The Etafilcon with Tangible Coating (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The Etafilcon with Tangible Coating (etafilcon A) TORIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism.

The Etafilcon with Tangible Coating (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal.

Device Description

The Etafilcon with Tangible Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is available in an aspheric design and manufactured using the cast-molding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are crosslinked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization.

The Etafilcon with Tangible™ Coating (etafficon A) Soft (Hydrophilic) Daily Wear Contact Lenses are available in a light blue tint ([Phthalocyaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 mm), and less than 30% in the UVA range (316 to 380nm).

The Etafilcon with Tangible "M Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is treated to incorporate Tangible TM Coating Technology-which is a thin biocompatible polymer that is covalently bonded to the surface of the contact lens.

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 (etafilcon A) soft hydrophilic contact lens has an aspheric 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 lenses are supplied sterile in blister packages containing a buffered saline solution. Package labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

AI/ML Overview

This document describes the premarket notification (510(k)) for the "Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens." It asserts substantial equivalence to predicate devices and describes the non-clinical and previous clinical performance testing. However, it does not contain specific acceptance criteria with reported device performance in a table format for a diagnostic device. Since this is an approval for a contact lens, the nature of the "acceptance criteria" and "device performance" differ significantly from what would be expected for a diagnostic AI/ML device.

Based on the provided text, here's an attempt to answer the questions, focusing on the information available regarding the contact lens rather than an AI/ML diagnostic system:

A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria or reported device performance for an AI/ML diagnostic in a table. Instead, it describes general safety and performance characteristics for a contact lens. The "performance" for this device relates to its physical properties and biocompatibility.

Acceptance Criteria (Implied from the document goals)	Reported Device Performance (from the "Testing" section)
Lenses are sterile for the indicated shelf-life.	Confirmed: "Lenses supplied in blister packages are sterile for the indicated shelf-life."
Finished lenses, packaging material, and extracts are non-toxic and non-irritating.	Confirmed: "The finished lenses, packaging material and extracts are non-toxic and non-irritating." (Based on in vitro and in vivo preclinical toxicology and biocompatibility tests)
Lens physical and material properties are consistent with currently marketed lenses.	Confirmed: "Lens physical and material properties are consistent with currently marketed lenses." (Based on non-clinical testing)
Safe and effective for indicated use when compared to predicate devices.	Confirmed: "The Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is as safe and effective as the predicate device..."
Clinical performance has been established.	Confirmed: "The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing."
Physical properties (Water Content, Oxygen Permeability, Specific Gravity, etc.)	Water Content: 58 ±2%Oxygen Permeability: 24.1 x 10-11 (cm²/sec)(ml O2/ml-mmHg)Specific Gravity: 1.14 (hydrated)Refractive Index (wet): 1.404Visible Light Transmission: >90%

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

The document mentions "a series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed." It also states, "The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing." However, specific sample sizes for these tests (whether animal or human subjects for the "clinical performance testing") are not provided. The data provenance (country, retrospective/prospective) is also not specified.
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)

This information is not applicable and not provided in the document as it pertains to a contact lens, not an AI/ML diagnostic system requiring expert-adjudicated ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device with a test set requiring adjudication.
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

This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device. The device itself is the contact lens, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the contact lens, the "ground truth" for safety and effectiveness appears to be established through:
- Biocompatibility and toxicology studies (in vitro and in vivo) to confirm non-toxicity and non-irritation.
- Sterility testing to confirm shelf-life.
- Physical and material property measurements compared against known acceptable ranges for contact lenses.
- Previous clinical performance testing of the etafilcon A material.
The sample size for the training set

This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device that requires a training set.
How the ground truth for the training set was established

This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2017

Tangible Science LLC % Bret Andre Consultant/Official Correspondent EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068

Re: K171125

Trade/Device Name: Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 5. 2017 Received: September 8, 2017

Dear Bret Andre:

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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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) K171125

Device Name

Etafilcon with Tangible Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses

Indications for Use (Describe)

Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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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.

