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The Dream Color I, II, and III (polymacon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.50 diopters that does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eves. Eyecare practitioners may prescribe 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

Dream soft contact lenses are hemispherical shape with molded spherical base curves and lathe-cut front surfaces. Its' sectional configuration has symmetrical shape. Back-cover surface except optic zone and edge side is colored with various colors. The lenses are made of hydrophilic polymer of 2-Hydroxyethyl methacrylate(HEMA) and cross-linked with ethylene glycol dimethacrylate(EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Iron Oxides, C.I. Pigment Green 7, (Phthalocyaninato(2-)) Copper and Reactive Black 5. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only amount of color additive need to accomplish the intended coloring effect. in hydrated state. the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming colored optical surface. The hydrophilic properties of the lens require that it is maintained in a fully hydrated state in a solution compatible with the eye. If the lens dry 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 document describes a 510(k) premarket notification for "Dream Color I, II, and III (polymacon) Soft (hydrophilic) Contact Lenses." The acceptance criteria and the study conducted are primarily focused on demonstrating substantial equivalence to a predicate device ("Migwang Comfort 38") and compliance with biocompatibility and manufacturing standards rather than a comparative effectiveness study of the device's main function (vision correction).

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the physical properties and performance characteristics presented, demonstrating equivalence to the predicate device and adherence to established standards.

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

The document does not explicitly state the sample sizes for the "test sets" in terms of clinical trials or performance evaluations with human subjects for refractive correction. The testing mentioned primarily refers to bench testing, physicochemical analysis, and biocompatibility studies.

• For Biocompatibility: Tests were performed on "Dream Color I & II." No specific number of test samples (e.g., animals tested for irritation/sensitization) is listed, nor is the country of origin of the data explicitly stated beyond the submitting company's location in Korea. The studies are assumed to be prospective as they represent direct testing of the device for regulatory submission.
• Physicochemical Tests: "Dream Color I" and "Dream Color II - (Aqua, Blue)" are mentioned in specific test reports (e.g., MD 2007-035, MD 2008-033, MD 2007-036, MD 2008-034, MD 2011-033). The sample size for these manufacturing/quality control type tests is not provided, but these are typically performed on a representative batch or subset of manufactured devices. The data provenance is implied to be from the manufacturer's testing in Korea.

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

This information is not provided. The document focuses on demonstrating physical and chemical equivalence and biocompatibility, which rely on established scientific methods and standards (e.g., ISO 10993-1), rather than expert interpretation of medical images or diagnostic outputs.

4. Adjudication Method for the Test Set

Not applicable. The identified studies are not clinical trials or diagnostic performance studies requiring adjudication of outcomes by multiple experts.

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

No. An MRMC comparative effectiveness study was not performed. This device is a contact lens, and its primary function (vision correction) is evaluated against a prescription and standard clinical methods, not through an AI or diagnostic imaging system that would involve multiple readers or cases in that context. The submission focuses on product safety and equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The ground truth used for this submission is primarily established scientific standards, physical and chemical properties, and biological safety criteria.

• For physical properties (e.g., water content, refractive index, oxygen permeability, dimensions), the ground truth is the measured values of the device compared against the predicate device's specifications and industry standards.
• For biocompatibility, the ground truth is the pass/fail criteria established by consensus standards like ISO 10993-1.
• For indications for use, the ground truth is the accepted medical definitions of ametropia, aphakia, astigmatism, and daily/frequent wear.

8. Sample Size for the Training Set

Not applicable. This device is a contact lens. There is no "training set" in the context of machine learning or AI algorithms. The manufacturing process is validated, and the product characteristics are verified.

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

Not applicable. As there is no training set for an AI/algorithm, no ground truth was established in that context.

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