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The Intelliwave4, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in 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 Intelliwave4, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The Intelliwave4, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in 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 IntelliWave4, irregular cornea (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

IntelliWave4 UV lenses help protect against transmission of harmful UV radiation to the eye.

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 Intelliwave4 Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon 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 (safrofilcon A) is a 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 Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon 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 (safrofilcon 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.

In the Intelliwave4 Contact Lens with UV Blocker and center thickness of 0.18mm, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2-(4-Benzoyl-3-hydroxyphenoxy)ethyl acrylate. The UV blocking for Intelliwave4 lenses averages > 99% in the UVB range of 280nm - 315nm and >77% in the UVA range of 316 - 380mm.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 65% water by weight. The lenses will be manufactured in spherical, aspherical, toric, and multifocal configurations with the following features and properties.

The provided text describes the Intelliwave4 contact lens and its substantial equivalence to a predicate device, IntelliWave3. It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This type of regulatory submission does not typically involve detailed acceptance criteria tables or studies designed to "prove" a device meets acceptance criteria in the way a novel device might. Instead, it relies on demonstrating equivalence through comparison of design, materials, and clinical performance.

However, based on the information provided, I can extract the closest parallels to your requested categories:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for specific performance metrics in a table. Instead, it compares the new device (Intelliwave4) to a predicate device (IntelliWave3) to demonstrate substantial equivalence. The "performance" is described in terms of safety and efficacy being "similar overall performance" to the predicate.

Here's a table reflecting the comparative properties and a summary of performance as reported:

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

• Test set sample size: 60 patients
• Data provenance: Not explicitly stated regarding country of origin, but the study was a "bilateral, open-label, parallel group, and randomized daily wear study" which indicates a prospective design. Given the FDA submission, it implicitly refers to data relevant for US regulatory purposes, likely with US or internationally recognized standards.

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)

This information is not provided in the document. The clinical study details are very brief. It mentions "Clinical evaluation demonstrated similar overall performance," but it does not specify the number or qualifications of clinicians involved in assessing "vision, health, and comfort and fit."

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

This information is not provided in the document.

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

This is not applicable. The device is a contact lens, not an AI-assisted diagnostic tool. The clinical study compares the new contact lens to a predicate contact lens.

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

This is not applicable. The device is a contact lens.

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

The "ground truth" for the clinical study was the clinical evaluation of 60 patients over three months, assessing "vision, health, and comfort and fit." This falls under outcomes data or clinical assessments by potentially multiple clinicians, although the specific number and qualifications are not detailed.

8. The sample size for the training set

This is not applicable in the context of this device. A training set is typically for machine learning algorithms. The Intelliwave4 contact lens is a physical medical device. The "training" for its development would involve material science, engineering, and manufacturing, not a data-based training set.

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

This is not applicable for the reasons stated in point 8.

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