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Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D

Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.

Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) with presbyopia in aphakic or non-aphakic person with non-diseased eyes who may have +0.25D to +3.00D of ADD powers or less. The lens may be prescribed in spherical powers ranging from +6.00D to -12.25D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear and visibility tint with UV blocker are available as a spherical lens. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propyl-bis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and
Triallyl isocyanurate (TAIC) via photo-polymerization. The copolymer consists 50% Toufilcon B and 50% water by weight when immersed in buffered borate solution. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN).

This document describes the regulatory clearance of contact lenses, not a medical AI device requiring the kind of rigorous AI-specific validation outlined in your request. The provided text is a 510(k) clearance letter for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device through physicochemical, biocompatibility, and clinical performance in human subjects, rather than AI model performance metrics.

Therefore, many of the requested elements for an AI device's acceptance criteria and accompanying study (e.g., sample size for test set, data provenance for AI, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance, training set details) are not applicable to this document as it does not relate to an AI device.

However, I can extract the relevant information from the provided document concerning the contact lens study and present it in a similar structured format, adapting where necessary.

Device: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

Nature of Study: Clinical trial demonstrating substantial equivalence of a new contact lens product to an existing predicate device, focusing on safety and effectiveness for vision correction. This is not an AI device study.

1. Table of Acceptance Criteria (for Contact Lenses) and Reported Device Performance

Given this is a contact lens, the "acceptance criteria" are related to clinical efficacy (visual acuity) and safety (adverse events, slit lamp findings), and various physicochemical properties. The study aims to show non-inferiority or comparability to the predicate device rather than meeting specific numerical thresholds for many of the elements you'd expect in an AI performance table (e.g., sensitivity, specificity).

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

• Test Set Sample Size:
  • Screened: 75 subjects
  • Enrolled: 56 subjects (39 wore test lenses, 17 wore control lenses)
  • Completed Study: 54 subjects (2 subjects in test group discontinued)
• Data Provenance: Prospective, randomized, double-blind, parallel, active-controlled clinical trial conducted in Taiwan.

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

Not explicitly stated for establishing "ground truth," as this was a clinical trial involving patient outcomes and examinations. Clinical assessments were likely performed by eye care professionals involved in the study (e.g., ophthalmologists, optometrists), but a specific number or their detailed qualifications are not provided in the summary. The "ground truth" for contact lenses is physiological response, visual acuity, and safety outcomes from direct patient observation.

4. Adjudication Method for the Test Set

Not explicitly stated. Clinical trials typically have protocols for adverse event reporting and assessment, often by an independent safety committee or study investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is specifically designed for evaluating diagnostic performance of imaging modalities or AI systems where multiple readers interpret cases. This document describes a clinical trial for a contact lens, comparing direct patient outcomes between a new lens and a predicate.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

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

7. The Type of Ground Truth Used

The "ground truth" for this contact lens study was based on:

• Clinical Outcomes Data: Corrected visual acuity measurements.
• Safety Data: Adverse event reporting, assessment of slit lamp findings (direct observation of ocular health by clinicians).
• Physicochemical and Biocompatibility Test Results: Objective laboratory measurements demonstrating material properties and biological safety.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning study, so there is no training set in that context. The "training" for the device would be the manufacturing process and quality control.

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

Not Applicable. See point 8.

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