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Sphere/Asphere
Innova Vision Sphere and Asphere (Etafilcon 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 acuty.

Toric
Innova Vision Toric (Etafilcon 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 (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in 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 (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves 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 (Etafilcon 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 (Etafficon 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 (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region.

The properties of the lens are:
Chord Diameter: 13.00 mm to 15.00 mm
Center Thickness 0.080 mm to 0.580 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range
Sphere Power: -20.00 D to +20.00 D in 0.25 D steps
Cylinder Power (Toric): -0.25 D to -2.25 D in 0.25 D steps
Cylinder Axis (Toric): 10 degrees to 180 degrees in 10 degrees steps
Multifocal Power: +0.25 D to +4.00 D in 0.25 D steps
Specific Gravity: 0.98 to 1.12
Refractive Index: 1.400 plus or minus 0.005
Visible Light Transmittance: > 95%
UVA (315 nm380 nm) Absorbance < 30%
UVB (285 nm315 nm) Absorbance < 5%
Surface Character: Hydrophilic
Water Content: 58% plus or minus 2%
Oxygen Permeability: 24 times 10 to the power of -11 (cm squared dot ml O2)/(sec dot ml dot mmHg) plus 20%

The provided text describes the regulatory submission for the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954). The submission demonstrates substantial equivalence to predicate and reference devices, primarily through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative format for all aspects. Instead, it states that "All the test results met the requirements of product specification" and "The results complied with the testing guidance." It provides specific performance characteristics for the subject device and compares them to predicate and reference devices, asserting non-significant differences.

Based on the "Description of the Device" and the comparison tables, here's a summary of performance characteristics presented as implicit acceptance criteria and reported performance:

The document notes that no specifications were significantly different between the subject, predicate, and reference devices, and that differences in material properties (water content, oxygen permeability, refractive index) were "not significantly different and meets the requirements." The production method (cast-molded vs. spin-casting) was deemed "Equivalent" because "the performance of the device are not affected and meet the requirements."

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing."

Therefore, there is no "test set" in the context of human clinical data, nor is there information about data provenance (e.g., country of origin, retrospective/prospective) because such data was not utilized. The non-clinical tests would have involved specific numbers of contact lenses or samples of materials, but these specific sample sizes are not detailed in the provided summary.

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

Not applicable, as no clinical test data or human ground truth assessment was performed for the substantial equivalence determination.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test data requiring adjudication was used.

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 device is a contact lens and does not involve AI assistance or human readers for diagnostic interpretation.

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

Not applicable. This device is a contact lens and does not involve algorithms or AI.

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

For the non-clinical tests, the "ground truth" implicitly refers to recognized consensus standards and established product specifications (e.g., ISO, ASTM standards, and Innova Vision's own product requirements). The reported performance meeting these standards and specifications serves as the "ground truth" for non-clinical aspects.

8. The sample size for the training set

Not applicable. This device is a contact lens; it does not involve a training set for an algorithm.

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

Not applicable, as no training set for an algorithm was used.

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