DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in non-aphakic persons with non-diseased eyes.

DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use Daily Disposable Wear. DAILIES™ lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENS is a new daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with Nformylmethyl acrylamide).

The DAILIES™ (nelfilcon A) ONE-DAY contact lens is available in a spherical lens design of the following dimensions:

• Chord Diameter: 13.8
• Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00)
• Base Curve: 8.6 mm
• Powers: +4.00D to -8.00D (0.25D steps)
-6.50D to -8.00D (0.50D steps)

A clear lens has the following properties:

Specific gravity: 1.06
Refractive index: 1.38 (hydrated)
Light transmittance: ≥ 97%
Water content : 69% by weight in normal saline
Oxygen permeability 26 x 10-11 {(cm² /sec)(mi O2 /ml=mmHg)} at 35°C (Fatt corrected).

Lenses are supplied sterile in foil sealed blister packs containing isotonic buffered saline solution. The packaging components have tested non-toxic when evaluated in in-vitro and in-vivo laboratory studies, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister packs are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Stability study data currently supports a thirty (30) month shelf-life for the DAILIÉS™ (nelfilicon A) ONE-DAY soft contact lens in foil packaging. Shelf-life studies are ongoing to determine extension of expiration dating.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining specific, quantifiable acceptance criteria. It broadly states that the device performed satisfactorily and demonstrated similar overall performance in key areas. The acceptance criteria essentially appear to be "not worse than predicate devices" and "performing satisfactorily."

Acceptance Criteria (Inferred from text)	Reported Device Performance
Nonclinical:
Non-toxic	"The lens material is not toxic"
Non-irritating extracts	"the extracts non irritating"
No residual lens starting materials	"Extracts of the lens do not show the presence of residual lens starting materials."
Consistent physical/material properties with marketed lenses	"Lens physical and material properties are consistent with industry marketed lenses."
Unaffected by peroxide disinfection systems	"The lens material remains unaffected, with respect to lens properties, by exposure to peroxide disinfection systems."
Similar uptake and release profiles (preservatives) to predicate device	"The amount of preservatives in the tested care regimens show similar uptake and release profiles to the predicate device."
Clinical:
Satisfactory performance in vision	"demonstrated similar overall performance in the clinically relevant areas of vision"
Satisfactory performance in health	"demonstrated similar overall performance in the clinically relevant areas of... health"
Satisfactory performance in comfort	"demonstrated similar overall performance in the clinically relevant areas of... comfort"
Satisfactory performance in fit	"demonstrated similar overall performance in the clinically relevant areas of... fit"
Overall performance similar to concurrent controls	"evaluation of the DAILIES™ (nelfilcon A) ONE-DAY Clinical lens demonstrated similar overall performance... compared to concurrent controls"

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

Test Set Sample Size: The document does not specify the exact sample size for the clinical studies. It mentions "separate studies investigating both daily wear and daily disposable wearing modalities" and "three month clinical evaluations." However, specific numbers of subjects or lenses are not provided.
Data Provenance: The studies were described as "conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812)." This typically implies prospective clinical trials. The country of origin is not explicitly stated but is implicitly the USA given the FDA 510(k) submission context. The studies were prospective clinical trials.

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

This information is not provided in the document. For contact lenses, the "ground truth" for clinical performance is typically based on ophthalmologist or optometrist examinations and patient-reported outcomes. The document refers to "clinical evaluations" and "clinically relevant areas," implying examination by qualified professionals, but the number and specific qualifications of these experts are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study, as typically understood in the context of diagnostic AI, was not conducted. This device is a contact lens, not a diagnostic imaging device requiring multiple readers to interpret cases. The clinical studies compared the lens's performance to predicate devices and focused on general safety, effectiveness, and clinical outcomes (vision, health, comfort, fit) rather than diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to a contact lens. The "device" itself is a physical product (contact lens), not an algorithm. Therefore, no standalone algorithm performance study was performed or is relevant.

7. The Type of Ground Truth Used

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

Clinical Assessments: Evaluations by clinicians (ophthalmologists/optometrists) of objective measures related to ocular health, fit, and visual acuity.
Patient-Reported Outcomes: Subjective comfort and vision satisfaction reported by the study participants.
Comparison to Predicate Devices: Performance was assessed relative to the established safety and effectiveness of the existing predicate lenses.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical product (contact lens), not an AI/ML algorithm that requires a "training set" of data. The manufacturing and design process for contact lenses involves extensive R&D and material science, but this isn't framed as a "training set" in the machine learning sense.

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

This information is not applicable for the reasons stated in point 8.

