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The COLORSOFT PROSTHETIC Tinted Soft Contact lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as comeal, iris or lens abnormalities. The lens may also be prescribed for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical disinfection system only.

The COLORSOFT PROSTHETIC Tinted Soft Contact Lens are lens that have been previously prescribed for a specific patient. They have been supplied to Colorsoft Laboratories to be modified by a tinting process using color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The COLORSOFT PROSTHETIC contact lenses are tinted to the eyecare professional instructions. The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.

This 510(k) submission describes a new device, the COLORSOFT PROSTHETIC Tinted Soft Contact lens, and compares it to a predicate device, the Alden Classic Prosthetic Tinted Soft Contact Lens, to establish substantial equivalence. The document does not describe a study with acceptance criteria and device performance; instead, it outlines the device's characteristics and its intended use, asserting its equivalence to an existing product. Therefore, I cannot extract information about acceptance criteria, study sizes, expert qualifications, or ground truth details from this document.

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel clinical trial data with specific acceptance criteria and detailed performance metrics.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or details of a test set.
3. Information on the number or qualifications of experts to establish ground truth.
4. Details of an adjudication method.
5. Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Information on the type of ground truth used in a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document primarily focuses on:

• Device Identification: Name, applicant, classification.
• Substantial Equivalence Claim: Stating equivalence to predicate devices ("Alden Classic Prosthetic Tinted Soft Contact Lens" and "Colorsoft Laboratories COLORSOFT Color Enhanced Tinted Soft Contact Lens").
• Device Descriptive Characteristics: Materials, tinting process, available tint patterns.
• Indications for Use: Cosmetic management of conditions like corneal, iris, or lens abnormalities, and occlusive therapy.
• Comparison Table (Table #1 - Substantial Equivalence): This table directly compares characteristics of the COLORSOFT PROSTHETIC with the ALDEN CLASSIC PROSTHETIC and another Colorsoft product, highlighting similarities in intended use, indications, listed colored additives, and uses/restrictions. This comparison serves as the "study" for substantial equivalence, rather than a performance study against acceptance criteria.

The 510(k) clearance process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical performance studies with predefined acceptance criteria for a novel technology.

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