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510(k) Data Aggregation
(198 days)
The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professionals should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Soft (hydrophilic) contact lens
This document is an FDA 510(k) clearance letter for cosmetic contact lenses. It does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy.
The provided text is a regulatory approval document for a medical device (contact lenses) based on substantial equivalence to a predicate device. It confirms that the device can be marketed. It does not include:
- A table of acceptance criteria and reported device performance (in the context of analytical or clinical performance of a diagnostic or AI device).
- Information about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance.
- The type of ground truth used to evaluate performance.
- Details about a training set or how its ground truth was established.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies proving device performance, as the provided text relates to the regulatory approval of contact lenses, not a diagnostic or AI-driven device with such performance metrics.
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(318 days)
The FreshKon® (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be used to enhance or alter the apparent color of the eye. The lenses may be disinfected using a chemical disinfection system.
Not Found
The provided text is an FDA 510(k) clearance letter for various FreshKon® contact lenses. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically found in a clinical study report or a 510(k) summary (which might include a section on performance data).
The document is a legal notification of substantial equivalence for a medical device, based on the comparison to a legally marketed predicate device. It confirms that the reviewed device is deemed substantially equivalent in terms of safety and effectiveness for its stated indications for use.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance evaluation, including sample sizes, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance, because this information is not present in the provided text.
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