The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may also be indicated to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

Device Description

The Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (< 5%) in the UVB range of 280-315nm and 8.7% ( < 50%) in the UVA range of 316-380nm. All colored additives used including ultraviolet absorbing additive (benzophenone based) are listed in 21CFR 73 subpart Dand 74 sbupart D.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically a soft contact lens. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a new clinical trial with specific acceptance criteria.

Therefore, the information requested in your prompt (acceptance criteria, study design for proving acceptance, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training set details) is not applicable in this context as this submission is for a contact lens which does not utilize AI. The FDA letter and the 510(k) summary explicitly state that clinical data is not required because the new device uses the same lens material as a previously cleared device and the same color additives as another previously cleared device.

The review primarily focuses on:

Substantial Equivalence: Demonstrating that the new device has the same intended use, similar technological characteristics, and is as safe and effective as a legally marketed predicate device.
Nonclinical Testing: Performance of physicochemical studies (e.g., according to ISO 18369) and toxicology studies to ensure the material and lens properties meet established specifications and are biocompatible.

Here's how to interpret the provided information in the context of your request, highlighting why many aspects are not present:

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

Acceptance Criteria: Not overtly stated as distinct "acceptance criteria" in the sense of a clinical trial endpoint. Instead, the "acceptance" is suitability for substantial equivalence, based on demonstrating similar properties and performance to the predicate devices.
- Physicochemical Properties: The reported performance is that the "physical, optical and chemical properties of the lens are within established specifications for the lenses" (Section 1.9.1).
- Toxicology: "toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment" (Section 1.9.2).
Device Performance: The comparison table (Section 1.8) shows various characteristics of the new device and the predicate devices. The "performance" is implicitly demonstrated by these characteristics being similar or equivalent to the predicates. For example:
- Water Content: 47% (new device) vs. 47% (predicate K160344) and 42% (predicate K162317)
- Oxygen Permeability (DK, 35°C): 120 (new device) vs. 120 (predicate K160344) and 10.89 (predicate K162317)
- Light Transmittance: 94% (new device) vs. 94% (predicate K160344) and 97% (predicate K162317)

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

Not Applicable. No human clinical test set was used given the nature of the submission. The "test sets" would be the batches of lenses manufactured for physicochemical and toxicology testing. No information on the number of lenses tested is provided.

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

Not Applicable. No human-interpreted "ground truth" was established. The "ground truth" for the non-clinical tests is based on objective measurements and established scientific methods (e.g., ISO standards, toxicology protocols).

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

Not Applicable. No human adjudication was involved.

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 device, and no MRMC study was conducted.

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

Not Applicable. This is not an algorithm.

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

For the non-clinical tests (physicochemical, toxicology), the "ground truth" is derived from objective laboratory measurements and adherence to established international standards (e.g., ISO 18369) and biocompatibility testing protocols.

8. The sample size for the training set:

Not Applicable. There is no training set for an AI/ML model for this device.

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

Not Applicable. There is no training set for an AI/ML model for this device.

In summary, the provided document is a regulatory submission for a contact lens, not an AI/ML-powered medical device. Therefore, the detailed criteria for AI/ML model validation are not present and not relevant to this specific product's clearance. The "proof" of meeting "acceptance criteria" here is the demonstration of substantial equivalence to predicate devices through shared material, similar intended use, and satisfactory non-clinical laboratory testing.

Summary

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April 19, 2018

Visco Vision, Inc. Jennifer Ting RA Manager Jens Medical Consulting Ltd. 6F, No. 39, Jixian Rd., Luzhou Dist. New Taipei City, TW 247

Re: K180322

Trade/Device Name: Si-Hy (olifilcon B) color silicone hydrogel soft contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 20, 2018 Received: February 21, 2018

Dear Jennifer Ting:

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

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K180322

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); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Denise L. Hampton -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) K180322

Device Name

Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (hydrophilic) Contact Lens

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Preparation Date: April 11, 2018

1.1 Establishment Information:

Name	Visco Vision Inc.
Address	No. 1, Xingye St., Guishan Dist., Taoyuan City 33341 Taiwan
Contact	Ted TT Huang
Phone No.	886-3-3596868
Fax No.	886-3-3490202

1.2 Contact Person:

Name	Evan Huang
Phone No.	886-3-3596868
Fax No.	886-3-3490202
e-mail:	evan.huang@viscovision.com.tw

1.3 Device Identification:

Proprietary Name	Si-Hy (olifilcon B) Color Silicone Hydrogel Soft ContactLens
Common Name	Soft (hydrophilic) Contact Lenses
Classification Name	Soft (hydrophilic) contact lens. (21 CFR 886.5925)
Product Codes	LPL, MVN
Classification	II

