Search Results

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.

Ask a specific question about this device