The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic 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 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 Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of anetropia (myopia and hyperopia) and emmetropia with presbyopia in 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.

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) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are about 2.2% (<5%) in the UVB range of 280-315nm and 8.7% (<50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

AI/ML Overview

The provided document is a 510(k) premarket notification for a soft contact lens device. It describes the device, its intended use, and comparative information with predicate devices, including nonclinical and clinical study summaries.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the format of a table with specific thresholds for device performance. Instead, it states that "the physical, optical and chemical properties of the lens are within established specifications for the lenses" and that "the clinical study provided data to establish substantial equivalence with the predicate, control lens." The reported performance is primarily compared to the predicate device to demonstrate substantial equivalence, rather than meeting predefined numerical acceptance criteria for specific metrics.

However, we can infer some performance metrics from the device characteristics and the clinical study summary.

Performance Metric	Acceptance Criteria (Inferred from Predicate/Study Purpose)	Reported Device Performance
Physical/Optical/Chemical Properties	Within established specifications and comparable to predicate devices.	`Si-Hy (olifilcon B)` lens characteristics are detailed (e.g., Water Content: 47%, Oxygen Permeability (DK): 120, Refractive Index: 1.410, Light Transmittance: 94%). The document states that these properties "are within established specifications for the lenses" and are "as safe, as effective and performs as well as the predicate device" in comparison.
Material Composition	Substantially equivalent to predicate lenses (Silicone Hydrogel).	`Olifilcon B` (53% olifilcon B and 47% water) - Silicone Hydrogel. Compared to `olifilcon A` and `narafilcon A`.
Biocompatibility/Toxicity	Non-toxic and acceptable in ocular environment.	"Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment."
Visual Acuity (VA)	Mean VA similar to predicate and correctable to 0.1 (log MAR) or better.	"The mean VA for both lenses [device and predicate] was similar at each visit. The visual acuity could be corrected to 0.1 (log MAR) or better."
Slit Lamp Findings	No significant findings (Grade 3 or Grade 4) and no significant differences between groups.	"No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups."
Adverse Reactions	Not explicitly quantified as an acceptance criterion, but implies a safe profile comparable to the predicate.	Measured, but specific rates are not provided in this summary. The overall conclusion is that the device is "as safe" as the predicate.
Symptoms, Problems, Complaints	Not explicitly quantified, but taken into account for safety and effectiveness.	Measured, but specific details are not provided in this summary.
Lens Wearing Time	Not explicitly quantified, but taken into account for safety and effectiveness.	Measured, but specific details are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "At least 50 evaluable subjects were participated."
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical studies conducted for regulatory submission for a new device are almost always prospective. The manufacturer is based in Taiwan, so the study was likely conducted there or in a region convenient for the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The clinical study describes "parameters measured," implying a quantitative assessment by clinical investigators, but it does not specify the number or qualifications of experts involved in establishing a "ground truth" in the way one might for diagnostic accuracy studies (e.g., radiologist consensus). For contact lens clinical trials, "ground truth" is typically established by measurements and observations made by trained optometrists or ophthalmologists during eye examinations.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1 consensus) are common in studies where expert interpretation is subjective and needs consensus, such as pathology or imaging reads. For contact lens clinical evaluations, direct measurements and clinical findings by investigators typically serve as the primary data, and formal adjudication by multiple independent experts might not be a standard practice unless there are highly subjective or ambiguous outcomes.

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

No, an MRMC comparative effectiveness study involving AI assistance was not done. This device is a contact lens, not an AI-powered diagnostic tool. The clinical study performed was a direct comparison of the new contact lens ("Si-Hy (olifilcon B)") against a legally marketed predicate contact lens ("Vistakon (narafilcon A) Contact Lens").

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

No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device (contact lens), not an algorithm.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was established through:

Clinical Measurements and Observations: This includes objective measurements (e.g., visual acuities) and subjective observations/assessments by investigators (e.g., slit lamp findings, adverse reactions, symptoms, complaints).
Comparison to a Predicate Device: The study's primary goal was to demonstrate substantial equivalence to a legally marketed control contact lens for safety and effectiveness. The "ground truth" for what constitutes an acceptable contact lens performance is implicitly tied to that of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" typically applies to machine learning models. For a physical medical device like a contact lens, there isn't a "training set" in the computational sense. The device underwent manufacturing and quality control processes, and then was tested in nonclinical and clinical studies.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" for this device in the context of AI/machine learning. For the manufacturing and design of the contact lens, the "ground truth" for its properties and performance would have been established through extensive material science research, engineering specifications, and validated in vitro testing to meet performance standards.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three heads, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

