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OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).

AI/ML Overview

The provided text is a 510(k) summary for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. It details the similarity of the device to predicate devices rather than providing a standalone clinical study with specific acceptance criteria and performance results for the new device.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment for a standalone study is not explicitly present in the provided document. The document refers back to predicate device studies (K213216, K191929, K213119) for clinical and non-clinical data.

However, I can extract the material properties and their tolerances which act as performance criteria for the device itself.

Acceptance Criteria and Reported Device Performance

The provided document lists material properties and tolerances (acting as acceptance criteria) for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. Since this is a 510(k) summary demonstrating substantial equivalence to predicate devices, the performance is generally asserted to meet these specified ranges, implying the device does meet these criteria. The table below presents these:

Parameter	Acceptance Criteria (Range/Tolerance)	Reported Device Performance (Implied adherence to these ranges)
Chord Diameter	13.00 mm to 15.00 mm, ±0.20 mm	Meets specified range
Center Thickness	0.080 mm @ -3.00 D; When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5%	Meets specified range
Base Curve	8.00 mm to 9.50 mm, ±0.20 mm	Meets specified range
Back Vertex Power (F'v)	+20.00D to -20.00D; When 0.00 1.50 D→± 5°	Meets specified range
Multifocal Power	+0.25 D to +4.00 D (in 0.25 D steps), ±0.25D	Meets specified range
Surface Appearance	Lenses should be clear with no surface defect	Meets specified criterion
Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg))	100, ±20%	Meets specified range (100 edge-corrected)
Light Transmittance - Tinted (@ 380-780nm)	95%, ±5%	Meets specified range (implied to be ≥ 95%)
Ultraviolet Radiation Transmittance

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K Number

K213119

Device Name

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Manufacturer

Innova Vision Inc.

Date Cleared

2022-05-13

(228 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K191929,K153766

Intended Use

Sphere/Asphere
Innova Vision Sphere and Asphere (Hioxifilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric
Innova Vision Toric (Hioxifilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal
Innova Vision Multifocal (Hioxifilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric
Innova Vision Multifocal Toric (Hioxifilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

Device Description

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (59% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization. Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for handling and contains 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 50% in the UVA region.

AI/ML Overview

The document describes the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens and its substantial equivalence determination, rather than a study proving the device meets specific acceptance criteria in a clinical trial setting. The substantial equivalence relies on non-clinical testing and comparison to predicate devices.

Here's an analysis of the provided information, framed to address your request for acceptance criteria and study details:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the typical quantitative sense for a clinical study with primary endpoints. Instead, it demonstrates compliance with recognized standards and similarity to predicate devices. The "reported device performance" is primarily the physical and chemical properties of the lens and the results of non-clinical tests meeting specific standard requirements.

Characteristic / Test	Acceptance Criteria (Standard/Predicate Equivalence)	Reported Device Performance (Innova Vision Hydrogel)
Material	Hioxifilcon A (Same as predicates)	Hioxifilcon A (random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization, tinted with Reactive Blue 19, contains UV blocking additive 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate)
Water Content	59% ± 2% (Same as predicates)	59% ± 2%
Oxygen Permeability	$20.76 \times 10^{-11} (cm^2/sec)(mlO_2/ml \times mm Hg)$ (Predicate Clalen 58), $25 \times 10^{-11} (cm^2/sec)(mlO_2/ml \times mmHg)$ (Reference UNICON Hydrogel) - "Not significantly different and meets the requirement"	$25 \times 10^{-11} (cm^2/s)/(ml O_2/[ml \cdot mmHg]) \pm 20%$
Refractive Index	1.403 (hydrated) (Predicate Clalen 58), 1.404 (hydrated) (Reference UNICON Hydrogel) - "Not significantly different and meets the requirement"	$1.400 \pm 0.005$
UVB Absorbance	95% (meaning 50% (meaning 95%
Sterilization Validation & Shelf Life	Compliance with ISO 11138-1, -3, ISO 11137-1, -2, ISO 17665-1, ASTM F1929-15, ISO 18369-3, ISO 11987, ISO 11737-2, ASTM F2338-09 requirements.	All test results met the requirements of product specification.
Biocompatibility	Compliance with ISO 10993-1, -5, -12, -10, -11 and ASTM F750-87 requirements.	All test results met the requirements of product specification.
Performance (Oxygen Permeability, Tensile Strength, Refractive Index, Water Content, Specific Gravity, Extractables, Luminous Transmittance, Lens Compatibility with Multi-Purpose Solution, Osmolality Determination, pH Value Determination, Geometric Parameters)	Compliance with ISO 18369-4, ASTM D882-18, ASTM D1708-18, and ISO 18369-3 requirements.	All test results met the requirements of product specification.
Indications for Use	Substantially equivalent to predicate and reference devices, with "few different wordings [that] do not affect the equivalence."	See detailed indications on page 2, 5, 6, 10, 11, and 12 for Sphere/Asphere, Toric, Multifocal, and Multifocal Toric lenses. Powers from -20.00 to +20.00 diopters, astigmatic correction up to -10.00 diopters, add powers up to +4.00 diopters. Frequent/planned replacement wear or single-use disposable wear.

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

Sample Size: Not applicable. This submission relies on non-clinical testing (e.g., laboratory tests on lens samples) and a comparison to predicate devices, not a clinical "test set" of patients.
Data Provenance: The tests were conducted internally by Innova Vision Inc. or contracted labs on samples of the device. The data is based on these non-clinical tests. The country of origin of the data is implicit to be Taiwan, where Innova Vision Inc. is located. It is prospective data in the sense that the tests were specifically performed for this 510(k) submission, but it's not "prospective clinical trial data."

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

Not applicable. As no clinical test set was used, there was no ground truth for patient outcomes established by experts. Ground truth for the non-clinical tests would be the measurement standards themselves and the validation of the testing methodologies.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set or adjudication of patient outcomes was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is for image-based diagnostic devices comparing human readers' performance with and without AI assistance. This device is a contact lens and does not involve AI or diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for this submission are the international and national standards for contact lens materials, manufacturing, biocompatibility, and performance, as well as the established safety and effectiveness profiles of the chosen predicate devices. The properties of the Innova Vision lens are compared to these established benchmarks and to the predicate devices. For example, oxygen permeability and refractive index values are compared to the predicate's values, and non-clinical tests conform to ISO and ASTM standards.

8. Sample Size for the Training Set:

Not applicable. This submission does not involve machine learning or AI models with a "training set." The device is a physical product.

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

Not applicable. See point 8.

In summary:

This 510(k) submission (K213119) for the Innova Vision Hydrogel Contact Lens is a Traditional 510(k) based on demonstrating substantial equivalence to existing legally marketed predicate devices (Clalen 58 and UNICON Hydrogel lenses). The "acceptance criteria" are compliance with established regulatory standards and the demonstration that the device's physical, chemical, and performance characteristics are either identical or not significantly different from the predicate devices. The "study" that proves this is a series of non-clinical laboratory tests performed on the contact lens samples, rather than a clinical trial with human subjects.

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