Focus® Excelens™ (Iotrafilcon 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 with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

Focus® Excelens™ Toric (Iotrafilcon B) 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 6.00 diopters (D) or less of astigmatism.

Focus® Excelens™ Progressives (Iotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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 of astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Device Description

The material used for (lotrafilcon B) soft contact lenses is a modification to the lens material used for (lotrafilcon A) lenses. The lens material is 33% water and 67% lotrafilcon B, a silicone containing hydrogel which is surface treated.

Lotrafilcon B lens designs include spherical, toric and multifocal 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 power (0.080 mm for -3.00D spherical)
Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.

Lenses have the following properties:
. Refractive index: 1.42 (hydrated)
● Light transmittance: > 96 %
. Water content : 33 % by weight in normal saline
. Oxygen permeability 110 x 10 *1 [(cm2 /sec)(ml O2 /ml+mmHg)] measured at 35°C (intrinisic Dk-Coulometric method)

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marked packaging System has boon domenstare effectively steam sterilized in a validated lens products, and puonagou lensors are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability and product oxpiration dater the chemical stability of the lens and package integrity (ability to maintain sterility). Stability study data currently supports a twenty four (24) (ablity to maint of the for (lotrafilcon B) soft contact lenses in sealed blister pack containers. Shelf-life studies are ongoing to determine extension of expiration dating.

AI/ML Overview

Here's an analysis of the provided text regarding the Lotrafilcon B Soft Contact Lenses to address your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission for substantial equivalence, not a detailed clinical study with specific quantitative acceptance criteria or performance metrics in a table format as you might expect from a rigorously designed clinical trial for a novel device. Instead, the "acceptance criteria" are implied by the demonstration of "safety and effectiveness" and "substantial equivalence" to a predicate device. The performance is reported in general qualitative terms.

Here's an interpretation based on the document:

Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical & Biocompatibility:
1. Non-toxic and non-irritating (material & extracts)	"The lens material and extracts are not toxic and non-irritating."
2. Consistent physical and material properties (with industry standard and predicate)	"Lens physical and material properties are consistent with industry marketed lenses, and similar to lotrafilcon A lenses." Properties include: Refractive index (1.42), Light transmittance (> 96%), Water content (33%), Oxygen permeability (110 x 10^-11 [(cm^2/sec)(ml O2 /ml+mmHg)])
3. Compatibility with lens care products	"The lens material remains unaffected, with respect to lens properties, by exposure to common cleaning and disinfection systems, and is compatible with commonly available lens care products."
4. Package integrity and sterility over shelf life	"The compatibility and package integrity of the blister pack packaging system has been demonstrated... and lenses are effectively steam sterilized in a validated system... Stability study data currently supports a twenty-four (24) month shelf-life for (lotrafilcon B) soft contact lenses..."
Clinical Performance (Daily Wear):
1. Safety (compared to predicate control lens)	"The study assessed the safety and effectiveness, and clinical performance as compared to the predicate control lens." "Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions."
2. Effectiveness (compared to predicate control lens)	"The study assessed the safety and effectiveness, and clinical performance as compared to the predicate control lens." "Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions." Indications for Use cover spherical, toric, and progressive lenses for ametropia (myopia, hyperopia) and presbyopia, with specific astigmatism and add power limits.
3. Substantial equivalence to predicate	"Results from all tests demonstrate the Substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses." "The (lotrafilcon B) contact lens is similar to other daily wear soft contact lenses in terms of water content (33% water) and ionic characteristics (FDA Group I: low water, nonionic polymer), optical performance, and indications for use." "Any differences which may exist... does not adversely effect the safety and effectiveness of the device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size for the clinical test set (i.e., the number of patients or eyes enrolled in the "daily wear clinical study"). It only mentions "The one-month clinical evaluation was conducted..."
Data Provenance: The study was a "daily wear clinical study," indicating it was prospective. The location is not specified, but the applicant (CIBA Vision Corporation) is located in Duluth, Georgia, USA. The study was conducted "in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812)," which are US regulations, suggesting the study was likely conducted in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no information provided regarding "experts used to establish ground truth" in the context of typical diagnostic or image-based AI studies. This is a contact lens study, where clinical endpoints (vision, health, comfort, fit) are likely assessed by the investigating optometrists/ophthalmologists directly managing the patients in the trial, rather than independent experts reviewing data. The document does not detail individual expert qualifications or number for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of clinical study for a contact lens. Clinical outcomes were assessed over time during the one-month evaluation.

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 is a study evaluating the safety and effectiveness of a contact lens itself, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was the clinical assessment of safety and effectiveness parameters (vision, health, comfort, and fit) in patients wearing the contact lenses over a one-month daily wear period, particularly in comparison to a predicate device (lotrafilcon A). This would involve direct observation, patient-reported outcomes, and standard ophthalmic measurements. Non-clinical "ground truth" involved established toxicology, biocompatibility, and material property testing standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI model or algorithm being trained described in this document.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI model or algorithm being trained described in this document.

