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The CONTAFLEX GM3 58 (acofilcon A) Spherical 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 off75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. Evecare 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.

The CONTAFLEX GM3 58% Spherical Soft Contact Lenses are fabricated from acofilcon 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, (acofficon A) is a terpolymer based on high purity Glycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lens is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121. The acofilcon 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 (acofilcon 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 58% water by weight.

This 510(k) premarket notification for the CONTAFLEX GM3 58% (acofilcon A) Spherical Soft Contact Lens focuses on demonstrating substantial equivalence to a predicate device rather than setting and meeting de novo acceptance criteria. Therefore, the information provided relates primarily to the comparison with the predicate device and the safety and efficacy of the new device.

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Acceptance Criteria and Device Performance

There are no explicit "acceptance criteria" in the format of specific thresholds for performance metrics (e.g., minimum visual acuity improvement, maximum adverse event rate) that the device must meet independently. Instead, the study aims to show substantial equivalence to the predicate device, the "BENZ 55G" contact lens. This means the new device is considered acceptable if its safety and efficacy are no different than the legally marketed predicate device.

The "device performance" is reported through preclinical and clinical studies demonstrating this equivalence.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 122 eyes (61 patients) were enrolled in the clinical study. 100 eyes (50 patients) completed the study.
   • Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It mentions "CONTAMAC Ltd." with an address in "Saffron Walden, Essex England CB11 4JX," which suggests the study or at least the sponsor is based in the UK. The study is described as a "clinical study carried out." It is a prospective study as patients were "entered into the study" and followed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: 5 investigators were involved in the clinical study.
   • Qualifications of Experts: Their specific qualifications (e.g., "ophthalmologist with X years of experience") are not provided in the document. They are referred to as "investigators," implying medical professionals involved in clinical eye care.

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

   • The document does not describe any specific adjudication method for the clinical study data (e.g., for adverse events or efficacy assessments). It simply lists the safety and efficacy measures that were tracked.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a contact lens and does not involve AI assistance or human readers interpreting medical images.

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

   • Not applicable. This is a contact lens, not an algorithm. The "standalone" performance here would refer to the lens's physical and optical properties, and its performance in daily wear, which was assessed in the preclinical and clinical studies.

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

   • For the preclinical studies, laboratory testing and standardized methods (e.g., ISO 10993-5, revised Fatt method) were used to determine material properties and toxicity.
   • For the clinical study, the "safety and efficacy measures" (Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints, Keratometry Changes, Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time) are essentially clinical outcomes data and clinical assessments by the investigators. These assessments, presumably based on established ophthalmological practices, serve as the "ground truth" for the lens's performance in vivo.

7. The sample size for the training set:

   • Not applicable in the context of this device. This is a medical device (contact lens), not an AI algorithm requiring a "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design, based on established material science and ophthalmological principles.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as #7.

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The HD (polymacon) Aspheric 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 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The PV (polymacon) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyonic. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The PVT (polymacon) Multi-Aspheric Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The HD/HDT, PV/PVT (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-I his consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses that contain a unique timing pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color subsequently processed to morporate and noloring effect. Lenses are tinted with one or a combination of one or more of the following pigments, 'listed' color additives.

Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126)

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface. The (polymacon) soft hydrophilic sugary ocyone the minous coming a ace. 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 mannualios in a rany arguited warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The provided document is a 510(k) Premarket Notification for soft contact lenses. It does not describe an AI medical device or a study involving acceptance criteria for such a device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. Therefore, it does not contain the information requested in the prompt related to AI device performance and studies.

Specifically, the document includes:

• A table of substantial equivalence attributes for the subject device and predicate devices (manufacturing, indication, intended use, manufacturing method, material name, water content, toxicity). This is not an acceptance criteria and reported device performance table for an AI device.
• No sample sizes for test or training sets are mentioned, as this is not a study assessing AI performance.
• No information on experts for ground truth establishment or adjudication methods.
• No multi-reader multi-case (MRMC) comparative effectiveness study is discussed.
• No standalone (algorithm only) performance is provided.
• No ground truth type is discussed in the context of an AI device.

The document is a regulatory submission for contact lenses, not an evaluation of an AI-powered diagnostic or assistive tool.

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