The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prostheric contact leases for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.

The OXYLENS TINTED (hioxifilcon B) Spherical Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected with either a chemical or a heat disinfection system.

The OXYLENS TINTED (hioxifileon B) Toric Soft Contact Leases for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.

The leases are available within a planned replacement program with frequency of replacement determined by the practitioner.

Device Description

The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Contact Lens is fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A tint mixture containing; Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17 -Dimethoxydinaphtho [1.2.3 -cd:3'.2'.1' -lm] pervlene-5,10-dione, and Brown 16,23 -Dihydrodinaphtho [2,3-a.2 ] 3 ' -i] napth [2',3' ; 6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.

The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Tint Patterns Available:

1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
1. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
1. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
1. Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

The OXYLENS TINTED may contain a single listed color additive, or may contain a combination of color additives in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The color additives are added to the contact lens for enhancing and/or altering the apparent color of the eve.

In the hydrated state, the OXYLENS TINTED, PROSTHETIC lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a color altering optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

The provided text is a 510(k) summary for the OXYLENS TINTED, PROSTHETIC (hioxifilcon B) Soft Daily Wear Contact Lens. This document demonstrates that the device is substantially equivalent to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested elements about acceptance criteria, clinical studies, sample sizes, ground truth, and expert involvement are not applicable as this type of submission relies on demonstrating substantial equivalence to existing devices with established safety and effectiveness.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

1. A table of acceptance criteria and the reported device performance

There are no explicit "acceptance criteria" presented in the format of a clinical study or performance goals that the device had to meet. The submission focuses on demonstrating substantial equivalence to predicate devices based on material characteristics and intended use. The table below summarizes the characteristics of the proposed device and its predicates, serving as the basis for the substantial equivalence claim.

Table of Device Characteristics and Predicate Comparison

Characteristic	OXYLENS PROSTHETIC (hioxifilcon B)	OXYLENS TINTED (hioxifilcon B)	PREDICATE DEVICE(S)
Production Method	Lathe-Cut	Lathe-Cut	Lathe-Cut
Material	Hydrophilic Polymer	Hydrophilic Polymer	Hydrophilic Polymer
Water Content	48%	48%	38%, 48%
Polymer Content	52%	52%	62%, 52%
Polymer	hioxifilcon B	hioxifilcon B	Polymacon, hioxifilcon B
DK Value (Oxygen Permeability)	15	15	9, 15
Refractive Index (hydrated)	1.404	1.404	1.430, 1.404
Specific Gravity (hydrated)	1.136	1.136	1.18, 1.136
Light Transmission	greater than 70% T (N/A for non-sighted eyes)	greater than 70% T	greater than 70% T
Color Additives	Vat Green 1, Vat Brown 1, Vat Blue 6	Vat Green 1, Vat Brown 1, Vat Blue 6, Vat Yellow 3, Vat Orange 1	Vat Blue 6 (for predicate); Not Applicable for Clear Contact Lens
Lens Function	Enhance/alter eye color, ocular masking, refractive error correction (ametropia, astigmatism), occlusive therapy.	Refractive medium, enhancing/altering eye color.	Enhance/alter eye color, ocular masking, refractive error correction (ametropia, astigmatism), occlusive therapy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) submission does not include a clinical study with a test set of data. The submission demonstrates substantial equivalence based on the device's design, materials, and intended use being similar to already approved predicate devices. It references "pre-clinical toxicology and manufacturing/chemistry data" but does not detail any specific human clinical testing for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth establishment by experts for a test set is described, as no specific clinical study data is presented for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As no clinical study or test set is described, there is no adjudication method.

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 not an AI-assisted device, and no MRMC study or comparative effectiveness study is presented in the 510(k) summary.

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

Not Applicable. This device is a contact lens and does not involve an algorithm.

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

Not Applicable. No explicit ground truth based on expert consensus, pathology, or outcomes data is mentioned as there is no specific clinical study for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness profiles of the predicate devices and the similarity of the new device to them.

8. The sample size for the training set

Not Applicable. This involves a physical medical device (contact lens), not a machine learning algorithm requiring a training set.

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

Not Applicable. See response to item 8.

Summary

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K983278

Applicant information:

Date Prepared:	September 14, 1998
Name:	Alden Optical Laboratories
Address	13295 BroadwayAlden, New York 14004
Contact Person:	Charles H. Creighton
Phone Number:	800.253.3669
USA Consultant:	MedVice Consulting, Inc.
Phone Number:	Martin Dalsing(970) 243-5490

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Trade Name:	OXYLENS TINTED, PROSTHETIC (hioxifilcon B), SoftDaily Wear Contact Lens, Tinted (lathe-cut)
Classification Name:	Lenses, Soft Contact, Daily Wear

Substantially Equivalent Devices:

The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Daily Wear Contact Lens, Tinted (lathecut) is substantially equivalent to the "ALDEN CLASSIC PROSTHETIC" (polymacon) Tinted, Soft Contact lens (lathe-cut) and the BENZ-G 3X (hioxifilcon B) Soft (Spherical and Toric) Daily Wear Contact Lens, the predicate devices.