Summary

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K963487
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CIBA Vision	CIBA Vision® Corporation11460 Johns Creek ParkwayDuluth, GA USA 30155	NOV 27 1996
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DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens

510(k) Summary of Safety and Substantial Equivalence

510(k) Summary

1. Submitter Information:

Company:	Ciba Vision Corporation11460 Johns Creek ParkwayDuluth, Georgia 30155 -1518
Contact Person:	Alicia M. Plesnarski, RACSenior Associate, Regulatory Affairs
Telephone:	770-418-3924
FAX:	770-418-3033
Date Prepared:	August 30, 1996

2. Device Name:

Common Name: Soft Contact Lens ●
Trade/Proprietary Name: DAILIES™ ONE-DAY CONTACT LENS . (nelfilcon A)
. Daily Wear Classification Name: Soft (hydrophilic) Contact Lens
. Device Classification: Class II {21 CFR 886.5925 (b) (1)}

3. Predicate Device(s):

Two predicate lenses were selected to address both intended use (disposable) and material type (Group II / PVA) and include:

. NewVues® (vifilcon A), FDA Group IV, disposable contact lenses for daily or extended wear, CIBA® Vision Corporation - P820021
Excelens® (atlafilcon A), FDA Group II, soft contact lenses for daily . or extended wear, CIBA® Vision Corporation - P890029

{1}------------------------------------------------

CIBA	CIBA Vision® Corporation
Vision	11460 Johns Creek Parkway
	Duluth, GA USA 30155

	DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens
	510(k) Summary of Safety and Substantial Equivalence

4. Description of Device:

The DAILIES™ (nelfilcon A) ONE-DAY contact lens is available in a spherical lens design of the following dimensions:

• Chord Diameter:	13.8
• Center Thickness:	0.09 to 0.17 mm (0.10 at -3.00)
• Base Curve:	8.6 mm
• Powers:	+4.00D to -8.00D (0.25D steps)-6.50D to -8.00D (0.50D steps)

A clear lens has the following properties:

Specific gravity: 1.06 ● Refractive index: 1.38 (hydrated) Light transmittance: ● ≥ 97% . Water content : 69% by weight in normal saline ● Oxygen permeability 26 x 10-11 {(cm² /sec)(mi O2 /ml=mmHg)}
at 35°C (Fatt corrected).

5. Indications for Use:

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Image /page/2/Picture/0 description: The image shows the logo and address of CIBA Vision Corporation. The address is 11460 Johns Creek Parkway, Duluth, GA USA 30155. The image also contains the text "DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens".

510(k) Summary of Safety and Substantial Equivalence

6. Description of Safety and Substantial Equivalence:

A series of nonclinical tests and clinical studies were performed to demonstrate the safety and effectiveness of the DAILIES™ (nelfilcon A) ONE-DAY contact lens, and establish substantial equivalence to currently marketed, predicate (control) lenses. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and in conformance to applicable device requiations. Results demonstrate the lens is non-toxic and biocompatible, and has material characteristics comparable to other currently marketed soft contact lenses. Clinically, the lens has performed satisfactorily in separate studies investigating both daily wear and daily disposable wearing modalities. Results from all tests demonstrate the substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses.

Nonclinical Testing:

A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens. All nonclinical toxicology tests were conducted in accordance with the GLP regulation (21 CFR Part 58).

The results of the nonclinical testing on the DAILIES™ (nelfilcon A) ONE-DAY contact lens demonstrate that:

. The lens material is not toxic and the extracts non irritating.
Extracts of the lens do not show the presence of residual lens starting . materials.
Lens physical and material properties are consistent with industry . marketed lenses.
The lens material remains unaffected, with respect to lens properties, by exposure to peroxide disinfection systems. The amount of preservatives in the tested care regimens show similar uptake and release profiles to the predicate device.

Clinical Testing:

The DAILIES™ (nelfilcon A) ONE-DAY contact lens was investigated in both daily wear and daily disposable clinical studies. The three month clinical evaluations were conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812). Studies assessed the safety and effectiveness, and clinical performance as compared to two predicate control lenses.

evaluation of the DAILIES™ (nelfilcon A) ONE-DAY Clinical lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under both re-use (daily wear) and single-use (disposable wear) conditions.

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Image /page/3/Figure/0 description: The image shows the logo and contact information for CIBA Vision Corporation. The address listed is 11460 Johns Creek Parkway, Duluth, GA USA 30155. The image also contains the text "DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens" and "510(k) Summary of Safety and Substantial Equivalence".

Substantial Equivalence:

The DAILIES™ (nelfilcon A) ONE-DAY contact lens is similar to other daily wear soft contact lenses in terms of water content (≥ 50% water), Dk values, ionic characteristics (Group II, non-ionic), clinical performance, and indications for use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen should replacement lenses not be available and emergency lens care is needed.

Any differences which may exist between the (nelfilcon A) contact lens and other Group II or Group IV soft hydrophilic plastic contact lenses do not adversely effect the safety and effectiveness of the 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.