The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Device Description

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.

AI/ML Overview

The provided document is a 510(k) premarket notification for a contact lens, the "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies typical for novel medical devices or AI algorithms. As such, the information you're requesting regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and training sets is not applicable to this document.

The "study that proves the device meets the acceptance criteria" in this context refers to a series of preclinical (non-clinical) tests and a comparison to a predicate device, rather than human clinical trials or AI performance evaluations.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this contact lens submission, the "acceptance criteria" are not framed as specific performance thresholds for an AI algorithm's metrics (like sensitivity, specificity, or AUC). Instead, they are demonstrated through equivalence to a legally marketed predicate device and through non-clinical testing that proves the device meets established standards for contact lens safety and function.

The table below summarizes the key comparative data provided for the subject device and its predicate, which implicitly defines the "acceptance criteria" through equivalence.

Item	Predicate Device (K020927) BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens	Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (Reported Performance)	Acceptance Criteria (Implicitly, Equivalence to Predicate)
Regulatory Number	886.5925	886.5925	Same as predicate
Classification	II	II	Same as predicate
Intended Use	Daily wear for 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.	Daily wear for correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less.	Similar to predicate, with some indication differences that do not raise new safety/effectiveness concerns.
Prescription Use	Yes	Yes	Yes
Material	polymacon	polymacon	polymacon
Manufacturing Method	Cast Molded	Cast Molded	Cast Molded
Water Content	38%	38%	38%
Powers	$\pm 20.00D$	$-0.50D \sim -12.00 D$	Demonstrated range is acceptable and supported by material properties.
Light Transmittance	$\ge 96%$	$95% \pm 5%$	Comparable to predicate.
UV-A	- (Not specified in table)	< 50% (transmittance)	Meets UV blocking standards for Polymacon lenses.
UV-B	- (Not specified in table)	< 5% (transmittance)	Meets UV blocking standards for Polymacon lenses.
Refractive Index	1.4375	1.440 $\pm$ 0.005	Comparable to predicate.
Base Curve	7.5mm ~ 9.5mm	8.6 $\pm$ 0.2mm	Within acceptable range and comparable to predicate.
Diameter	13.5mm ~ 15.5mm	14.0 $\pm$ 0.2mm	Within acceptable range and comparable to predicate.
Tint	Reactive Blue Dye 246	C.I. Reactive Blue #4	Appropriate for visibility, and color additives are deemed safe.

Summary of Non-Clinical Test Results (Meeting Implicit Acceptance Criteria):

The submission states that a series of preclinical tests were performed, and "The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is equivalent to the BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927).". The tested areas include:

Toxicity:
- Acute Systemic Injection Study: Meets requirements, considered non-toxic.
- White Rabbit Ocular Irritation Test: No ocular irritation.
- Cytotoxicity Test: Meets ISO 10993-5 (non-cytotoxic).
Extractables
Finished Lens Parameters
Light Transmittance
Refractive Index
Water Content
pH and Osmolality
Specific Gravity
Physical Compatibility
Oxygen Permeability
Mechanical Comparative Testing
Shelf-life test

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

Sample Size: Not explicitly stated numerically for each non-clinical test, but implied to be sufficient to meet regulatory standards for each specific test (e.g., number of rabbits for ocular irritation, samples for physical/chemical characterization). These are laboratory-based tests, not human clinical trials or large image datasets.
Data Provenance: The tests were conducted by the manufacturer, Yung Sheng Optical Co., Ltd., in Taiwan. There is no mention of retrospective or prospective data in the context of clinical studies, as none were performed.

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

Not applicable. "Ground truth" in the AI sense (e.g., expert annotation of medical images) does not apply here. The "truth" for these tests is established by standardized laboratory methods and regulatory guidelines (e.g., ISO standards, FDA recommendations).

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

Not applicable. There is no expert adjudication process over "test sets" as understood in AI/ML performance evaluation. Laboratory test results are interpreted against predefined specifications.

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 a contact lens submission, not an AI-powered diagnostic device. No MRMC study was performed.

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

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

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

The "ground truth" for this device's safety and performance is based on established scientific and engineering principles, standardized laboratory testing methodologies (e.g., ISO, FDA guidance documents), and demonstrated equivalence to a legally marketed predicate device. It's primarily material characterization, biocompatibility testing, and physical performance metrics rather than clinical outcomes or expert consensus.

8. The sample size for the training set:

Not applicable. This is not an AI/Machine Learning device. There is no "training set."

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

Not applicable. There is no "training set" or AI model.