May 26, 2016

Visco Vision Inc. % Ms. Jennifer Ting, Manager Jens Medical Consulting Ltd. 6F. No. 39, Ln 224, Jixian Rd. Luzhou Dist. 247 New Taipei City Taiwan R.O.C

Re: K160344

Trade/Device Name: Si-Hy (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens; Si-Hy (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses; Si-Hy (olifilcon B) Toric 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: April 20, 2016 Received: April 22, 2016

Dear Ms. 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 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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Kesia Alexander

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160344

Device Name

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

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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005_510(k) Summary

Preparation Date: May 6, 2016

5.1 Establishment Information:

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

5.2 Contact Person:

Company	Jens Medical Consulting Ltd.
Name	Jennifer TING
Phone No	886-2-82823192
Fax No	886-2-82867686
e-mail:	jen.medical@msa.hinet.net

5.3 Device Identification:

Proprietary Name	Si-Hy (olifilcon B) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
Common Name	Soft (hydrophilic) Contact Lenses
Classification Name	Lenses, Soft Contact, Daily Wear,(21 CFR 886.5925, Product Code LPL)Lenses, Soft Contact, Daily Wear (Disposable),(21 CFR 886.5925, Product Code MVN)
Classification	II

5.4 Legally Marketed Equivalent Device:

Indication

Vistakon (narafilcon A), K073485, Product Code: MVN

Johnson & Johnson Vision Care Inc.

Material

Visco (olifilcon A) soft contact lens, K141348, Product Code: LPL/MVN Visco Vision Inc.

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5.5 Device Description

5.6 Indication for Use:

The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens 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 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.

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.

5.7 Technological characteristic

Si-Hy SPHERICAL Soft Contact Lenses characteristics:

. Diameter Range: 13 to 15 mm
. Base Curve: 8.0 to 9.2 mm
. Center Thickness:0.08 mm for -3.00D (varies with power)
. Power: +20.00 to -20.00 D

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Si-Hy TORIC Soft Contact Lenses characteristics:

Diameter Range: 13 to 15 mm •
. Base Curve: 8.0 to 9.2 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 MULTIFOCAL Soft Contact Lenses characteristics:

Diameter Range:13 to 15 mm
Base Curve: 8.0 to 9.2 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)

$$+2.2\text{SD} \sim +2.7\text{SD (HIGH)}$$

5.8 Comparison table:

Indication for Use
Lens Design	Si-Hy (olifilcon B) soft contact lens	VISTAKON (Narafilcon A) Contact lens (K073485)	Visco (olifilcon A) soft contact lens (K141348)
Spherical	The Si-Hy Spherical SiliconeHydrogel Soft Contact Lensesare indicated as daily wearsingle use soft contact lens forthe correction of refractiveametropia (myopia andhyperopia) in phakic or aphakicpersons with non-diseased eyeswho exhibit refractiveastigmatism of 1.00D or lesswhere the astigmatism does notinterfere with visual acuity.	The VISTAKON(narafilcon A) contact Lensis indicated for daily wearsingle use only for theoptical correction ofrefractive ametropia(myopia and hyperopia) inphakic or aphakic personswith non-diseased eyes whomay have 1.00D or less ofastigmatism.	The VISCO Soft(Hydrophilic) ContactLenses is indicated fordaily wear for thecorrection of refractiveametropia (myopia andhyperopia) in phakic oraphakic persons withnon-diseased eyes whoexhibit refractiveastigmatism of 2.00D orless where the astigmatismdoes not interfere withvisual acuity.
Toric	The Si-Hy Toric SiliconeHydrogel Soft Contact Lensesare indicated as daily wear forthe correction of ametropia(myopia and hyperopia) withastigmatism in aphakic and	The VISTAKON(narafilcon A) contact Lensis indicated for daily wearsingle use only for theoptical correction of visualacuity in phakic or aphakic	NA
Multifocal	non-aphakic persons withnon-diseased eyes and whosepowers are from -20.00 to+20.00 diopters and astigmaticcorrections are from -0.75 to-2.25 diopters.The Si-Hy Multifocal SiliconeHydrogel Soft Contact lensesare indicated as daily wear forthe correction of ametropia(myopia and hyperopia) andemmetropia with presbyopia inaphakic and non-aphakicpersons with non-diseased eyesand whose powers are from-20.00 to +20.00 diopters withadd powers from +0.75 to +2.75diopters. The lenses may beworn by persons who exhibitastigmatism of 1.00 diopters orless where the astigmatism doesnot interfere with visual acuity.	persons with non-diseasedeyes that are hyperopic ormyopic and may have10.00D or less ofastigmatism.The VISTAKON(narafilcon A) contact Lensis indicated for daily wearsingle use only for theoptical correction ofdistance and near vision inpresbyopic, phakic oraphakic persons withnon-diseased eyes who mayhave 0.75D of astigmatismor less.	NA
MultifocalToric	NA	The VISTAKON(narafilcon A) contact Lensis indicated for daily wearsingle use only for theoptical correction ofdistance and near vision inpresbyopic phakic oraphakic persons withnone-diseased eyes whomay have 10.00D ofastigmatism or less.	NA
Replacement	Eye care practitioners mayprescribe the lens for daily wear(disposable use) single use. Thelenses are to be discarded uponremoval. Therefore, no cleaningor disinfecting is required. TheSi-Hy (olifilcon B) SiliconeHydrogel Soft (Hydrophilic)Contact Lens helps protectagainst transmission of harmfulUV radiation to the cornea andinto the eye.	Eye Care Professionalsshould prescribe the lensesfor daily wear single useonly (see "WearingSchedule"). The lenses areto be discarded uponremoval. Therefore, nocleaning or disinfection isrequired.	Eye care practitioners mayprescribe the lens for eithersingle-use disposablewear, or forfrequent/plannedreplacement wear, withcleaning, disinfection, andscheduled replacement.When prescribed forfrequent replacement, thelens may be disinfectedusing a chemicaldisinfection systemonly.The VISCO Soft(Hydrophilic) ContactLenses help protect againsttransmission of harmfulUV radiation to the corneaand into the eye.