1.4 Legally Marketed Equivalent Device:

Intended use

Predicate Device Name	Saview-Color Aqua 42 UV (hefilcon A)soft (hydrophilic) contact lens
Manufacturer	St. Shine Optical Co., Ltd.
510(k) Number	K162317
Product Codes	LPL, MVN
Lens material
Predicate Device Name	Si-Hy (olifilcon B) silicone hydrogel soft contact len
Manufacturer	Visco Vision Inc.
510(k) Number	K160344
Product Codes	LPL, MVN

1.5 Device Description

The Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses

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are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (< 5%) in the UVB range of 280-315nm and 8.7% ( < 50%) in the UVA range of 316-380nm. All colored additives used including ultraviolet absorbing additive (benzophenone based) are listed in 21CFR 73 subpart Dand 74 sbupart D.

1.6 Indication for Use:

The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Si-Hy (olifilcon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

1.7 Technological characteristic

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Si-Hy Color SPHERICAL Soft Contact Lenses characteristics:

Diameter Range: 13.00 to 15.00 mm •
. Base Curve:8.00 to 9.20 mm
Center Thickness:0.08 mm for -3.00D (varies with power)
. Power:+20.00 to -20.00 D

Si-Hy Color TORIC Soft Contact Lenses characteristics:

. Diameter Range: 13.00 to 15.00 mm
. Base Curve:8.00 to 9.20 mm
Center Thickness:0.08 mm for -3.00D (varies with power) .
Power:+20.00 to -20.00 D •
. Cylinder: -0.75D ~ -2.25D
Axis: 10° to 180° (in 10° increments) .

Si-Hy Color MULTIFOCAL Soft Contact Lenses characteristics:

Diameter Range: 13.00 to 15.00 mm
Base Curve:8.00 to 9.20 mm .
. Center Thickness:0.08 mm for -3.00D (varies with power)
Power:+20.00 to -20.00 D •
Additional Powers: +0.75D ~ +1.25D (LOW) •
- +1.50D ~ +2.00D (MID)
- +2.25D ~ +2.75D (HIGH)

1.8 Comparison table:

The characteristic comparison to predicate device is summarized in the following table.

Similarities and differences
Item	Device	Predicate(K160344)	Predicate (K162317)
Product Name	Si-Hy (olifilcon B)Color Silicone Hydrogelsoft contact lens	Si-Hy (olifilcon B) SiliconeHydrogel softcontact lens	Saview-Color Aqua 42UV (hefilcon A) soft(hydrophilic) contact lens
Manufacturer	Visco Vision Inc.	Visco Vision Inc.	St. Shine Optical Co.,ltd
Intended Use	Myopia, Hyperopia,astigmatism, Presbyopia	The same	The same

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Lens Design
Lens Design	Spherical, toric, or multifocal	The same	The same
Replacement Schedule	Daily Disposable (Single use)	The same	The same
Chemical composition	olifilcon B	olifilcon B	Hefilcon A
Classification	Group 5C (Nonionic, Water < 50 wt %)	The same	The same
Water Content	47 % (<50%),	The same	42%
Oxygen Permeability (DK, 35°C)	120 (Fatt method)	The same	10.89
Base Curve Range (mm)	8.0~9.2	The same	NA
Diameter (mm)	13.0~15.0	The same	NA
Center Thickness	Varies with design and power (0.08 mm at - 3.00D)	The same	NA
Powers	-20.00D to +20.00D	The same	-20.00D -+12.00D
Refractive Index	1.410	The same	1.435
Light Transmittance	94%	The same	97%
Visibility Tint	NA	Reactive Blue19	NA
Color additives for print	Iron oxide, [Phthalocyaninato (2-)] copper Titanium dioxide, Phthalocyanine green, Carbazole violet	NA	iron oxide Titanium dioxide [Phthalocyaninato (2-)] copper Phythalocyanine green Carbazole violet
Method of Manufacture	Molded	Molded	Moulded

1.9 Nonclinical Tests Performed

1.9.1 Physiochemical studies were conducted according to ISO 18369, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

1.10 Clinical Studies

The lens material is the same as the Si-Hy (olifilcon B) silicone hydrogel soft (hydrophilic) contact lens currently available (K141348). The color additives used is the same as Saview-Color Aqua 42 UV (hefilcon A) soft (hydrophilic) contact

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lens currently available (K162317). Therefore, the clinical data is not required.

1.11 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Si-Hy (olicofilcon B) color silicone hydrogel soft (hydrophilic) contact lens'' is as safe, as effective and performs as well as the predicate device.

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.