BAUSCH & LOMB® SofLens™ MulfiFocal (polymacon) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +1.00D to +5.00D.

Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

Device Description

The BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a polymer of hydroxyethyl methacrylate (HEMA) and crosslinked with Ethyleneglycol Dimethacrylate (EGDMA), and is 38% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246 ((1,4-Bis[4-(2methacryloxyethyl) phenylamino] anthraquinone). The color additive conforms with 21 CFR Part 73.3106.

The physical / optical properties of the lens are:
Specific Gravity: 1.15
Refractive Index: 1.4375
Light Transmittance: C.I.E. Y value - at least 96%
Water Content: 38%
Oxygen Permeability (Dk): 8.4 x 10 to the power of -11 [cm cubed O sub 2 (STP) x cm]/(sec x cm squared x mmHg)@35°C (Polarographic Method)

The BAUSCH & LOMB SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
Diameter: 13.5mm to 15.5mm
Center Thickness: 0.05mm to 0.75mm
Base Curve: 7.5mm to 9.5mm
Powers (Spherical): +20.00D to -20.00D
Add Power: +1.00D to +5.00D

Each BAUSCH & LOMB SofLens™ Multifocal (polymacon) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter, add (high/low) and expiration date.

AI/ML Overview

The provided text describes a 510(k) summary for the BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens. The information largely focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a detailed report of acceptance criteria and a study proving device performance against those criteria in the way typically expected for an AI/software device.

However, I can extract the relevant information and structure it to the best of my ability based on the provided document.

Acceptance Criteria and Reported Device Performance

The study compares the SofLens™ MultiFocal (Test lens) to the Johnson & Johnson Acuvue® Bifocal Contact Lens (Control lens) in a randomized clinical study. The acceptance criteria and the "device performance" are framed in terms of achieving non-inferiority or statistical equivalence to the control lens.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (SofLens™ MultiFocal vs. Acuvue® Bifocal)
Safety	No statistical difference in the frequency of occurrence of total grade 2 or greater positive slit lamp findings between the study lenses.	"There were no significant differences between the Test and Control lenses with respect to the frequency of occurrence of total grade 2 or greater slit lamp findings. Therefore, the safety end-point defined in the protocol was achieved."
Efficacy	No statistical difference in the proportion of lens visual acuities worse than 20/40 between the Test and Control lenses.	"There were no significant differences in the proportion of lens visual acuities worse than 20/40 between Test and Control lenses. Therefore, the efficacy end-point defined in the protocol was achieved."
Conclusion	The Bausch & Lomb Castmold Bifocal Contact Lens is equivalent in safety and efficacy to the Johnson & Johnson Acuvue Bifocal Contact Lens.	"The Sponsor concludes, based on the data presented, that the protocol-specified endpoints were achieved, and that the Bausch & Lomb Castmold Bifocal Contact Lens is equivalent in safety and efficacy to the Johnson & Johnson Acuvue Bifocal Contact Lens, when worn on a daily wear basis."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: A total of 170 eyes (85 patients) were entered into the study. 166 eyes (83 patients) completed the study.
- Data Provenance: The study was a "one month, randomized clinical study" which implies a prospective clinical trial. The country of origin of the data is not explicitly stated but is implicitly within the scope of FDA approval for a US-based manufacturer (Bausch & Lomb, Rochester, NY).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states, "A total of 170 eyes (85 patients) were entered into the study by 6 Investigators." These investigators would be the experts assessing the clinical endpoints (slit lamp findings, visual acuity). Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but it's implied they are qualified eye care professionals capable of conducting such a clinical study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method. Data collection for slit lamp findings and visual acuity would typically be performed by the investigators directly.
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:
- This was not an MRMC study and does not involve AI. It is a clinical comparison of two physical contact lenses.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This was not an AI or algorithmic device. It's a medical device (contact lens) where human clinical assessment (by investigators) is inherently part of the performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the safety endpoint was based on a "no statistical differences" finding in the frequency of "total grade 2 or greater positive slit lamp findings," which represent clinical observations made by the investigators.
- The "ground truth" for the efficacy endpoint was based on "no statistical difference in the proportion of lens visual acuities worse than 20/40," which are measured clinical outcomes.
- Therefore, the ground truth is clinical observations and measured visual acuity, assessed by qualified investigators.
The sample size for the training set:
- This concept is not applicable, as this is a clinical study for a physical medical device, not an AI or machine learning algorithm requiring a "training set."
How the ground truth for the training set was established:
- Not applicable as there is no training set for this type of device.

Summary

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K020927

MAY 1 6 2002

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens

1. Submitter Information:

Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609

Contact Person:Debra Ketchum Manager, Regulatory Affairs (585) 338-8638 Telephone No .:

Device Name: 2.

Classification Name: Soft (hydrophilic) contact lens

BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Proprietary Name: Visibility Tinted Contact Lens

3. Predicate Devices:

(N16-895) Optima™ FW (polymacon) Visibility Tinted Contact Lens Unilens EMA (polymacon) Soft Bifocal Contact Lens (K960926) Acuvue Bifocal (etafilcon A) Contact Lens (K962804)

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DESCRIPTION OF DEVICE 4.

