial format for AI/ML devices. Therefore, a direct response to all your questions in the requested format for acceptance criteria and a study proving it meets them may not be fully extractable as this is not the primary purpose of this type of regulatory document.

However, I can extract information related to the device and its claimed equivalence.

Here's an attempt to answer your questions based on the provided document, recognizing the limitations of the document's nature:

Acceptance Criteria and Study for AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses

Given that this is a 510(k) premarket notification for a contact lens, the "acceptance criteria" are not presented as numerical thresholds for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly that the new device, when packaged in modified saline, performs equivalently to or better than the predicate device across critical safety and performance characteristics for contact lenses. The "study" here refers to a series of nonclinical tests demonstrating this equivalence.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (AIR OPTIX plus HydraGlyde in modified saline)
Biocompatibility: Non-toxic and non-irritating	The lens material, lens extracts, and package saline are equivalent to the predicate and remain non-toxic and non-irritating. (Nonclinical biocompatibility testing conducted in accordance with GLP 21 CFR Part 58).
Physical and Material Properties: Consistent with industry-marketed lenses and equivalent to or better than the predicate lens	Lens physical and material properties are consistent with industry-marketed lenses and equivalent to or better than the predicate lens. Specific properties are listed in "Device Description" and "Substantial Equivalence Comparison," including: - Refractive Index: 1.42 (hydrated) - Light Transmittance: > 94 % - Water Content: 33% by weight - Oxygen Permeability (Dk): 110 x 10^-11 [(cm^2/sec)(ml O2/ml mmHg)] (intrinsic Dk-Coulometric method) - Other: Plasma-treated surface, double-side molding manufacturing, visibility tint (copper phthalocyanine blue). These match the predicate device.
Compatibility with Lens Care Products: Compatible with commonly available lens care products	The device in modified saline is compatible with commonly available lens care products, like the predicate device.
Packaging & Sterilization: Maintains sterility and integrity, and lenses are effectively sterilized	Compatibility and package integrity of the blister pack packaging system have been demonstrated. Packaged lenses are effectively steam sterilized in a validated autoclave. Stability studies assessed chemical stability of the lens and package integrity. The packaging (global blister pack) and sterilization method (steam sterilization, validated autoclave) are the same as the predicate. The package storage saline solution is Phosphate buffered saline with 1% Copolymer 845 and 0.04% (400 ppm) ethylene oxide-butylene oxide (EO45BQ10) copolymer, which is a key difference from the predicate (which was Phosphate buffered saline with or without 1% Copolymer 845). The nonclinical tests confirm equivalence despite this change.
Indications for Use: Matches predicate for various lens types (spherical, toric, multifocal, multifocal toric)	Spherical: Optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and ~1.50D astigmatism. Toric: Optical correction of refractive ametropia (myopia and hyperopia) in phakic/aphakic persons with non-diseased eyes and <= 6.00D astigmatism. Multifocal: Optical correction of presbyopia with or without ametropia (myopia and hyperopia) in phakic/aphakic persons with non-diseased eyes, requiring <= +3.00D add, and ~1.50D astigmatism. Multifocal Toric: Optical correction of refractive ametropia (myopia) and presbyopia in phakic/aphakic persons with non-diseased eyes and <= 6.00D refractive and/or corneal astigmatism. Wearing Schedule: Daily disposable or daily wear with chemical disinfection. All indications are essentially the same as the predicate.

2. Sample size used for the test set and the data provenance

The document describes "nonclinical tests" performed to demonstrate equivalence. It does not provide specific sample sizes or details on "test sets" in the context of an AI/ML clinical study (e.g., patient data). The testing would have involved laboratory analyses of the lens material, extracts, and packaged solution. The provenance would be laboratory testing data, not patient data from a specific country, and it refers to physical/chemical properties rather than retrospective or prospective patient outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this 510(k) submission. "Ground truth" in the context of an AI/ML device (e.g., expert consensus on image interpretation, pathology reports) is not relevant for demonstrating substantial equivalence for a physical medical device like a contact lens. The "truth" here is established by validated laboratory testing methods and comparison to established predicate device properties and clinical performance.

4. Adjudication method for the test set

Not applicable. There's no "adjudication method" in the sense of reconciling disagreements among human readers or experts for device performance, as it's not an AI/ML diagnostic or prognostic device.

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

Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader improvement with AI are not relevant.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for the nonclinical tests is based on standardized laboratory testing methods and accepted scientific principles for evaluating the properties of contact lens materials, their biocompatibility, and sterilization effectiveness. The predicate device's established performance serves as the benchmark for equivalence. If patient data were involved in the predicate's original approval, that would likely have included clinical outcomes, but this document focuses on the new device's equivalence via nonclinical tests.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no "training set."

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

Not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2016

Alcon Laboratories, Inc. Ms. Alicia Plesnarski Director, Global Regulatory Affairs 6201 South Freeway Fort Worth, Texas 76134-2099

Re: K160609

Trade/Device Name: Air Optix Plus Hydraglyde, Air Optix Plus Hydraglyde For Astigmatism, Air Optix Plus Hydraglyde Multifocal, Air Optix Plus Hydraglyde Multifocal Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 29, 2016 Received: March 3, 2016

Dear Ms. Plesnarski:

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. 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.

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice

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requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160609

Device Name

AIR OPTIX plus HydraGlyde (lotrafilcon B) soft contact lenses

Indications for Use (Describe)

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)	☐

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510(k) SUMMARY

This summary document is being prepared in accordance with section 21 CFR 807.92.

