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The Optimum GP with HPT (roflufocon C, D, and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only

The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

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

The Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (roflufocon C, D, and E) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens are packaged and shipped "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum GP with HPT lenses is the PolyVial Contact Lens Case. The Optimum GP with HPT lenses are packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

In the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380mm.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:

• 7.0mm to 22.0mm Chord Diameter: ●
• Center Thickness: Varies
• Base Curve:
• Spherical Powers:
• Toric Powers:
• Add Powers: ●

5.0mm to 8.0mm -20.00 Diopters to +20.00 Diopters up to -10.00 Diopters

• up to +4.00 Diopters

The document describes the K161100 submission for the "Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses." The purpose of this 510(k) submission is to introduce new technology to existing contact lenses by including Hydra-PEG Technology (HPT) to improve wettability.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criterion and performance metric highlighted is improved wettability, specifically measured by the captive bubble dynamic contact angle. The document compares the new HPT-coated lenses to the uncoated predicate lenses.

Interpretation: The HPT-coated lenses demonstrate a significant reduction in the average captive bubble dynamic contact angle across all three roflufocon materials (C, D, and E), indicating improved wettability as intended.

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

• Test Set Sample Size for Wettability: For the wettability measurement (contact angle), the sample size was n=3 for each material (roflufocon C, D, and E), for both uncoated and HPT-coated lenses.
• Data Provenance: The document does not explicitly state the country of origin for the wettability data. It is an in-vitro study, comparing the physical properties of the lenses. The general statement "Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols" suggests a controlled laboratory environment. The provided information does not indicate if it's retrospective or prospective, but due to its nature as a controlled lab test, it would be considered prospective for the specific test.

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

The wettability test (captive bubble dynamic contact angle) is an objective physical measurement performed in a laboratory, not a subjective assessment requiring human experts to establish "ground truth" in the way clinical diagnosis or image interpretation would. Therefore, the concept of "experts" as described in the prompt is not applicable to this specific performance criterion.

4. Adjudication Method for the Test Set

Since the wettability test is a direct physical measurement, it does not involve human adjudication for establishing ground truth. The measurement is taken by instrumentation, and the results are quantitative. Therefore, no adjudication method (e.g., 2+1, 3+1) was used or is relevant for this specific test.

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

No MRMC comparative effectiveness study was done for this device. The submission focuses on the chemical and physical properties of the contact lens material and its surface coating, not on diagnostic performance or human-in-the-loop clinical effectiveness related to AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This device is a medical device (contact lens), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance measured is that of the physical device itself.

7. Type of Ground Truth Used

For the wettability performance, the "ground truth" is established by direct physical measurement using standardized laboratory methods (specifically, the captive bubble dynamic contact angle). This is an objective measurement of a material property rather than a subjective clinical assessment or pathology result.

8. Sample Size for the Training Set

This submission addresses a medical device (contact lens) and its material properties, not an AI or machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable. The testing performed is to characterize the physical properties of the device.

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

As stated above, this is not an AI/ML development, so the concept of a "training set" and its "ground truth" establishment is not applicable.

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