Summary

{0}------------------------------------------------

APR o 9 2002

11 020139

CIBA Vision® Corporation 28-Mar-02, v02 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Page 1 of 4 Lotrafilcon B Soft Contact Lenses 510(k) - K020139 Summary of Safety and Substantial Equivalence 510(k) Summary

1. Submitter Information:

Company:	CIBA Vision Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097
Contact Person:	Alicia M. Plesnarski, RACSenior Specialist, Global Regulatory Affairs
Telephone:FAX:Date Prepared:	678-415-3924678-415-433328 March, 2002

2. Device Name:

Soft Contact Lens Common Name: . Focus® Excelens™ (lotrafilcon B) Trade/Proprietary Name: . Daily Wear Soft Contact Lens Classification Name: ●
Class II [21 CFR 886.5925 (b) (1)] . Device Classification:

3. Predicate Device:

The Focus® Excelens™ (lotrafilcon B) lens is a modification of the predicate device, (lotrafilcon A) soft contact lens. Both are in FDA Group 1 (low water, nonionic polymer). CIBA Vision obtained FDA 510(k) clearance for daily wear on May 9, 1997 (K970746) and FDA PMA marketing approval for extended wear on October 11, 2001 (P010019) for (lotrafilcon A) lenses.

4. Description of Device:

Lotrafilcon B lens designs include spherical, toric and multifocal 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

varies with power (0.080 mm for -3.00D spherical) ● Center Thickness:
Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.

{1}------------------------------------------------

Image /page/1/Picture/0 description: This image shows a document from CIBA Vision Corporation, located at 11460 Johns Creek Parkway in Duluth, Georgia, USA 30097. The document is dated 28-Mar-02, version v02, and is page 2 of 4. The document is titled "Lotrafilcon B Soft Contact Lenses" and includes the text "510(k) - K020139 Summary of Safety and Substantial Equivalence".

Lenses have the following properties:

1.42 (hydrated) Refractive index: .
96 % Light transmittance: ●
33 % by weight in normal saline Water content : .
110 x 10 *1 Oxygen permeability .

[(cm2 /sec)(ml O2 /ml+mmHg)]

measured at 35°C (intrinisic Dk-Coulometric method)

5. Indications for Use:

Focus® Excelens™ (Iotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic opersons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

Focus® Excelens™ Toric (lotrafilcon B) soft contact lenses are indicated for the optical r ouds Exection of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

Focus® Excelens™ Progressives (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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 of astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

{2}------------------------------------------------

CIBAVision.A Novartis Company	CIBA Vision® Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097	28-Mar-02, v02Page 3 of 4
----------------------------------------------------------------------------------	------------------------------------------------------------------------------------	-------------------------------

Lotrafilcon B Soft Contact Lenses# 510(k) - K020139 Summary of Safety and Substantial Equivalence

6. Description of Safety and Substantial Equivalence:

A series of non-clinical tests and clinical studies were performed to demonstrate the safety and effectiveness of the (lotrafilcon B) contact lens, and establish substantial equivalence to a currently marketed, predicate (intrastition A) control lens. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket was conducted in accordance for Class II Contact Lenses and in conformance to applicable device regulations. Results demonstrate the lens is non-Conformatible, and has material characteristics comparable to or better than other currently marketed soft contact lenses. Clinically, the lens has performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the Substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses.

Nonclinical Testing:

A series of in vitro and in vivo pre-clinical toxicology and biocompatibility testing was A senes of in viro and in the pro official toxocogy and ontaction (of non-clinical performed to assess the barety and crordance with the GLP regulation (21 CFR Part 58).

The results of the non-clinical testing on the (lotrafilcon B) contact lens demonstrate:

The lens material and extracts are not toxic and non- irritating. .
Lens physical and material properties are consistent with industry marketed lenses, . and similar to lotrafilcon A lenses.
The lens material remains unaffected, with respect to lens properties, by exposure . The lens material cleaning and disinfection systems, and is compatible with commonly available lens care products.

Clinical Testing:

The (lotrafilcon B) contact lens was investigated in daily wear clinical study. The onemonth clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812). The study assessed the safety and effectiveness, and clinical performance as compared to the predicate control lens.

Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions.

{3}------------------------------------------------

CIBAVision.A Novartis Company	CIBA Vision ® Corporation11460 Johns Creek ParkwayDuluth, Georgia USA 30097	28-Mar-02, v02Page 4 of 4
Lotrafilcon B Soft Contact Lenses510(k) - K020139 Summary of Safety and Substantial Equivalence

Substantial Equivalence:

The (lotrafilcon B) contact lens is similar to other daily wear soft contact lenses in terms of water content (33% water) and ionic characteristics (FDA Group I: low water, or water ochical performance, and indications for use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen.

Any differences which may exist between the (lotrafilcon B) soft contact lens and other Any androinood million plastic contact lenses does not adversely effect the safety and effectiveness of the device.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

APR - 9 2002

CIBA Vision Corporation c/o Alicia M. Plesnarski, RAC 11460 Johns Creek Parkway Duluth, GA 30097

Re: K020139

Trade/Device Name: Focus Excelens (lotrafilcon B) Soft Contact Lenses Regulation Number: 21CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: January 15, 2002 Received: January 16, 2002

Dear Ms. Plesnarski:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in 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 I va may , and severy anions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your avisor to such 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); good manufacturing practice requirements as set Erth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 - Alicia M. Plesnarski, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w your e FDA finding of substantial equivalence of your device to a legally premailed noutreation - results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 1 Far 3613. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 + + t the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director · Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

{6}------------------------------------------------

Indications for Use Statement, v02, 28-Mar-02, Page 1 of 1 Premarket Notification 510(k): (Iotrafilcon B) Soft Contact Lens for Daily Wear

INDICATIONS FOR USE STATEMENT

510(k) Number:

K020139

Device Name:

Focus® Excelens™ (lotrafilcon B) Soft Contact Lenses

Indications For Use:

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lancel W.C. Brown, Ph.D.

ion of Ophthalmic Ear. Nose and Throat Devises

K020139 510(k) Number

Prescription Use:

Over the Counter Use

门

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.