The submitter of the 510(k) is:

Alicia M. Plesnarski, RAC Director, Regulatory Affairs, Alcon Vision Care Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 Phone: (678) 415-3924 Fax: (678) 415-3454 email: alicia.plesnarski@alcon.com

Date Summary Prepared: 12 April 2016

Device Subject to this 510(k):

Trade Name:	AIR OPTIX® plus HydraGlyde®
Common Name:	(lotrafilcon B) Soft Contact Lens
Classification Name:	Soft (hydrophilic) Contact Lens[21 CFR 886.5925 (b) (1)]
Product code:	LPL: MVN

Predicate Device(s)

The predicate device is the Alcon® AIR OPTIX® AQUA (lotrafilcon B) contact lens packaged in phosphate buffered saline (PBS) +1% Copolymer 845. Lotrafilcon B contact lenses are a Group V silicone hydrogel according to ISO 18369-1:2006/Amd. 1:2009. The predicate device (in PBS saline or PBS +1% Copolymer saline) has FDA Premarket Notification 510(k) clearance for daily wear (K033919, March 12, 2004; K073459, 28-Feb-2008).

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Device Description

Lotrafilcon B lens designs include spherical. toric, multifocal toric 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(Example: 0.08 mm for -3.00D spherical)

Lenses have the following properties:

. Refractive index: 1.42 (hydrated)
Light transmittance: > 94 % ●
Water content : 33% by weight in normal saline
Oxygen permeability 110 x 10-11 ●

[(cm2 /sec)(ml O2 /ml mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)

Indications for Use

Lotrafilcon B 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.

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Lotrafilcon B multifocal 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 have up to approximately 1.50 diopters of astigmatism.

Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia) and presbyopia in phakic or aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of refractive and/or corneal astigmatism.

Brief Summary of Nonclinical Tests and Results

A series of nonclinical tests were performed to demonstrate the substantial equivalence of lotrafilcon B contact lenses packaged with saline additive (modified saline) to the predicate device. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and ISO standards, as applicable. Results verify that lenses packaged in modified saline remain nontoxic and biocompatible and have material characteristics comparable to, or better than, other currently marketed soft contact lenses. Results from all tests demonstrate substantial equivalence to the predicate lenses.

A series of nonclinical testing was performed to verify the equivalence of lenses packaged in modified saline to the predicate device. Nonclinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58). The results of all nonclinical testing demonstrate:

. The lens material, lens extracts and package saline of the device in modified saline are equivalent to the predicate and remain non toxic and non-irritating.
Lens physical and material properties of the device in modified saline are consistent with . industry-marketed lenses and equivalent to or better than the predicate lens.

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Like the predicate device, the device in modified saline is compatible with commonly . available lens care products.

Substantial Equivalence Comparison and Conclusion

Table 1 provides a side-by-side comparison of the device in modified saline as compared to the predicate device in terms of intended use and technological information.

Table 1 Substantial Equivalence Comparison
	Predicate Devices	Device in Modified Saline
Trade Name	O2OPTIX®	AIR OPTIX® AQUA	AIR OPTIX® plus HydraGlyde®
Submission Number	K033919/P010019/S003	K073459 /P010019/S008	510(k) # to be assigned
Device Classification Name	Daily Wear Soft Contact Lens 21 CFR 886.5925 (b) (1)	Same	Daily Wear Soft Contact Lens21 CFR 886.5925 (b) (1)
	Extended Wear Soft Contact Lens21 CFR 886.5925 (b) (2)	Same	--
Intended Use	Vision correction	Same	Same
Wearing Schedule	Daily wear and extended wear up to six nights	Same	Daily wear
Replacement Schedule	Up to one month	Same	Same
Material Classification	Group V (silicone hydrogel) soft contact lens material according to ISO 18369-1:2006/Amd.1:2009	Same	Same
Lens Material	Lotrafilcon B	Same	Same
Surface Treatment	Plasma treated	Same	Same
Manufacturing Method	Double-side molding	Same	Same
Visibility Tint	Copper phthalocyanine blue	Same	Same
	Predicate Devices		Device in Modified Saline
Lens Designs	Spherical, toric,multifocal, multifocaltoric	Same	Same
Power Range	+20.00 to -20.00D	Same	Same
Base Curve Range	8.0 to 9.2 mm	Same	Same
Diameter Range	13.0 to 15.0 mm	Same	Same
Water Content	33%	Same	Same
Refractive Index	1.422	Same	Same
OxygenPermeability	~110*	Same	Same
Sterilization	Steam sterilization,validated autoclave	Same	Same
Packaging	Global blister pack	Same	Same
Package StorageSaline Solution	Phosphate bufferedsaline	Phosphatebuffered salinewith (orwithout)1% Copolymer845	Phosphate buffered salinewith 1% Copolymer 845and0.04% (400 ppm) ethyleneoxide-butylene oxide(EO45BQ10) copolymer

Table 1 Substantial Equivalence Comparison

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Table 1 Substantial Equivalence Comparison

*Dkc, boundary layer corrected Dk single point coulometric method (barrer units)

Lotrafilcon B soft contact lenses packaged in modified saline are equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of technological characteristics and intended use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen.

Any differences which may exist between lotrafilcon B soft contact lenses packaged in modified saline and the predicate device or other Group V silicone hydrogel soft contact lenses do not adversely affect the safety and effectiveness of the 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.