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

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Similarities and differences
Item	Device	Predicate(K141348)	Predicate (K073485)
Product Name	Si-Hy (olifilcon B) SiliconeHydrogel soft contact lens	Visco (olifilcon A)soft contact lens	VISTAKON (NarafilconA) Contact lens
Manufacturer	VISCO VISION Inc.	VISCO VISION Inc.	Johnson & JohnsonVision Care Inc.
Intended Use	Myopia, Hyperopia,astigmatism, Presbyopia	Myopia, Hyeropia	Myopia, Hyperopia,astigmatism, Presbyopia
Lens Design	Spherical, toric, ormultifocal	Spherical	spheric, aspheric, toric ormultifocal
Replacement Schedule	Daily Disposable (Singleuse)	Monthly	Daily Disposable (Singleuse)
Chemical composition	Silicone Hydrogel	The same	The same
Classification	Group 1 (Nonionic, Lowwater)	The same	The same
Water Content	47 % (<50%)	47 % (<50%)	46 % (<50%),
Oxygen Permeability(DK, 35°C)	120(Fatt method)	150(Fatt method)	100(Fatt method)
Base Curve Range (mm)	8.0~9.2	8.0~9.2	7.80 ~ 10.00
Diameter (mm)	13.0~15.0	13.0~15.0	12.0~15.0
Center Thickness	Varies with design andpower (0.08 mm at -3.00D)	Varies with designand power (0.08 mmat -3.00D)	Varies with design andpower (0.085 mm at-3.00D)
Powers	-20.00D to +20.00D	-20.00D to +20.00D	The same
Refractive Index	1.410	1.410	1.410
Light Transmittance	94%	94%	> 85%
Blue handling tint	Reactive Blue19	Reactive Blue19	Reactive Blue Dye #4
Method of Manufacture	Molded	Molded	Molded

5.9 Nonclinical Tests Performed

5.9.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical,

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optical and chemical properties of the lens are within established specifications for the lenses.

5.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

5.10 Clinical Studies

A three-month clinical study was conducted to demonstrate the safety and efffectiveness of the Si-Hy (olifilcon B) silicone hydrogel soft contact lens by comparison with Vistakon (narafilcon A) Contact Lens when worn on a daily wear basis. At least 50 evaluable subjects were participated. Parameters measured include visual acuities, adverse reactions, symptom, problem and complaints, slit lamp findings, as well as lens wearing time. It was found that the mean VA for both lenses was similar at each visit. The visual acuity could be corrected to 0.1 (log MAR) or better. No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups.

The clinical study provided data to establish substantial equivalence with the predicate, control lens, Vistakon (narafilcon A) soft contact lens, JOHNSON & JOHNSON VISION CARE INC. (K073485), with respect to the safety and effectiveness.

5.11 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Si-Hy silicone hydrogel soft 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.