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The COLORSOFT. Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eve color. The COLORSOFT visitint provides for ease of patient handling and does not effect iris color.

Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer's recommendation.

COLORSOFT. Color Enhanced Tinted Soft Contact Lens are color enhanced soft contact lenses 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 color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The COLORSOFT. Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Colorsoft Blue, Deep Blue, Aspen Green, Aquamarine, Yellow, Violet, Red, Chocolate, and Amber. COLORSOFT, Color Enhanced Tinted Soft Contact Lens are also available in a standard blue visibility-handling tint.

The 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 blue 21, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

The following are tint patterns available to the practitioner:

• Clear Pupil diameter (2,00mm to 8,00mm), standard is 4,5mm.
• Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter.
• -Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter.

The provided text is a 510(k) summary for the COLORSOFT Color Enhanced Tinted Soft Contact lens. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel medical device with entirely new performance claims.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table with performance metrics that the COLORSOFT device met. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device, the DURASOFT 2 COLORS tinted soft contact lens. The "performance" is implicitly assumed to be equivalent to the predicate device, as the COLORSOFT lenses are essentially existing soft contact lenses enhanced with color using FDA-listed additives.

The table presented (Table #1 - Substantial Equivalence) highlights the similarities and differences between the COLORSOFT device and the predicate in terms of intended use, indications, actions, FDA "listed" colored additives, color additive characteristics, and colors offered. It doesn't present a set of quantitative performance metrics for "acceptance criteria" against which the COLORSOFT device was specifically tested and reported for safety and effectiveness in an independent study within this document. The argument is that because the core lens properties remain unchanged (except for light transmittance due to tinting), and the color additives are previously FDA-listed and well-established, the device is inherently safe and effective in the same manner as the predicate.

Information Not Found in the Provided Text:

The nature of this 510(k) submission, which focuses on substantial equivalence rather than a de novo approval with new performance claims, means that much of the requested information regarding detailed study design (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training data) is not present in the provided document.

Here's why and what's missing:

• No explicit "acceptance criteria" table with reported performance: The submission's "acceptance criteria" are effectively the characteristics of the predicate device.
• No specific study proving the device meets acceptance criteria: The provided document does not describe a new, independent study designed to prove the COLORSOFT device meets new performance criteria beyond what is already accepted for tinted contact lenses using FDA-approved color additives. The substantial equivalence argument is the "study."

Summary of Requested Information Based on Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance:

   Feature/Characteristic	Colorsoft Laboratories ("COLORSOFT")	Predicate Device (Durasoft 2 Colors)	Acceptance Criteria (Implicit)
   Intended Use	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens	Equivalent to predicate
   Indication	Enhance/alter apparent eye color; ease of handling; no effect on iris color; disinfected per original manufacturer's instructions.	Enhance/alter apparent eye color, including ocular masking.	Equivalent to predicate
   Actions	Refracting medium to focus light rays on retina.	Refracting medium to focus light rays on retina.	Equivalent to predicate
   FDA "listed" colored additives	Reactive black 5, reactive blue 4, reactive blue 19, reactive 21, reactive blue 163, reactive yellow 15, reactive yellow 86, reactive orange 78, reactive red 11 and reactive red 180.	Iron oxides, chromium oxide greens, titanium dioxide, [phthalo-cyaninato (2-)] copper carbazole violet and phthalocyanine green.	Use FDA-listed color additives in minimum reasonable amounts.
   Uses and restrictions (Additives)	Amounts not to exceed minimum reasonably required for intended coloring effect.	Amounts not to exceed minimum reasonably required for intended coloring effect.	Equivalent to predicate
   Color Additive Characteristics	Not removed by lens handling/cleaning. Optical and performance characteristics not altered by coloring process (except light transmittance).	Not removed by lens handling/cleaning. Optical and performance characteristics not altered by coloring process.	Equivalent to predicate
   Colors Offered	Colorsoft Blue, Deep blue, Aspen Green, Jade, Aquamarine, Yellow, Violet, Red, Chocolate, and Amber.	Sky blue, Jade green, Aquamarine and Violet blue.	Not directly comparable, but both offer various colors. Acceptable that specific colors differ as long as process/additives are safe.

   Note: The "acceptance criteria" are implicitly met by demonstrating that the COLORSOFT device is substantially equivalent to the predicate device across these characteristics.

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

   • Not explicitly stated. The document does not describe a clinical "test set" in the context of a new performance study. The substantial equivalence argument relies on the established safety and efficacy of the predicate device and the FDA-listed color additives.

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):

   • Not applicable/Not stated. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic accuracy). This submission doesn't detail such a study.

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

   • Not applicable/Not stated. See point 3.

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:

   • Not applicable. This device is a colored contact lens, not an AI or diagnostic imaging device that would involve human "readers" or AI assistance.

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

   • Not applicable. This device is a physical medical device, not a software algorithm.

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

   • Implicitly, regulatory compliance and prior FDA approvals. The "ground truth" for the safety and effectiveness claims relies on:
     • The fact that the base contact lens (pre-tinted) was already approved and prescribed.
     • The color additives used are "FDA 'listed'" as safe for contact lenses.
     • The manufacturing process ensures thorough washing to remove unbound additives.
     • The process does not alter original lens characteristics (except light transmittance).
     • The predicate device has established safety and efficacy.

8. The sample size for the training set:

   • Not applicable/Not stated. There is no "training set" in the context of machine learning or a de novo clinical trial described in this document.

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

   • Not applicable/Not stated. See point 8.

Conclusion:

The provided document is a 510(k) summary demonstrating substantial equivalence for the COLORSOFT colored contact lenses. It does not contain information about a new clinical study with specific acceptance criteria, test sets, expert ground truth establishment, or AI-related metrics as would be found for novel diagnostic or AI-powered devices. The "study" here is the comparative analysis against an already approved predicate device and reliance on the FDA-listed status of the color additives.

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