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The FireSoft-SiHy sphere (efrofilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The FireSoft-SiHy toric (efrofilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The FireSoft-SiHy multifocal (efrofilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.

The FireSoft-SiHy multifocal toric (efrofilcon A) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The FireSoft-IC (efrofilcon A) Soft Contact Lenses for daily wear are indicated for and may be prescribed in otherwise non-diseased eves that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

The FireSoft-55 sphere (methafilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The FireSoft-55 toric (methafilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The FireSoft-55 multifocal (methafilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.

The FireSoft-55 multifocal toric (methafilcon A) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The FireSoft-49G sphere (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

TheFireSoft-49G toric (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

TheFireSoft-49G multifocal (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.

The FireSoft-49G multifocal toric (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The FireSoft-54G sphere (hioxifilcon D) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The FireSoft-54G toric (hioxifilcon D) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The FireSoft-54G multifocal (hioxifilcon D) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.

The FireSoft-54G multifocal toric (hioxifilcon D) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

The FireSoft-SiHy (efrofilcon A) and FireSoft-IC (efrofilcon A) Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a group 5, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for individualized RX. It consists of 26% effofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

The unique base curve geometry of the FireSoft-IC lens has a spheric optic zone with an aspheric periphery. The front curve has a reinforced optic zone with a center thickness of.36mm (standard), with a special lenticular zone for structural stability. The design incorporates pressure balancing holes to equalize the pressure between the front and back of the lens to improve: Optic stability, Oxygen transmissibility, Tear exchange, and Eliminate air bubbles.

In the hydrated state, the lens conforms to the curvature of the comea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (effofileon A) soft hydrophilic contact lens has a spherical 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The Physical properties of the lens are:
Refractive Index: 1.38
Light Transmission: greater than 97%
Surface Character: hydrophilic
Water Content: 74 %
Specific Gravity: 1.048 (hydrated)
Oxygen Permeability: 59.8 x 10-11 (cm²/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method).

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal and irregular comea configurations with the following features and properties.
Chord Diameter: 12.0 mm to 16.00 mm
Center Thickness: 0.01 mm to 0.50 mm
Base Curve: 8.0 mm to 9.5 mm
Power Range: -20.00D to +20.00D in 0.25 steps
Cylinder Power (Toric): -0.25D to -10.00D
Add Power* (Multifocal): +0.50D to +3.00D

• Add Power* (Multifocal) . * not applicable for the FireSoft-IC

The FireSoft-55 (methafilcon A) Hydrogel Soft Contact Lenses are fabricated from methafilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The ionic lens material, (methafilcon A) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The methafilcon A name has been adopted by the United States Adopted Names Council (USAN).

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 (methafilcon A) soft hydrophilic contact lens has a spherical 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 55% water by weight. The physical properties of the lens are:
Refractive Index: 1.405 (hydrated)
Light Transmission (clear): greater than 94%
Light Transmission (tinted): greater than 94%
Water Content: 55% ± 2%
Specific Gravity: 1.067
Oxygen Permeability: 19.6 X 10-11 (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

The FireSoft-55 lenses will be manufactured in spherical, toric and multifocal configurations with the following features.
Chord Diameter: 12.0 mm to 16.00 mm
Center Thickness: 0.01 mm to 0.50 mm
Base Curve: 8.0 mm to 9.5 mm
Power Range: -20.00D to +20.00D in 0.25 steps
Cylinder Power (Toric): -0.25D to -10.00D
Add Power (Multifocal): +0.50D to +3.00D

The FireSoft-49G (hioxifileon B) Hydrogel Soft Contact Lenses are fabricated from (hioxifilcon B) which is a non-ionic, ultra high molecular weight copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 51% hioxifiloon B and 49% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility handling tint, phthalocyanato (2) - (copper). The hioxifilcon B name has been adopted by the United States Adopted Names Council (USAN).

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 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:
Refractive Index: 1.425 (hydrated)
Light Transmission (clear): greater than 95%
Light Transmission (tinted): greater than 95%
Water Content: 49 % ± 2%
Specific Gravity: 1.137
Oxygen Permeability: 15.0 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).

The FireSoft-49G lenses will be manufactured in spherical, toric and multifocal configurations with the following features.
Chord Diameter: 12.0 mm to 16.00 mm
Center Thickness: 0.01 mm to 0.50 mm
Base Curve: 8.0 mm to 9.5 mm
Power Range: -20.00D to +20.00D in 0.25 steps
Cylinder Power (Toric): -0.25D to -10.00D
Add Power (Multifocal): +0.50D to +3.00D

The FireSoft-54G (hioxifileon D) Hydrogel Soft Contact Lenses are fabricated from (hioxifilcon D) which is a non-ionic, ultra high molecular weight copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility handling tint, phthalocyanato (2) - (copper). The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:
Refractive Index: 1.408 (hydrated)
Light Transmission (clear): greater than 95%
Light Transmission (tinted): greater than 95%
Water Content: 54 % ± 2%
Specific Gravity: 1.137
Oxygen Permeability: 23.0 X 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

The FireSoft-54G lenses will be manufactured in spherical, toric and multifocal configurations with the following features.
Chord Diameter: 12.0 mm to 16.00 mm
Center Thickness: 0.01 mm to 0.50 mm
Base Curve: 8.0 mm to 9.5 mm
Power Range: -20.00D to +20.00D in 0.25 steps
Cylinder Power (Toric): -0.25D to -10.00D
Add Power (Multifocal): +0.50D to +3.00D

ALL FireSoft Soft Contact Lenses are supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate name, 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.

This document is a 510(k) summary for Firestone Optics' FireSoft line of soft contact lenses. The submission demonstrates substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria (Material Properties) and Reported Device Performance

The acceptance criteria for the new FireSoft devices are implicitly that their material properties and intended uses are "identical" or "the same as" those of their respective predicate devices. The document provides detailed material properties for each FireSoft lens type, which are directly compared to their predicate devices in the "Substantial Equivalence" matrix.

Here's a summary table based on the provided information, focusing on the key physical properties presented for each lens type:

The study (510(k) submission K133403) claims that the new FireSoft devices meet acceptance criteria by demonstrating substantial equivalence to their respective predicate devices. This is established by showing that the new devices are identical in material, manufacturing process, functionality, intended use, FDA Group # designation, USAN name, water content, oxygen permeability, and specific gravity to already cleared devices.

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: "The clinical performance of the (efrofilcon A) (methafilcon A) (hioxifilcon B) (hioxifilcon D) contact lens materials have been previously established, and therefore was not required for this 510(k)."

This indicates that no new clinical test set data was generated or used for this specific 510(k) submission. The reliance is entirely on the previously established clinical performance of the predicate devices. Therefore, details regarding sample size, data provenance, or retrospective/prospective nature of new clinical data are not provided.

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)

Since no new clinical test set was required for this 510(k) submission, information about experts for ground truth establishment is not applicable and not provided. The substantial equivalence argument relies on the inherent material properties and design being identical to already approved devices, whose clinical performance was established in prior submissions.

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

Not applicable, as no new clinical test set was required for this 510(k) submission.

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 submission is for medical devices (contact lenses), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI effect size are irrelevant.

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

Not applicable. This is a medical device, not an algorithm.

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

The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices. This was likely based on a combination of clinical outcomes data from previous studies that led to the predicate devices' clearance, as well as material property testing and biocompatibility assessments. The current submission relies on the fact that the material, design, and manufacturing are identical to these already-proven devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a training set.

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

Not applicable, as there is no training set for this device.

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