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The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopter or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10 Diopters.

Eye care practitioners may prescribe the lens 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 disinfection system.

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lenses are hemispherical shells and are available as multifocal lens designs. The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is fabricated from Hioxifilcon D, which is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-, Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linkned with ethylene glycol dimethacrylate (EGDMA). It consists of 46% Hioxifilcon Datod 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).

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, rransparent 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.

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is substantially equivalent to the predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens cleared under 510(k) K062854. The submission does not describe a study to prove acceptance criteria in the traditional sense of a clinical trial with a test set, ground truth, or statistical analysis. Instead, it relies on substantial equivalence to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are implicitly established by demonstrating that its characteristics are substantially equivalent to those of the predicate device (Benz-G 4X Lathed Lens, K062854). The relevant "performance criteria" are the physical, chemical, and intended use specifications, which are compared side-by-side.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses." Therefore, there was no separate test set of subjects/data used for clinical evaluation of the new device. The data provenance would be inherent in the predicate device's original clearance.

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)

Not applicable, as no new clinical study with a test set was conducted for the new device. The ground truth for the predicate device would have been established at the time of its clearance (K062854).

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

Not applicable, as no new clinical study with a test set was conducted for the new device.

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, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a contact lens, not an algorithm.

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

Not applicable for a new clinical study. The basis of equivalence is the identical physical and chemical properties and manufacturing process to the predicate device, with an expanded intended use to include presbyopia.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted.

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

Not applicable, as no new clinical study was conducted.

Study Proving Acceptance Criteria:

The study proving the acceptance criteria for the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses is based on a side-by-side comparison testing with its predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens (K062854).

The document explicitly states:

• "Side by side comparison testing was conducted on the Benz-G 4X (Hioxifilcon D) Lathed Lens already cleared under 510(k) K062854, and Multifocal Lenses manufactured by Benz Research & Development from Hioxifilcon D material."
• "This Benz-G 4X (Hioxifilcon D) material is identical to the previously cleared Benz-G 4X (Hioxifilcon D) under K062854."
• "The Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses have the identical manufacturing process (lathe-cut versus lathed-cut) as the marketed lens Benz-G 4X (Hioxifilcon D) Lathed."

The conclusion drawn from this comparison is that the new device is substantially equivalent to the predicate device in terms of:

• Intended use (with the addition of presbyopia correction)
• Materials
• Toxicological properties
• Physicochemical properties

The primary difference, an additional optical zone for multifocal correction, is presented as an enhancement to visual acuity correction rather than a fundamental change requiring new extensive clinical testing, given the identical base material and manufacturing process. The FDA's August 9, 2010 letter confirms this determination of substantial equivalence.

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The Benz-G 4X 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters. Eye care practitioners may prescribe the lens 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 disinfection system.

Benz-G 4X 54% (hioxifilcon D) lathed soft contact lenses are hemispherical shells and are available as spherical or toric lens designs. The Benz-G 4X 54% (hioxifilcon D) lathed soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifileon D and 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper). 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 and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The provided text describes a 510(k) premarket notification for a soft contact lens, the Benz-G 4X (hioxifilcon D) Lathed Sphere and Toric Lenses. The submission asserts substantial equivalence to a predicate device, Extreme H2O® 54% (hioxifilcon D) molded soft contact lens (K051430).

Based on the document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative clinical trial sense (e.g., a specific sensitivity or specificity threshold). Instead, the substantial equivalence is based on a comparison of material properties, intended use, and non-clinical performance to a predicate device. The performance characteristics are compared as follows:

2. Sample size used for the test set and the data provenance

The document states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (hioxifilcon D) lathed lens." Therefore, there is no "test set" in the context of a clinical trial with human subjects. The data provenance is from non-clinical testing (e.g., Agar Diffusion Test, Systemic Injection Test, Primary Ocular Irritation Test) performed in accordance with 21 CFR, Part 58. The specific number of samples for these tests is not provided, nor is the country of origin, though it's implied to be from the manufacturer's testing.

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

Not applicable. As clinical studies were not deemed necessary, there was no "ground truth" derived from human experts in a clinical setting. The non-clinical tests rely on standardized methodologies and interpretation by qualified laboratory personnel, rather than expert consensus on medical images or diagnoses.

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

Not applicable. There was no "test set" requiring adjudication by multiple readers or experts. The non-clinical tests have objective endpoints.

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 soft contact lens, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

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

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

For the non-clinical tests, the "ground truth" is derived from the objective results of the standardized biological and chemical tests. For example, in the Agar Diffusion Test, the absence of a zone of inhibition would be considered "non-cytotoxic," which is an objective observation rather than an interpretive "ground truth" from an expert. Similarly, for the systemic injection test, the "ground truth" comes from comparing biological reactions to control articles, and for ocular irritation, the "ground truth" is the observation of non-irritancy based on established criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set." The manufacture of the contact lens relies on established materials and processes, not a machine learning model.

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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