Search Results

The Vexillum (olifilcon B) with Tangible Polymers Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Vexillum (olifilcon B) with Tangible Polymers Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Vexillum (olifilcon B) with Tangible Polymers Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Daily Breeze (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The Daily Breeze (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Daily Breeze (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.

The Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.

The provided document discusses the 510(k) premarket notification for two soft contact lenses: Vexillum (olifilcon B) with Tangible Polymers and Daily Breeze (olifilcon B). It asserts substantial equivalence to a predicate device (Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lenses, K160344).

It is important to note that this document does not describe a study involving an AI/Machine Learning device. It pertains to contact lenses and their physical/chemical properties. Therefore, many of the requested criteria (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through non-clinical bench testing and comparisons of material, design, and performance characteristics.

Here's an attempt to answer the applicable parts of your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the format of a typical AI/ML study (e.g., target specificity and sensitivity values). Instead, it demonstrates "substantial equivalence" by comparing various parameters of the new devices (Vexillum and Daily Breeze) against a legally marketed predicate device (Si-Hy, K160344). The acceptance criterion, implicitly, is that the new devices are "substantially equivalent" to the predicate in terms of their intended use, technological characteristics, and performance characteristics, and that any differences do not raise new questions of safety or effectiveness.

Here's a table summarizing the comparison parameters and their reported performance/characteristics, which effectively serve as the "acceptance criteria" for substantial equivalence in this context:

The crucial acceptance here is based on the conclusion that while differences exist in "Packaging Solution" and "Coating on the lens surface" for Vexillum, these differences "do not raise any new questions of safety or effectiveness."

Study Proving Device Meets Acceptance Criteria:

The study used to prove the device meets these "acceptance criteria" is a non-clinical bench testing and comparative study against a predicate device.

2. Sample size used for the test set and the data provenance:

   • The document does not specify exact sample sizes for each bench test. However, it indicates that "bench tests were performed in accordance with following FDA Recognized Consensus Standards." These standards (e.g., ISO and ASTM) dictate the required sample sizes for specific tests.
   • Data Provenance: The company is Visco Vision Inc., located in Taoyuan City, TAIWAN. The studies would have been conducted by them or their contracted labs. This is a premarket submission, so it's prospective in the sense of demonstrating performance for a new device, but the tests themselves follow established methodologies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is a physical device (contact lens), not an AI/ML diagnostic system requiring expert interpretation of medical images. "Ground truth" is established through standardized laboratory measurement techniques (e.g., spectrophotometry for UV transmission, tensile strength testing, chemical analysis for leachables). The "experts" are the lab technicians and scientists performing these tests according to recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. As above, this is for physical/chemical testing, not for subjective interpretation of data requiring adjudication. Compliance with a standard means the results fall within defined tolerances.

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/ML device, nor does it involve human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is not an AI/ML device. The "standalone" performance here refers to the physical and chemical properties of the contact lens itself as measured in a lab setting (e.g., water content, oxygen permeability).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance of these contact lenses is established through standardized physical, chemical, and biological test methods (bench tests) as defined by international standards (e.g., ISO, ASTM). These methods are designed to objectively measure properties like oxygen permeability, water content, tensile strength, sterility, and biocompatibility. The predicate device's performance also serves as a "ground truth" benchmark for comparison.

8. The sample size for the training set:

   • Not Applicable. This isn't an AI/ML device, so there is no "training set." The development of the contact lens material (olifilcon B) and manufacturing processes would involve research and development, but not in the sense of "training data" for a machine learning model.

9. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Ask a specific question about this device