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Device Descriptive Characteristics:

Tint Patterns Available:

1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
1. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
1. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
1. Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

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The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight. The physical properties of the lens are:

Refractive Index	1.515 (dry) 1.404 (hydrated)
Light Transmission:	greater than 70% T *
Water Content	48 %
Specific Gravity	1.308 (dry) 1.136 (hydrated)
Color additives	Vat Brown 1, Vat Blue 6, Vat Green 1, Vat Yellow3, Vat Orange 1
Oxygen Permeability	15 X 10-11 Fatt Units (cm2/sec)(ml O2/ml x mm Hg @ 35°C), (revised Fatt method)

- Patients may experience a reduction in visibility while wearing a dark shade of lens in conditions of low illumination.

Intended Uses:

The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eve color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, in's or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.

The OXYLENS TINTED (hioxifilcon B) Toric Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.

The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

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Substantial Equivalence:

The devices will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Alden Optical Laboratories. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the devices is equivalent to the Alden Classic Tinted (polymacon) 510(k) #K980554, the Oxylens (hioxifilcon B) 510(k) # K981252 and the Benz-G 3X (hioxifilcon B) 510(k) # K964528. Being similar with respect to materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

The following matrix illustrates the production methods, lens functions and material characteristics of the OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Daily Wear Contact Lens (lathe-cut), as well as the predicate devices.

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Substantial Equivalence Matrix

	Characteristic	OXYLENSPROSTHETIC	OXYLENS TINTED	PREDICATEDEVICE(S)
1.)	PRODUCTIONMETHOD	Lathe-Cut	Lathe-Cut	Lathe-Cut
2.)	LENS FUNCTION	Enhance or alter theapparent eye color,including ocular masking,either in sighted or non-sighted eyes that require aprosthetic contact lenses forcosmetic management ofconditions such as corneal,iris or lens abnormalities.The lens may also beprescribed for the correctionof refractive ametropia(myopia, hyperopia andastigmatism) in aphakic andnot aphakic persons or forocclusive therapy forconditions such as diplopia,amblyopia or extremephotophobia.	Refractive medium thatfocuses light rays from nearand distant objects on theretina, while compensatingfor refractive error,including (astigmatism),including enhancing and/oraltering the apparent eyecolor.	Enhance or alter theapparent eye color,including ocular masking,either in sighted or non-sighted eyes that require aprosthetic contact lenses forcosmetic management ofconditions such as corneal,iris or lens abnormalities.The lens may also beprescribed for the correctionof refractive ametropia(myopia, hyperopia andastigmatism) in aphakic andnot aphakic persons or forocclusive therapy forconditions such as diplopia,amblyopia or extremephotophobia.
3.)	MATERIAL	Hydrophilic Polymer	Hydrophilic Polymer	Hydrophilic Polymer
a.	Water Content	48%	48%	38%, 48%
b	Polymer Content	52%	52%	62%, 52%
C	Polymer	hioxifilcon B	hioxifilcon B	Polymacon, hioxifilcon B
d.	DK Value	15	15	9, 15
e	Refractive Index	1.404 (hydrated)	1.404 (hydrated)	1.430, 1.404 (hydrated)
f	Specific Gravity	1.136 (hydrated)	1.136 (hydrated)	1.18, 1.136 (hydrated)
g	Light Transmission	greater than 70 % T(N/Afor non-sighted eyes)	greater than 70 % T	greater than 70 % T
h.	Color Additives	Vat Green 1, Green (21CFR 73.3120) CI# 59825	Vat Green 1, Green (21CFR 73.3120) CI# 59825	Vat Blue 6, Blue (21 CFR73.3119) CI# 69825
		Vat Brown 1, Brown (21CFR 73.3117) CI# 70800	Vat Brown 1, Brown (21CFR 73.3117) CI# 70800	Not Applicable for ClearContact Lens
		Vat Blue 6, Blue (21 CFR73.3119) CI# 69825	Vat Yellow 3, Yellow (21CFR 73.3118) CI# 61725
			Vat Orange 1, Orange (21CFR 73.3112) CI# 59105
			Vat Blue 6, Blue (21 CFR73.3119) CI# 69825

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of four stylized human profiles facing right, arranged in a stacked formation, with the top profile being the most prominent and the others gradually diminishing in size.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 1998

Alden Optical Laboratories, Inc. c/o Mr. Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503

Re: K983278

Trade Name: OXYLENS TINTED PROSTHETIC (hioxifilcon B) Tinted Soft Daily Wear Contact Lens (lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: September 14, 1998 Received: September 17, 1998

Dear Mr. Dalsing :

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Martin Dalsing

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ARoey L. Rosenthal

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

Enclosure

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INDICATIONS FOR USE STATEMENT

OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Daily Wear Device Name: Contact Lens, Tinted (lathe cut).

INDICATIONS FOR USE:

The leases are available within a planned replacement program with frequency of replacement determined by the practitioner.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)



(Division Sign-Off)
Division of Ophthalmic Devices
Prescription Use (Per 21 CFR 801.109)	X
510(k) Number	K983278
	or
		Over-The-Counter Use ____

(Optional Format 1-2-96)

OXYLENS TINTED, PROSTHETIC (hionifiloon B), Soft Deily Wear Corned Lans, Ticked (latho ask)

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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.