Summary

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K182854

DEC 2 3 2013

Yung Sheng Optical Co., Ltd.
510(k) notification

Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

510(k) Summary

1. Type of Submission:	Traditional
------------------------	-------------

Submitter:		Yung Sheng Optical Co., Ltd.
	Address:	3F-1, No.6, Jhongke Road, Daya District, Taichung City 42881
		Taiwan
	Manufacturing facility:	No.8, Keya 2nd Road, Daya District, Taichung City 42881,
		Taiwan
	Phone:	(04) 25658384 #156 、191
	Fax:	(04) 25658387
	Contact:	Wen-Han Chen / Mavis Kao
	Date prepared:	December 17th, 2013

3. Identification of the Device

Proprietary/Trade name:	Eye Secret 38 UV Aspheric (polymacon) Soft
	(hydrophilic) Contact Lens for Daily Wear
Common Name:	Contact Lens
Classification Name:	Lenses, Soft Contact, Daily Wear
Device Classification:	II
Regulation Number:	886.5925
Panel:	Ophthalmic
Product Code:	LPL for Lenses, Soft Contact, Daily Wear
	MVN for Lens, Contact, (Disposable)

4. ldentification of the Predicate Device

Predicate Device Name:	BAUSCH & LOMB Soflens MultiFocal (polymacon) VisibilityTinted Contact Lens
Manufacturer:	BAUSCH & LOMB
510(k) Number or Clearance Information:	K020927

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Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

5. Intended Use and Indications for Use of the subject device

6. Device Description

7. Summary of Clinical Study

Polymacon lenses have been used widely. Their safety and effectiveness have been well documented and cleared by FDA. BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927) submitted by BAUSCH & LOMB is an example.

Clinical study for Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.

8. Non-dinical Testing

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear. The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is equivalent to the

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Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, February 27, 1997:

Toxicity .
- 1. Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
- 1. White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
- 1. Cytotoxicity Test: The test article meets the requirements of ISO 10993-5.
Extractables .
Finished Lens Parameters
Light Transmittance +
. Refractive Index
Water Content .
pH and Osmolality .
. Specific Gravity
. Physical Compatibility
Oxygen permeability
Mechanical Comparative Testing
. Shelf-life test

The results of the non-clinical testing demonstrated that the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device.

ਰੋਂ Substantial Equivalence Determination .

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear submitted in this 510(k) file is substantially equivalent in intended use, technology/principles of operation, materials and performance to the cleared BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens which is the subject of K020927. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

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Eye Secret 38 UV Aspheric (polymacon) Soft

Item	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilic)Contact Lens for Daily Wear	Predicate Device (K020927)BAUSCH & LOMB Soflens MultiFocal(polymacon) Visibility Tinted ContactLens
RegulatoryNumber	886.5925	886.5925
Classification	II	II
Intended Use	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilic)Contact Lens for Daily Wear isindicated for daily wear for thecorrection of refractive ametropia(myopia) in aphakic and not-aphakicpersons with non-diseased eyes. Thelenses may be worn by person whoexhibit astigmatism of 2.00 dioptersor less that does not interfere withvisual acuity.	BAUSCH & LOMB Soflens MultiFocal(polymacon) Visibility Tinted ContactLens is indicated for daily wear forthe correction of the refractiveametropia (myopia, hyperopia, andastigmatism) and presbyopia inaphakic and/or not-aphakic personswith non-diseased eyes, exhibitingastigmatism of 2.00 diopters or less,that does not interfere with visualacuity.
PrescriptionUse	Yes	Yes
Material	polymacon	polymacon
ManufacturingMethod	Cast Molded	Cast Molded
Water Content	38%	38%
Powers	$-0.50D ~ -12.00 D$	$\pm 20.00D$
LightTransmittance	95% ± 5%	≥ 96%
UV-A	< 50%	-
UV-B	< 5%	-
RefractiveIndex	1.440 ± 0.005	1.4375
Base Curve	8.6 ± 0.2mm	7.5mm ~ 9.5mm
Diameter	14.0 ± 0.2mm	13.5mm ~ 15.5mm
Tint	C.I. Reactive Blue #4	Reactive Blue Dye 246

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10. Condusion

After analyzing bench tests, safety testing data, it can be concluded that Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

December 23, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Yu-Ming Hsich Factory Director 3F-1. No. 6. Jhongke Road Daya District Taichung City 42881 Taiwan

Re: K132854/S001

Trade Name: Eye Secret 38 UV (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Code: LPL Dated: November 22, 2013 Received: December 2, 2013

Dear Mr. Hsieh:

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. 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.

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Page 2 - Mr. Yu-Ming Hsieh

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ K132854

Device Name: _ Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use:

The Eye Secret 38 UV Apsheric (polymacon) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

x___________________________________________________________________________________________________________________________________________________________________________ Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR :

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josep
2013.16.05'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number__K132854_

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.