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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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The ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The ADVENTURE TINTS 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 may be disinfected using a chemical disinfection system only.

ADVENTURE TINTS, 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 Adventure in Colors 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 ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Blue, Deep Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (Hot Pink), and Amber. ADVENTURE TINTS. 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 black 5. reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, 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. l
• Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter. -
• Occluder diameter (2.00mm to 12.5mm). a

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ADVENTURE TINTS, Color Enhanced Tinted Soft Contact lens:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed study results for device performance beyond a comparison to a predicate device. The information focuses on establishing substantial equivalence based on intended use, indications, actions, color additives, characteristics, and colors offered.

The closest we can come to "reported device performance" are the characteristics presented in the Substantial Equivalence table (Table #1), which essentially state the device meets the same characteristics as the predicate.

Crucially, the document explicitly states: "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." This statement indicates that no specific optical performance metrics beyond light transmittance were assessed or reported as changed. The primary focus is on the safety of the tinting process and the color additives.

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

The provided text does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission focuses on substantial equivalence to a predicate device based on descriptive characteristics and regulatory compliance of materials and processes.

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

This information is not provided in the document. No "ground truth" establishment by experts for a test set is described, as there is no mention of a clinical or performance study with human subjects or a defined test set that required expert evaluation.

4. Adjudication Method for the Test Set

As there is no mention of a test set or expert evaluation, there is no information about an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and The Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device is a tinted contact lens, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was done, and the concept of "human readers improving with AI" does not apply to this product.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

This device is a physical medical device (contact lens), not an algorithm or software. Therefore, no standalone "algorithm-only" performance study was done.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not describe a study involving "ground truth" as typically understood in the context of diagnostic device validation. The "ground truth" for this submission revolves around:

• Regulatory compliance: The listed color additives are FDA-approved for contact lenses.
• Material safety: The manufacturing process ensures unbound reactive color additives are removed.
• Equivalence to predicate: The assumption is that if the new device shares the same fundamental characteristics and uses approved materials/processes as a legally marketed predicate, it is safe and effective for its stated use.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant to machine learning or AI models. Since this is a physical medical device, there is no training set in that context.

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

As there is no training set, there is no information on how its "ground truth" was established.

Summary of Study Information:

The provided 510(k) summary is for a tinted contact lens where substantial equivalence is primarily established through a comparison of product characteristics, materials, and intended use to a legally marketed predicate device. It does not contain information about clinical trials, performance studies with human subjects, or any form of algorithmic testing. The "study" described is essentially a detailed comparison to a predicate device and a demonstration of compliance with relevant material safety and manufacturing regulations.

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