The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.

Device Description

The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, 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. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (isofilcon) 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 and appear somewhat warped; 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 36% water by weight.

AI/ML Overview

This document doesn't contain a study that demonstrates the device meets acceptance criteria. Instead, it's a 510(k) summary for a medical device (AL-47 Toric contact lens) seeking FDA clearance based on substantial equivalence to previously marketed predicate devices, not on new clinical performance data.

Therefore, most of the information requested about acceptance criteria and a detailed study (like sample sizes, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

However, I can extract the information that is available:

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

Since this is a substantial equivalence submission, "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is presented as equivalence to these predicate characteristics.

Characteristic	Implied Acceptance Criteria (Predicate Device Range/Value)	AL-47 Toric Performance	Meets Criteria?
Production Method	Lathe-Cut	Lathe-Cut	Yes
Lens Function	Refractive medium compensating for refractive error, including astigmatism	Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism)	Yes
Material	Hydrophilic Polymer	Hydrophilic Polymer	Yes
Water Content	38%/45%	36%	Implied Yes (similar enough for equivalence)
Polymer Content	62%/55%	65%	Implied Yes (similar enough for equivalence)
Polymer	polymacon/hefilcon B	isofilcon	Implied Yes (different polymer but deemed equivalent overall)
DK Value	18.8/13.0	3.7	Implied Yes (different DK but deemed equivalent overall)
Refractive Index	1.43 (hydrated)	1.43 (hydrated)	Yes
Specific Gravity	1.180 (hydrated)	1.19 (hydrated)	Implied Yes (similar enough for equivalence)
FDA polymer group number	Group # 1 (Low water <50% water, nonionic)	Group # 1 (Low water <50% water, nonionic)	Yes
Light Transmission	greater than 93% T	greater than 93% T	Yes
Physical Properties	(Implied to be acceptable for contact lenses, based on predicate)	Refractive Index: 1.435 (hydrated) Light Transmission: greater than 93% T Water Content: 35.5 % by weight Specific Gravity: 1.19 (hydrated) Oxygen Permeability: 3.7 X 1011 (cm /sec) (ml Oxml x mm Hg @ 21 C)	Yes

Regarding the study that proves the device meets acceptance criteria:

The document does not describe a new clinical study to establish performance against acceptance criteria for the AL-47 Toric lens. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" is effectively a comparison of characteristics and intended use.

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

Not applicable. No new test set data from human subjects is presented or analyzed to prove performance against specific clinical acceptance criteria. The submission relies on the established safety and effectiveness of predicate devices.
The safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is stated to be "equivalent to AL-47 (spherical), PMA # P820078", which refers to prior data for a non-toric version of the lens. No specific sample sizes for this prior data are detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set requiring expert ground truth establishment is described.

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

Not applicable. No test set requiring adjudication is 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 device is a contact lens, not an AI diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This device is a contact lens, not an algorithm.

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

Not applicable. No new ground truth for performance is established for this submission. The "ground truth" for the device's acceptable safety and effectiveness is implicitly derived from the long-standing use and FDA clearance of the predicate devices and the original AL-47 spherical lens.

8. The sample size for the training set:

Not applicable. This device's clearance is based on substantial equivalence to existing devices, not a machine learning model's training.

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

Not applicable. No training set for a machine learning model is involved.

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.

K973847 The assigned 510(k) number is:

Applicant information:

Date Prepared:	October 10, 1997
Name:	Alden Optical Laboratories
Address	13295 Broadway
	Alden, New York 14004
Contact Person:	Charles H. Creighton
Phone Number:	800.253.3669
Consultant:	Martin Dalsing
Phone Number:	970.243.5490

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Trade Name:	AL-47 Toric
Classification Name:	Lenses, Soft Contact, Daily Wear

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Equivalent Devices:

The AL-47 Toric is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include Optima Toric manufactured by Bausch & Lamb Co, the Soft 38 Toric manufactured by California optics and the AL-47 (spherical) manufactured by Alden Optical.

Device Description:

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (isofilcon) 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 and appear somewhat warped; 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 36% water by weight. The physical properties of the lens are:

Refractive Index Light Transmission: Water Content Specific Gravity Oxygen Permeability

1.435 (hydrated) greater than 93% T 35.5 % by weight 1.19 (hydrated) 3.7 X 1011 (cm /sec) (ml Oxml x mm Hg @ 21 C), (as measured by Schema Versatae)

Intended Use:

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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 AL-47 (spherical), PMA # P820078. 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 raise different questions of safety and effectiveness than the predicate devices identified above.

The following matrix illustrates that the production method, lens function and material of the AL-47 Toric contact lens is substantially equivalent to the predicate devices. In addition, the water content, polymer, DK value, refractive index, specific gravity, and light transmission are as well substantially equivalent.

	Characteristic	AL-47 Toric	PREDICATEDEVICE(S)
1.)	PRODUCTIONMETHOD	Lathe-Cut	SAME
2.)	LENS FUNCTION	Refractive medium that focuses light raysfrom near and distant objects on the retina,while compensating for refractive error,including (astigmatism)	SAME
3.)	MATERIAL	Hydrophilic Polymer	SAME
a.	Water Content	36%	38%/45%
b.	Polymer Content	65%	62%/55%
c.	Polymer	isofilcon	polymacon/hefilcon B
d.	DK Value	3.7	18.8/13.0
e.	Refractive Index	1.43 (hydrated)	1.43 (hydrated)
f.	Specific Gravity	1.19 (hydrated)	1.180 (hydrated)
g.	FDA polymer groupnumber	Group # 1Low water <50% water, nonionic	Same
h.	Light Transmission	greater than 93% T	SAME

Substantial Equivalence Matrix

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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 its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 8 1997

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

Re: K973847

Trade Name: AL-47 (isofilcon) Toric Hydrophilic Contact Lens for Daily Wear (lathecut, clear) Regulatory Class: II Product Code: 86 LPL Dated: October 8, 1997 Received: October 8, 1997

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,

A. Ralph 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

Device Name: AL-47 Toric (isofilcon) Soft (Toric) Daily Wear Contact Lens

INDICATIONS FOR USE:

The AL-47 Toric (isofilcon) Soft Contact Lens 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 possesses refractive astigmatism not exceeding 10 Diopters.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

. . .

(Optional Format 1-2-96)

Kavin Wabaton
Division Sign Off

(Division Sign-Off) Division of Ophthalmic Devices £973847 510(k) Number _

AL-47 Toric (isofilcon) Soft (Toric) Daily Wear 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.