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

The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves 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 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic 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 Intelliwave4 with HPT, 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 characterized by high water content. The lens material is composed of silicone monomers cross linked with other monomers, and it optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom Ry. 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).

The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are 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 (safrofilcon A) is completely encapsulated in a thin layer of polymer that results in measurable improvement of the surface characteristics, compared to untreated lenses, including: wettability (dynamic contact receding angle), lubricity (coefficient of friction), and water film stability (WBUT). The resulting layer is hydrophilic and approximately 30nm in thickness.

This document (K152046) is a 510(k) premarket notification for a new class II medical device, the Intelliwave4 with HPT (Hydra-PEG Technology) Silicone Hydrogel Daily Wear Soft Contact Lens. It is not an AI/ML medical device and therefore does not include the detailed information requested in the prompt regarding AI model performance, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (IntelliWave4, K142641) by showing that the addition of Hydra-PEG Technology (HPT) to the contact lens surface, while enhancing certain physical properties, does not change the core functionality, intended use, or safety profile of the device.

However, based on the provided document, I can extract and infer some information relevant to the concept of acceptance criteria and the study that proves the device meets them, specifically concerning the physical and material properties, and clinical performance for equivalence.

Here's an attempt to structure the information based on your prompt, acknowledging the limitations due to the nature of the document:

Device: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

This device is not an AI/ML driven diagnostic or assistive tool, but rather a physical medical device (contact lens). Therefore, many of the specific criteria related to AI performance, such as MRMC studies, expert adjudication for ground truth of an algorithm, and effect sizes of AI assistance, are not applicable here. The "acceptance criteria" discussed are related to the physical properties, safety, and effectiveness of a contact lens compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds in the same way an AI model might have for metrics like AUC or sensitivity/specificity. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device, particularly that the new HPT treatment does not negatively impact safety or core performance, and ideally improves certain physical properties of the lens surface.

The table below summarizes the enhanced surface properties of the new device compared to the predicate device, which implicitly serve as a form of "performance acceptance" in the context of demonstrating improvement while maintaining safety. Clinical performance is evaluated for "similar overall performance."

Note: The "acceptance criteria" for improved properties are implicitly that the new device performs significantly better than the predicate for beneficial characteristics, and for other properties (like water content, oxygen permeability), the criterion is to be substantially equivalent.

2. Sample Size and Data Provenance for Test Set (Clinical Study)

• Sample Size for Test Set: 30 patients
• Data Provenance: The document does not specify the country of origin. It describes a "bilateral, open-label, parallel group, and randomized daily wear study." It is a prospective clinical study.

3. Number of Experts and Qualifications for Ground Truth

• Applicability for this device: Not directly applicable in the typical AI/ML sense of establishing ground truth for image interpretation or diagnosis.
• Context for this device: The clinical study evaluated safety and efficacy. The "experts" would be the eye care practitioners supervising the study and assessing clinical outcomes (vision, health, comfort, fit). The document does not specify the number or qualifications of these practitioners, but they would be licensed professionals involved in contact lens prescribing and care.

4. Adjudication Method for the Test Set

• Applicability for this device: Not explicitly stated as an adjudication method for a "test set" in the AI/ML context.
• Context for this device: The clinical study's design (open-label, parallel group, randomized) implies standard clinical trial methodology for data collection and analysis to ensure unbiased assessment of patient outcomes. Decisions on "ground truth" (e.g., whether a lens fits well, or whether vision is adequate) would be made by the trained clinicians participating in the study as part of their standard practice.

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

• Was an MRMC study done? No. This type of study is specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance

• Applicability for this device: Not applicable. This device is a physical contact lens, not a software algorithm. Its "performance" is inherent in its physical and material properties, and its clinical performance when worn by a human.

7. Type of Ground Truth Used

• For physical/material properties: Quantitative measurements derived from in vitro tests (e.g., contact angle, friction, WBUT, water content, oxygen permeability). These are objective measurements from laboratory equipment.
• For clinical safety and effectiveness: Patient-reported outcomes (comfort), clinician assessments (vision, health, fit), and observations during a clinical study. This is essentially outcomes data and clinical assessment.

8. Sample Size for the Training Set

• Applicability for this device: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense.
• Context for this device: The device development would involve R&D, material science, and manufacturing process development, but not a "training set" as understood for AI.

9. How Ground Truth for the Training Set Was Established

• Applicability for this device: Not applicable for an AI/ML context.
• Context for this device: For physical and material properties, the "ground truth" for development and manufacturing is established through standard laboratory testing methods and material science principles, ensuring the lens meets specified manufacturing tolerances and material compositions. For safety and biocompatibility, this is established through pre-clinical toxicology and biocompatibility tests conducted according to GLP regulations.

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