The ALDEN CLASSIC TINTED (polymacon) 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 ALDEN CLASSIC TINTED (polymacon) Toric Soft Contact Lenses 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.

Device Description

The ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, 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 Blue tint (transparent/enhancing), 7,16-Dichloro-6, 15-dihydro-5, and 9,14,18anthrazinetetrone is added to the lens.

In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) 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.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (soft contact lenses) and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the way envisioned by the prompt.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document.

Here's an attempt to structure the information based on the prompt's request, noting where information is absent:

Acceptance Criteria and Device Performance Study Summary

This submission for the ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted relies on demonstrating substantial equivalence to predicate devices rather than a de novo performance study against specific acceptance criteria. The "acceptance criteria" in this context are interpreted as the critical physical and material properties that allow the device to be considered substantially equivalent to already approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied by the characteristics of the predicate device, which the new device must match to demonstrate substantial equivalence.

Characteristic	Implied Acceptance Criterion (from Predicate Device)	Reported Device Performance (ALDEN CLASSIC TINTED)
Production Method	Lathe-Cut	Lathe-Cut
Lens Function	Refractive medium focusing light rays, compensating for refractive error (including astigmatism)	Refractive medium focusing light rays, compensating for refractive error (including astigmatism)
Material	Hydrophilic Polymer	Hydrophilic Polymer
Water Content	38%	38%
Polymer Content	62%	62%
Polymer	Polymacon	Polymacon
DK Value (Oxygen Permeability)	9 x 10⁻¹¹ Fatt Units (at 35°C)	9 x 10⁻¹¹ Fatt Units (at 35°C)
Refractive Index	1.43 (hydrated)	1.43 (hydrated)
Specific Gravity	1.180 (hydrated)	1.180 (hydrated)
Light Transmission	Greater than 70% T	Greater than 70% T
Dye Color	Blue visibility tint (specifically phthalocyanato (2) (copper) for Benz-38)	Blue (7,16-Dichloro-6,15-dihydro-5,9,14,18anthrazinetetrone / 21CDR 73,3119 / CI # 69825)

Note on Dye Color: The device differs in the specific dye color used compared to the predicate, but this is acknowledged and presumably deemed non-critical for substantial equivalence in safety and effectiveness regarding the overall functionality of a tinted contact lens.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not applicable. The submission relies on comparing material properties and manufacturing processes, not a clinical test set with patient data for performance evaluation.
Data Provenance: Not applicable.

3. Number of Experts for Ground Truth and Qualifications

Not applicable. Ground truth, in the sense of expert consensus on clinical outcomes, is not established for this type of submission. The 'ground truth' for comparison is the established properties of the predicate devices.

4. Adjudication Method for Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic imaging device involving interpretation by multiple readers.

6. Standalone Performance Study

Not applicable in the typical sense of algorithm-only performance. The "performance" is demonstrated through the equivalence of physical and chemical properties to already approved devices.

7. Type of Ground Truth Used

The "ground truth" for this substantial equivalence argument is derived from the known and approved specifications and performance characteristics of the predicate devices (Metro Tint and BENZ-38) and established scientific measurements of material properties.

8. Sample Size for Training Set

Not applicable. There is no AI/machine learning component requiring a training set.

9. How Ground Truth for Training Set Was Established

Not applicable.

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.

February 9, 1998

13295 Broadway

800.253.3669

623 Glacier

970.243.5490

970.243.5501

APR - 7 1998

The assigned 510(k) number is:

K980554

Alden Optical Laboratories

Alden, New York 14004

Mr. Charles H. Creighton

Med-Vice Consulting, Inc.

Grand Junction, CO 81503

Mr. Martin Dalsing

Applicant information:

Date Prepared:

Name: Address

Contact Person: Phone Number:

US Consultant:

Phone Number: Fax Number:

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Trade Name:	ALDEN CLASSIC TINTED (polymacon) Soft (Spherical& Toric) Daily Wear Contact Lens, Tinted(Transparent/Enhancing)
Classification Name:	Lenses, Soft Contact, Daily Wear

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Equivalent Devices:

The ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include Metro Tint manufactured by Metro Optics and the BENZ-38 manufactured by Benz Research and Development.

Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:

Refractive Index	1.52 (dry) 1.43 (hydrated)
Light Transmission:	greater than 70% T
Water Content	38 %
Specific Gravity	1.28 (dry) 1.18 (hydrated)
Oxygen Permeability	9 X 10-11 Fatt Units (cm2/sec)(ml O2/ml x mm Hg @ 35° C), (revised Fatt method)

Intended Use:

The ALDEN CLASSIC TINTED (polymacon) Spherical Soft Contact Lenses 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. 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 ALDEN CLASSIC TINTED (polymacon) Toric Soft Contact Lenses for daily waar 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.

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Substantial Equivalence:

The device 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 device is equivalent to the BENZ-38 (polymacon), 510(k) #K961103. Being similar with respect to indications for use, 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 roise different questions of i safety and effectiveness than the predicate devices identified above.

The following matrix illustrates that the production method, lens function and material of the ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing) are substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device.

	Characteristic	ALDEN CLASSIC TINTED	PREDICATEDEVICE
1.)	PRODUCTIONMETHOD	Lathe-Cur	SAME
2.)	LENS FUNCTION	Refractive medium that focuses lightrays from near and distant objects onthe retina, while compensating forrefractive error, including(astigmatism)	SAME
3.)	MATERIAL	Hydrophilic Polymer	SAME
a.	Water Content	38%	SAME
b.	Polymer Content	62%	SAME
c.	Polymer	polymacon	SAME
d.	DK Value	9	SAME
e.	Refractive Index	1.43 (hydrated)	SAME
f.	Specific Gravity	1.180 (hydrated)	SAME
g.	Light Transmission	greater than 70% T	SAME
h.	Dye Color	Blue (21CDR 73,3119)CJ # 69825	SAME

Substantial Equivalence Matrix

The Dye Color in the SE predicate device "Benz-38" is that of phthalocyanato (2) (copper) being a blue visibility tint and not the Vat blue 6 CI# 69825.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 1998

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

Re: K980554

Trade Name: Alden Classic Tinted (polymacon) Hydrophilic Contact Lens for Daily Wear (Lathe-cut, enhancement tint) Regulatory Class: II Product Code: 86 LPL Dated: February 9, 1998 Received: February 13, 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 at (301) 443-6597.

Sincerely yours,

A. Ralph Rosenthal, MD

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

Device Name: ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing)

INDICATIONS FOR USE:

(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
510(k) Number	K980554
	Karen Warbenton
	or
	(Optional Format 1-2-96)

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use	__________
----------------------	------------

ALDEN CLASSIC TINTED (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing) ...14

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.