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Prosthetic (polymacon) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearence of lanses which are designed to fit over the corneal surface of the lenses are made by modifying the uncolored polymacon cast molded lens by affixing a colored pigment on that portion of the front surface that corresponds to the iris. The colored pigments consist of: carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide black, phthalocyanine blue and titanium dioxide. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopla (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power that is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

The provided text describes a 510(k) submission for a Prosthetic (polymacon) Hydrophilic Contact Lens for Daily Wear. This document focuses on the substantial equivalence of the new device to a predicate device and its performance testing related to toxicology and material properties. It does not contain information about acceptance criteria and studies in the context of AI/ML device performance metrics like sensitivity, specificity, or reader studies.

Therefore, the following points cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: The document does not specify acceptance criteria in terms of accuracy metrics (e.g., sensitivity, specificity, AUC) or numerical performance results for such metrics. It states the results of toxicology testing were "non toxic" and that "respective extracts did not contain leachable color or significant levels of residual monomers," but these are qualitative statements, not quantitative performance metrics against defined acceptance criteria typically seen in AI/ML device evaluations.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set as understood in AI/ML context is described. The "Performance Testing of Contact Lens" mentions "lenses were loaded with the following eleven pigments," but this refers to the components of the product itself for toxicology and leachability testing, not a dataset for evaluating an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not described. The document is about the material equivalence and safety of a physical contact lens.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm described.
7. The type of ground truth used: For toxicology and leachability, the "ground truth" would be the standard laboratory assays and their established thresholds for toxicity and chemical detection. However, this is not a ground truth for diagnostic or prognostic performance as would be relevant for an AI/ML device.
8. The sample size for the training set: Not applicable, as no training set for an AI/ML model is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance (based on provided text):

The document states:

• "The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens is non toxic."
• "Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color or significant levels of residual monomers."
• The physical, optical, and chemical properties are "equivalent to those of the FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect Vision Care, Ltd." because the base lens is the same.

In conclusion, the provided text describes the regulatory submission for a physical medical device (contact lens) and not an AI/ML-driven device. Therefore, the questions related to AI/ML device acceptance criteria, study design, and performance metrics cannot be answered from this document.

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The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) is 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 2.00 Diopters that does not interfere with visual acuity. These lenses may be used to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. The lenses are made by modifying the uncolored methafilcon A cast molded lens by affixing a colored pigment on that the unoolorod from hamsee that corresponds to the iris. The colored pigments consist of portion on the from oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine phinalobyanino groom, we . These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power that is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

This 510(k) submission describes the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted). The submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo performance studies with separate acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission primarily demonstrating substantial equivalence to an existing predicate device, explicit acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity for a diagnostic device) are not presented in the same way they would be for a novel device. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new device's properties are equivalent to the predicate device, which is presumed to have already met necessary safety and effectiveness standards.

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

The document describes performance testing related to toxicology and leachability, but it doesn't specify a "test set sample size" in the context of comparative clinical performance against human readers or standalone diagnostic accuracy.

• Toxicology and Color Leachability: Lenses were loaded with eleven specified pigments and tested for cytotoxicity, acute systemic toxicity, acute ocular irritation, residual monomer, and color leachability.
  • Sample Size: Not explicitly stated in terms of number of lenses or subjects. The phrasing "The results of toxicology testing...have demonstrated" and "the results of residual monomer and color leachability testing demonstrate" implies a study was conducted, but the specifics of the sample size are absent.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

For the claim of substantial equivalence regarding physical, optical, and chemical properties, the "sample" is essentially the design and manufacturing specifications of the new device being compared to the predicate. The document states: "The physical, optical, and chemical properties of the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)) are equivalent to those of the FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect Vision Care, Ltd. since this lens is provided to CL-TINTERS by Aspect Vision Care, Ltd." This suggests an inherent equivalence due to shared manufacturing/supplier, rather than a separate, large-scale comparative study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable to this 510(k) submission. The device is a contact lens, not an AI diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for contact lens performance typically involves engineering specifications, material science testing, and clinical safety/tolerance studies.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "test set" in the context of human interpretation or diagnostic decision-making to require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating observer performance, particularly in diagnostic imaging, which is not relevant to a contact lens.

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

No, a standalone performance study in the context of an "algorithm" is not applicable. This device is a physical medical device (contact lens), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Material Science and Engineering Specifications: The chemical composition (methafilcon A, HEMA, EGDMA), physical dimensions, optical power, water content, and other parameters that define the lens.
• Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is that the new device's properties (physical, optical, chemical) and indications for use are "substantially equivalent" to a legally marketed predicate device (Aspect Vision Care, Ltd.'s FREQUENCY 55).
• Toxicology and Leachability Testing: Lab-based tests demonstrating non-toxicity and non-leachability of color additives/monomers.
• FDA Guidance: Compliance with established FDA guidance for daily wear contact lenses (e.g., being a Group 4, ionic, high water content polymer).

8. The Sample Size for the Training Set

This information is not applicable. Contact lenses do not utilize "training sets" in the context of AI or machine learning algorithms.

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

This information is not applicable for the same reason as point 8.

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