The assigned 510(k) number is:	K171125
Applicant information:
Date Prepared:	October 10th, 2017
Name:	Tangible Science LLC
Address	173 Jefferson DriveMenlo Park CA 94025
Contact Person:	Vic McCray, MDPresident & CEO
Phone number:	1-650-241-1045
Consultant:	Bret AndreEyeReg Consulting, Inc6119 Canter LnWest Linn, OR 97068
Phone number	(503) 372-5226

Device Information:

Device Classification:	Class II
Product Code:	LPL; MVN
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Trade Name:	Etafilcon with TangibleTM Coating (etafilcon A) Soft(Hydrophilic) Daily Wear Contact Lens

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Predicate Devices:

Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

"UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear" . By UNICON Optical Co., LTD. 510(k) number: K141917 Primary Predicate
"IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Contact Lens" . by Art Optical Contact Lens, Inc. 510(k) number: K152046 Reference Predicate

Device Description:

The Etafilcon with Tangible """ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is available in an aspheric design and manufactured using the cast-molding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are crosslinked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization.

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The Physical properties of the lens are:

Refractive Index (wet)	1.404
Visible Light Transmission	>90%
Surface Character	hydrophilic
Water Content	58 ±2%
Specific Gravity	1.14 (hydrated)
Oxygen Permeability	24.1 x 10-11 (cm²/sec) (ml O2/ml-mmHg)

The lenses will be manufactured in the aspheric, toric, and multifocal design configurations with the following properties:

• Chord Diameter	12.0 mm to 15.00 mm
• Center Thickness	0.01 mm to 0.50 mm
• Base Curve	7.85 mm to 10.0 mm
• Power Range	+6.00D to -10.00D (in 0.25D steps)
- Cylinder	-0.75D to -2.50D (in 0.25D steps)
- Axis	10° to 180° (in 10° steps)
- Add	+1.00D to +2.50D (in 0.50D steps)

Indication for Use:

The Etafilcon with Tangible "1" Coating (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The Etafilcon with Tangible™ Coating (etafilcon A) TORIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism.

The Etafilcon with Tangible 101 Coating (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal.

Testing:

Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Etafilcon with Tangible " 1 Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses packaged in blister packaging. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.

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Test results of the non-clinical testing on the Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses demonstrate that:

Lenses supplied in blister packages are sterile for the indicated shelf-life, ●
The finished lenses, packaging material and extracts are non-toxic and non-irritating, and
Lens physical and material properties are consistent with currently ● marketed lenses.

Clinical Testing The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing.

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of daily wear soft contact lenses. The benefits to the patient are the same as those for other soft contact lenses.

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Substantial Equivalence:

The following matrix illustrates the production and material characteristics of
the Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens, as well as the predicate devices.

Substantial Equivalence Matrix

	Etafilcon with TangibleTMCoating (etafilcon A) Soft(Hydrophilic) Contact Lensfor Daily WearNew Device	UNICON (etafilcon A) Soft(Hydrophilic) Contact Lensfor Daily WearPredicate Device510(k) K141917	Art OpticalIntelliWave4 with HPT,Silicone Hydrogel(safrofilcon A)Predicate Device510(k) K152046
Intended Use	Indicated for the correction ofametropia (myopia and hyperopia)and/or are presbyopic in aphakic ornon-aphakic persons with non-diseased eye who may have 5.00 D orless astigmatism.	Indicated for the correction ofametropia (myopia and hyperopia) inaphakic or non-aphakic persons withnon-diseased eye who may have 1.00D or less astigmatism.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not apjakic persons with non-diseased eyes with myopia orhyperopia. The lens may also beprescribed for management ofirregular corneal conditions such askeratoconus and post graft fitting.
Functionality	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina
Indications	Daily wear. Soft (hydrophilic)Contact Lens	Daily wear. Soft (hydrophilic)Contact Lens	Daily wear. Silicone HydrogelSoft (hydrophilic) ContactLens
Production Method	Cast-Molded	Cast-Molded	Lathe-Cut
USAN name	etafilcon A	etafilcon A	safrofilcon A
Water Content (%)	58%	58%	65%
Oxygen Permeability	24.1 x 1011 (cm2/sec) (ml02/ml-mmHg)	30.8 x 1011 (cm2/sec) (ml02/ml-mmHg)	46.46 x 10-11 (cm2/sec) (ml O2/mlx hPa )
Specific Gravity	1.140	1.140	1.102

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.