The physical / optical properties of the lens are:

Specific Gravity:	1.15
Refractive Index:	1.4375
Light Transmittance:	C.I.E. Y value - at least 96%
Water Content:	38%
Oxygen Permeability (Dk):	$8.4 \times 10^{-11} [cm^3 O_2(STP) \times cm]/(sec \times cm^2 \times mmHg)@35°C$(Polarographic Method)

The BAUSCH & LOMB SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:

Diameter:	13.5mm to 15.5mm
Center Thickness:	0.05mm to 0.75mm
Base Curve:	7.5mm to 9.5mm
Powers (Spherical):	+20.00D to -20.00D
• Add Power	+1.00D to +5.00D

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5. INDICATIONS FOR USE

BAUSCH & LOMB® SofLens™ MulfiFocal (polymacon) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or notaphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +1.00D to +5.00D.

Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve and discarded after the recommended wearing period prescribed by the eve care practitioner. The lens may be disinfected using a chemical disinfection system.

DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE 6.

A series of non-clinical laboratory testing and clinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB SofLens Multifocal (polymacon) Contact Lens. A summary of results from the preclinical and clinical tests is provided below.

Non-Clinical Laboratory Testing:

A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens device. Testing was performed in accordance with FDA guideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. All non-clinical laboratory studies were conducted in compliance with the GLP requlation. The non-clinical laboratory testing can be found in N16-895. Supplement 74, approved August 13, 1991.

Stability testing has demonstrated a three year expiration date for the sterile lenses.

Clinical Testing:

A one month, randomized clinical study was completed to evaluate the safety and efficacy of the Bausch & Lomb Castmold Bifocal Contact Lens (Test) compared to the Johnson & Johnson Acuvue® Bifocal Contact Lens (Control) when worn on a daily wear basis.

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At the Initial Dispensing Visit, eligible patients were dispensed a Bausch & Lomb Castmold Bifocal (Test) Contact Lens or Johnson & Johnson Acuvue® Bifocal (Control) Contact Lens according to randomization tables supplied to the Investigators. The identity of the study sponsor was not revealed to the patient. A total of 170 eyes (85 patients) were entered into the study by 6 Investigators. Of the 170 eves (85 patients) enrolled, 166 eyes (83 patients) completed the study.

The primary endpoints were:

Sa No statistical differences between the study lenses with respect to the . fet frequency of occurrence of total grade 2 or greater positive slit lamp findinas. v:
Effic No statistical difference in the proportion of lens visual acuities worse . acy: than 20/40 between the Test and Control lenses.

There were no significant differences between the Test and Control lenses with respect to the frequency of occurrence of total grade 2 or greater slit lamp findings. Therefore, the safety end-point defined in the protocol was achieved.

There were no significant differences in the proportion of lens visual acuities worse than 20/40 between Test and Control lenses. Therefore, the efficacy end-point defined in the protocol was achieved.

The Sponsor concludes, based on the data presented, that the protocol-specified endpoints were achieved, and that the Bausch & Lomb Castmold Bifocal Contact Lens is equivalent in safety and efficacy to the Johnson & Johnson Acuvue Bifocal Contact Lens, when worn on a daily wear basis. The Castmold Bifocal Contact Lens is a safe and effective means of daily wear vision correction.

Substantial Equivalence

The BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is similar to the BAUSCH & LOMB® Optima FW (polymacon) Visibility Tinted Contact Lens, in that both fall into the same FDA material classification grouping (Group I), have the same USAN name and both are manufactured by the same manufacturing process (castmolding). The BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is different from the BAUSCH & LOMB® Optima FW (polymacon) Visibility Tinted Contact Lens in that it has a multifocal indication. The BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is similar to the Unilens EMA (polymacon) Soft Bifocal Contact Lens, in that both fall into the same FDA material classification grouping (Group I), have a multifocal indication and have the same USAN name. The BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Tinted Contact Lens is similar to Acuvue Bifocal (etafilcon A) Contact Lens in that both have the same multifocal indication.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and sides of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra L. Ketchum Manager, Regulatory Affairs Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609

Re: K020927

Trade/Device Name: BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility

Tinted Contact Lens Regulation Number: 886.5925 Regulation Name: Soft (hydrophilic) contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 19, 2002 Received: March 21, 2002

Dear Ms. Ketchum:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 forth 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.

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Page 2- Ms. Debra L. Ketchum

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information 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

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Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609

Indications for Use Statement

510(k) Number (if known):

BAUSCH & LOMB® SofLens™ MultiFocal (polymacon) Visibility Device Name: Tinted Contact Lens

Indications for Use:

BAUSCH & LOMB® SofLens™ MulfiFocal (polymacon) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +1.00D to +5.00D.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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Over-The-Counter-Use
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Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K020927
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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.