The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a Daily Wear Soft (hydrophilic) 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 Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.

The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated 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 -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 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 either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

Device Description

The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 41% hioxifilcon A and 59% water. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.3% (< 5%) in the UVB range of 280-315nm and14.2 % (< 50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

AI/ML Overview

This document does not contain an acceptance criteria table or a study proving the device meets specific acceptance criteria in the manner you've requested for an AI/CADe device. This document is a 510(k) premarket notification for a soft contact lens, demonstrating substantial equivalence to a predicate device rather than presenting a novel algorithm's performance against defined metrics.

Here's a breakdown of why the requested information isn't available in this document:

Device Type: The device is a "Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens," not an AI/CADe device.
Approval Pathway: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This pathway generally relies on demonstrating similar technological characteristics and performance to the predicate, rather than conducting new efficacy studies with acceptance criteria for a novel algorithm.
"No clinical data is required" statement: The document explicitly states: "The technical characteristics, formulation, manufacturing process of the subject device are equivalent to AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens (K0052290) current marketed by CearLab Pte Ltd, therefore no clinical data is required." This directly indicates that the type of study you're asking for (one proving performance against acceptance criteria) was not performed for this submission.

However, I can extract information related to the device and its comparison to a predicate, which are analogues to some of your requested points:

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

This document does not provide acceptance criteria in the typical "pass/fail" sense for a novel device feature's performance. Instead, it provides a comparison table of characteristics between the applicant's device and the predicate device to demonstrate equivalence. One could interpret the predicate device's established characteristics as the "acceptance criteria" for the new device to be considered substantially equivalent.

Item	Predicate (K052290) - "Acceptance Criteria" (Analogue)	Device - "Reported Device Performance" (Analogue)
Product Name	AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens	Largan daily wear soft contact lens
Manufacturer	ClearLab Pte Ltd.	Largan Medical Inc.
Intended Use	Myopia, Hyperopia, astigmatism	Myopia, Hyperopia, astigmatism, Presbyopia
Lens Design	spherical, toric	aspherical, toric, or multifocal
Replacement Schedule	Daily Wear	Daily Wear
Chemical composition	Hioxifilcon A	Hioxifilcon A
Classification	Group II (Nonionic, High water)	Group II (Nonionic, High water)
Water Content	57 % (>50%)	59 % (>50%)
Oxygen Permeability (DK, 35°C)	20 (Fatt method)	22 (Fatt method)
Base Curve Range (mm)	8.0 ~ 9.2	8.0~9.0
Diameter (mm)	13.0~15.0	13.0~15.0
Center Thickness	Varies with design and power (0.08 mm at -3.00D)	Varies with design and power (0.102 mm at -1.00D)
Powers	-20.00D to +20.00D	-10.00D to +3.00D
Refractive Index	1.4058	1.403
Light Transmittance	>95%	90%
Blue handling tint	Reactive Blue 19	Reactive Blue 247
Method of Manufacture	Cast Molded	Cast Molded

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "no clinical data is required." Therefore, there is no test set, sample size, or data provenance information of this nature. Non-clinical physiochemical and toxicology studies were performed, but these are for material properties, not a performance evaluation in a test set as you imply for an AI/CADe device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set.

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

Not applicable. No clinical test set.

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. No MRMC study was done.

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

Not applicable. This is not an algorithm/AI device.

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

For the non-clinical tests: The "ground truth" for physiochemical studies would be established specifications and reference standards (e.g., ISO 18369). For toxicology, it would be standard biocompatibility testing protocols, showing the lenses are "non-toxic and biocompatible."

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in this context.

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

Not applicable. No training set.

In summary, this document is a regulatory submission for a medical device (contact lens) through the 510(k) pathway, which focuses on demonstrating substantial equivalence. The specific types of acceptance criteria and studies you've requested are characteristic of AI/CADe devices or PMA submissions for novel devices, neither of which applies here.

Summary

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Public Health Service

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

September 18, 2017

Largan Medical Co. Ltd. % Jennifer Ting RA Manager Jens Medical Consulting Ltd 6F, No 39, Ln 224, Luzhou Dist., New Taipei City, TW 247 Taiwan R.O.C.

