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The ADVENTURE TINTS PROSTHETIC Tinted Soft Contact lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, 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 ADVENTURE TINTS PROSTHETIC Tinted Soft Contact Lenses are tinted with FDA "listed" color additives. 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 ADVENTURE TINTS 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 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 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.

Tint Patterns Available:

1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
2. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
3. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm increments.
4. Tinted Jens with Black Pupil. Uses the Adventure Tints tinted contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

The provided text is a 510(k) summary for the "ADVENTURE TINTS PROSTHETIC Tinted Soft Contact Lens", which is seeking substantial equivalence to existing predicate devices. The document does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in the way typically found for novel diagnostic algorithms or medical devices with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission demonstrates substantial equivalence based on a comparison of intended use, indications, and material characteristics with predicate devices. This type of device (tinted soft contact lens for prosthetic use) is not typically subject to performance studies involving sensitivity, specificity, or human-in-the-loop improvements because its primary function is cosmetic and occlusive, not diagnostic or therapeutic in a way that requires statistically demonstrated clinical effectiveness for novel claims.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's an attempt to answer based on the available information, noting where data is absent:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" for this device, as presented in the 510(k) summary, revolves around demonstrating substantial equivalence to predicate devices, particularly regarding safety and intended use. The performance metrics are descriptive rather than quantitative, focusing on the preservation of optical properties and the safety of the tinting process.

(No specific table of quantitative acceptance criteria and reported device performance from a study is provided in the document.)

The document effectively argues that the device's characteristics are substantially equivalent to the predicate devices, implying that their performance and safety profiles are also similar.

Detailed Study Information (Based on Available Text)

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit from Substantial Equivalence Comparison):
     • Intended Use: Cosmetic management of conditions such as corneal, iris, or lens abnormalities.
     • Indication for Use: Daily wear to enhance or alter eye color, including ocular masking, for cosmetic management of conditions like corneal/iris/lens abnormalities, or for occlusive therapy (diplopia, amblyopia, extreme photophobia). Disinfectable by chemical disinfection system only.
     • FDA "listed" colored additives: Use of specific reactive 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).
     • Uses and restrictions for color additives: Amounts not to exceed the minimum reasonably required, similar to predicate.
     • Color Additive Characteristics: Not removed by lens handling/cleaning/disinfecting, optical and performance characteristics are not altered by coloring process.
   • Reported Device Performance:
     • Matches the intended use and indications of the predicate devices.
     • Uses FDA "listed" color additives, albeit a different set than one predicate, but still within approved categories for contact lenses.
     • Conforms to restrictions on color additive usage.
     • "The color additives used are not removed by lens handling and approved cleaning/disinfecting procedures. The optical and performance characteristics are not altered by the lens coloring process." (Matches predicate).

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

   • Not Applicable. The submission does not describe a clinical performance study with a "test set" in the traditional sense of a study designed to quantify device performance with patient data. The substantial equivalence argument relies on comparing the device's design and materials to legally marketed predicate devices, and the inherent understanding of the performance of those predicate devices.

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. No ground truth establishment by experts for a specific test set is described.

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

   • Not Applicable. No adjudication method for a test set is described.

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 is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant to its substantial equivalence demonstration.

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.

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

   • Not Applicable, in the traditional sense. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, under the assumption that the new device's similar design and materials will yield comparable results.

8. The sample size for the training set:

   • Not Applicable. This is not a machine learning device and therefore does not have a training set.

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

   • Not Applicable. This is not a machine learning device.

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