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510(k) Data Aggregation
(43 days)
The Toricolors (hioxifilcon D) Soft Contact Lenses for daily wear (power range -12.00D to +6.00D) is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Not Found
The provided document is a 510(k) premarket notification letter for a medical device (PolyDev Soft Contact Lenses). It is not a study report and therefore does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, or device performance against those criteria.
The letter acknowledges receipt of the 510(k) submission and states that the device is substantially equivalent to legally marketed predicate devices. It also includes an "Indications for Use" statement, defining what the device is intended for.
Therefore, I cannot provide the requested information based on the provided text.
To answer your questions, I would need a study report or clinical trial summary that details the performance testing conducted for the PolyDev Soft Contact Lenses. This document only provides the regulatory approval letter.
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(90 days)
The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 1.25 Diopters.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Not Found
I am sorry, but based on the provided document, I cannot identify any information regarding acceptance criteria, device performance results, or details about a study that would include sample sizes, ground truth establishment, or expert qualifications.
The document is an FDA 510(k) clearance letter for "Toricolors (hioxifilcon D) Soft Contact Lenses," confirming its substantial equivalence to a legally marketed predicate device. It primarily discusses regulatory classifications, general controls, and compliance requirements. It also includes an "Indications for Use" section.
There is no mention of a clinical study, performance metrics, or statistical analysis that would typically be associated with proving a device meets specific acceptance criteria.
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(97 days)
The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. Eye care practitioners may prescribe the lens for frequent/ planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Not Found
This document is an FDA 510(k) clearance letter for a medical device: "Toricolors (hioxifilcon D) Soft Contact Lenses". It states that the device is substantially equivalent to a predicate device. However, this document does not contain any information regarding the acceptance criteria, the study details proving the device meets those criteria, or clinical performance data.
Therefore, I cannot provide the requested information based on the input text. The text only confirms the FDA's regulatory decision regarding market clearance, not the technical study details usually found in a premarket submission summary.
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