Re: K170286

Trade/Device Name: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens For Presbyopia Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 12, 2017 Received: August 24, 2017

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.

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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 (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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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.

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) K170286

Device Name

Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact Lens Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact lens for ASTIGMATISM Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact lens for PRESBYOPIA

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 K170286

Preparation Date: August 14, 2017

1.1 Establishment Information:

Name	Largan Medical Co. Ltd.
Owner	Adam Lin
Title	CEO
Address	2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung,40850, Taiwan
Phone No.	886-4-3600-0203
Fax No.	886-4-3601-0203
E-mail	info@larganmed.com.tw

1.2 Contact Person:

Phone No.	886-4-3600-0203
Fax No.	886-4-3601-0203
Contact Name	Amy Tien
E-mail	amytien@larganmed.com.tw

1.3 Device Identification:

Proprietary Name	Largan (hioxifilcon A) Daily Wear 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
Regulation Number	CRF 886.5925
Review Panel	Ophthalmic
Product Code	LPL/MVN

1.4 Legally Marketed Equivalent Device:

Predicate Device Name	AQUASOFT ALL-DAY & ALL-DAY T(hioxifilcon A) Daily Wear Contact Lens.
Manufacturer	ClearLab Pte Ltd.
510(k) Number	K052290
Product Code	LPL

1.5 Device Description

1.6 Indication for Use:

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The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a Daily Wear Soft (hydrophilic) 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 Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated 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 -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.

The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated 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 -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 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

Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens characteristics:

Diameter Range: 13.0 to 15.0 mm ●
. Base Curve:8.0 to 9.0 mm
Center Thickness:0.102 mm for -1.00D (varies with power)
Power: +3.00 to -10.00 D

Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism characteristics:

. Diameter Range: 13.0 to 15.0 mm
Base Curve:8.0 to 9.0 mm
Center Thickness:0.102 mm for -1.00D (varies with power) ●
. Power: +3.00 to -10.00 D
Cylinder: -0.25D ~ -5.00 D .
. Axis: 10° to 180° (in 10° increments)

Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia characteristics:

. Diameter Range: 13.0 to 15.0 mm
. Base Curve:8.0 to 9.0 mm
. Center Thickness:0.102 mm for -1.00D (varies with power)
Power: +3.00 to -10.00 D
Additional Powers: +0.25D ~ +3.50D

1.8 Comparison table:

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

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Similarities and differences
Item	Device	Predicate (K052290)
Product Name	Largan daily wear soft contact lens	AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens
Manufacturer	Largan Medical Inc.	ClearLab Pte Ltd.
Intended Use	Myopia, Hyperopia, astigmatism, Presbyopia	Myopia, Hyperopia, astigmatism
Lens Design	aspherical, toric, or multifocal	spherical, toric
Replacement Schedule	Daily Wear	The same
Chemical composition	Hioxifilcon A	The same
Classification	Group II (Nonionic, High water)	The same
Water Content	59 % (>50%),	57 % (>50%),
Oxygen Permeability (DK, 35°C)	22 (Fatt method)	20 (Fatt method)
Base Curve Range (mm)	8.0~9.0	8.0 ~ 9.2
Diameter (mm)	13.0~15.0	13.0~15.0
Center Thickness	Varies with design and power (0.102 mm at -1.00D)	Varies with design and power (0.08 mm at -3.00D)
Powers	-10.00D to +3.00D	-20.00D to +20.00D
Refractive Index	1.403	1.4058
Light Transmittance	90%	>95%
Blue handling tint	Reactive Blue 247	Reactive Blue 19
Method of Manufacture	Cast Molded	Cast Molded

1.9 Nonclinical Tests Performed

Physiochemical studies were conducted according to ISO 18369 First edition 1.9.1 2006-08-15, 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 technical characteristics, formulation, manufacturing process of the subject device are equivalent to AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens (K0052290) current marketed by CearLab Pte Ltd, therefore no clinical data is required.

1.11 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Largan (hioxifilcon A) Daily Wear 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.