Bausch + Lomb kalifilcon A Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

Kalifilcon A Contact Lens for Astigmatism

Bausch + Lomb kalifilcon A Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.

The kalifilcon A contact lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.

Device Description

The Bausch + Lomb kalifilcon A material is made from a hydrophilic siloxane copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with 0.5% poloxamine solution. A UVabsorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246.

The Bausch + Lomb kalifilcon A Contact Lens is to be prescribed for single-use disposable wear.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens and for Astigmatism. The document reviews the substantial equivalence of the new device to a legally marketed predicate device.

Based on the nature of this document (a 510(k) summary for a contact lens), it does not contain the detailed information typically provided for the acceptance criteria and study proving an AI/ML-based medical device meets those criteria. The information requested in the prompt (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, AI effect size, etc.) is specific to the validation of AI/ML algorithms.

This document describes the equivalence of a physical medical device (contact lens) and focuses on its physical properties, material composition, manufacturing, and clinical performance related to its function as a contact lens (e.g., correction of refractive error, comfort, safety like slit lamp findings).

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a clinical study for a standard medical device, not an AI/ML algorithm.

However, I can extract information related to the clinical study conducted for the contact lens, which might partially align with some general aspects of your request, but it won't be AI/ML-specific.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria with numerical thresholds for the contact lens's performance in the way an AI model's metrics (e.g., sensitivity, specificity, AUC) would be presented. Instead, it states the achievement of primary endpoints.

Acceptance Criteria (Stated Goal)	Reported Device Performance
Primary Safety Endpoint: Any slit lamp finding greater than Grade 2 over the course of the study avoided.	Achieved: "All primary endpoints were achieved, and the results of the study indicate the test lens is safe and effective."
Primary Efficacy Endpoint: Contact lens corrected distance high-contrast visual acuity averaged over all scheduled visits.	Achieved: "All primary endpoints were achieved, and the results of the study indicate the test lens is safe and effective."

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

Sample Size: "approximately 247 patients"
Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). It was a "controlled clinical study," implying prospective data collection for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept (experts establishing ground truth) is not directly applicable in the context of a contact lens clinical trial in the same way it is for an AI algorithm interpreting images. The "ground truth" for contact lens performance is established through direct measurements, patient reported outcomes, and clinical assessments by optometrists/ophthalmologists involved in the study. The number of such clinicians and their specific qualifications are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/mentioned for a contact lens clinical trial in the context of diagnostic interpretation. Clinical trial data collection involves standardized examinations and measurements by clinicians. How disagreements among clinicians (if any) were handled is not described.

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 was a clinical study comparing a new contact lens to a predicate contact lens, not an AI system. No human reader improvement with AI assistance is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
For safety, the ground truth was based on slit lamp findings assessing ocular health (e.g., signs of inflammation, corneal issues). For efficacy, the ground truth was based on visual acuity measurements with the contact lenses. These are direct clinical observations and measurements.

8. The sample size for the training set:
Not applicable. This refers to the training of an AI model, not a physical device.

9. How the ground truth for the training set was established:
Not applicable. This refers to the training of an AI model, not a physical device.

In summary, as this document pertains to a conventional medical device (contact lens) and not an AI/ML algorithm, most of the specific questions regarding AI validation criteria cannot be answered.

Summary

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June 02, 2020

Bausch + Lomb, Incorporated Barbara Klube-Falso Director, Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

Re: K200528

Trade/Device Name: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: Mav 4, 2020 Received: May 6, 2020

Dear Barbara Klube-Falso:

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/cdrh/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.

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

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(21 CFR Part 801); medical device reporting (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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K200528

Device Name

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism

Indications for Use (Describe)

Kalifilcon A Contact Lens

Kalifilcon A Contact Lens for Astigmatism

Bausch + Lomb kalifilcon A Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with non-diseased eves, exhibiting astigmatism of up to 5.00 diopters.

The lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.

