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

Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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 Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.

The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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.

OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.

This document is a 510(k) summary for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device testing (e.g., sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies) is not applicable to this document.

However, I can extract information related to the device attributes and the comparisons made to establish equivalence, which can be seen as meeting "acceptance criteria" for chemical/physical properties rather than AI performance.

Here's a breakdown of what can be inferred and what is explicitly stated:

Acceptance Criteria and Device Performance (Analogous for Contact Lenses)

In the context of contact lenses, "acceptance criteria" are not thresholds for AI performance, but rather specifications and physical/chemical properties that demonstrate the new devices (Vexillum Zephyr and OxyPure A) are substantially equivalent to the predicate device (OxyPure Color). The table below summarizes these comparisons.

Study Proving Device Meets Criteria:

The study proving the devices meet the "acceptance criteria" (i.e., are substantially equivalent) is based on non-clinical bench testing and comparison of technical characteristics to the predicate device.

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of AI. The "test" consists of various physical, chemical, and mechanical tests on the contact lenses. The specific number of lenses tested for each parameter (e.g., tensile strength, oxygen permeability) is not provided in this summary but is implied to be sufficient for standard quality control and regulatory submission.
   • Data Provenance: The document does not specify the country of origin for the testing data, but the applicant's address is Taiwan. The studies are non-clinical bench tests, implying they are laboratory-based, not patient-based data. They are presumably prospective in the sense that they were specifically conducted for this submission.

2. Number of Experts and Qualifications for Ground Truth:

   • Not Applicable. This document is not evaluating AI performance or subjective diagnostic interpretations. Ground truth, in this context, refers to the objective measurements of the lens properties themselves, assessed through established laboratory procedures according to recognized ISO and ASTM standards. No human expert "ground truth" establishment in the diagnostic sense is mentioned.

3. Adjudication Method for Test Set:

   • Not Applicable. As there are no human-in-the-loop diagnostic interpretations requiring adjudication, this concept does not apply.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. The document explicitly states: "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." This confirms that no clinical studies, including MRMC studies, were conducted.

5. Standalone Performance (Algorithm Only):

   • Not Applicable. This is not an AI device.

6. Type of Ground Truth Used:

   • For the physical and chemical properties, the "ground truth" is established through objective laboratory measurements following recognized international standards (ISO, ASTM). Examples include:
     • Spectrophotometry for UV transmission.
     • Fatt method for oxygen permeability.
     • Standardized tests for tensile strength, modulus, elongation, and toughness.
     • Biocompatibility testing as per ISO 10993 series.
     • Sterility testing.
   • For the overall determination of substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device (OxyPure Color Silicone Hydrogel Soft Contact Lenses, K171447). The new devices are compared to this established benchmark.

7. Sample Size for Training Set & How Ground Truth for Training Set was Established:

   • Not Applicable. There is no training set as this is not an AI/machine learning device. The entire process relies on direct measurement and comparison to a known good (predicate) device, and adherence to established industry standards.

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