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 K200528

Submitter Information:

Date Prepared:	May 4, 2020
Name:	Bausch & Lomb Incorporated
Address:	1400 North Goodman StreetRochester, NY 14609
Contact Person:	Barbara Klube-FalsoDirector, Regulatory Affairs
Phone Number:	(585) 338-8503
Email:	Barbara.Klube-Falso@bausch.com

Device Information:

Trade Name:	Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens
	Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for
	Astigmatism

Regulation Name: Soft (hydrophilic) Contact Lens

Device Classification: Class II (21 CFR 886.5925)

Predicate Device:

Bausch + Lomb kalifilcon A Contact Lens is substantially equivalent to the following predicate device:

Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens cleared under K113703.

Device Description :

The Bausch + Lomb kalifilcon A Contact Lens is to be prescribed for single-use disposable wear.

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The physical properties of the lens are:

Refractive index	1.4011
Light transmission	97%
Water Content	55%
Specific Gravity	1.029
Oxygen Permeability	107 x 10-11[cm³O₂(STP) x cm]/(sec x cm² xmmHg)@35°C (polarographic method)

The lenses will be manufactured with the following parameters:

Diameter	13.5mm to 15.0mm
Center Thickness	0.05mm to 0.75mm
Base Curve	7.8mm to 9.5mm
Power Range	+20.00D to -20.00D
Cylinder Power (Toric)	-0.75D to -5.00D
Cylinder Axis	0° to 180º

The lenses are packaged in disposable blister packages containing phosphate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process.

Intended Use:

Kalifilcon A Contact Lens

Kalifilcon A Contact Lens for Astigmatism

The kalifilcon A contact lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.

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Technological Characteristics (comparison to predicate devices)

A side-by-side comparison of the predicate devices to the new device:

Property	Predicate DeviceBausch + LombBiotrue ONEday (nesofilcon A)Contact Lens	Subject DeviceBausch + Lombkalifilcon A Contact Lens
Intended Use	Indicated for the daily wearcorrection of refractiveametropia (myopia, hyperopiaand astigmatism) in aphakicand/or non-aphakic personswith non-diseased eyes thatexhibit refractive astigmatism upto 2.00 diopters or less, thatdoes not interfere with visualacuity. The lens is to beprescribed for single-usedisposable wear and is to bediscarded after each removal.	Same as predicate
Functionality	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina.	Same as predicate
Modality	Daily wear contact lens	Same as predicate
ManufacturingMethod	Cast Molded	Same as predicate
Material Group	Group IIHydrogel(high water, non-ionic)	Group 5-BSilicone Hydrogel(high water, non-ionic)
USAN Name	nesofilcon A	kalifilcon A
Water Content	78%	55%
OxygenPermeability1(edge corrected)	42	107
Specific Gravity	1.039	1.029
UV Blocker	Yes	Yes

1- Oxygen Permeability shown was determined by the polarographic method: x 10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C

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Summary of Non-Clinical Testing:

The testing performed on the Bausch + Lomb kalifilcon A Contact Lens demonstrated that the device functions in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user.

In addition, Bausch + Lomb followed the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994, the following tests were conducted:

Toxicology / Biocompatibility

In-Vitro Cytotoxicity

Ocular Irritation Study

Systemic Toxicity

Chemistry / Leachables

Physical, Chemical and Spectral Properties

Leachable Monomer and Additives

Summary of Clinical Performance Data

Bausch + Lomb conducted a 3 month, controlled clinical study with approximately 247 patients, comparing the safety and efficacy of the Bausch + Lomb kalifilcon A Contact Lens to the Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens.

The primary safety endpoint was any slit lamp finding greater than Grade 2 over the course of the study. the primary efficacy endpoint was contact lens corrected distance high-contrast visual acuity averaged over all scheduled visits. All primary endpoints were achieved, and the results of the study indicate the test lens is safe and effective,

Substantial Equivalence Conclusion:

The cumulative results of laboratory, in vitro, in vivo testing as well as the clinical study sponsored by Bausch + Lomb demonstrate that the safety. effectiveness and performance of the Bausch + Lomb kalifilcon A Contact Lens are substantially equivalent to the Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens.

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.