(96 days)
The OxyAqua (olifilcon D) Spherical Silicone Hydrogel soft (hydrophilic) contact lenses are daily wear single use soft contact lens indicated for the corrective 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 OxyAqua (olifilcon D) Toric Silicone Hydrogel Soft (hydrophilic) 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 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The OxyAqua (olifilcon D) Multifocal Silicone Hydrogel Soft (hydrophilic) Contact lenses are indicated as daily wear for the correction of ametropia (myopia) 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 OxyAqua (olifilcon D) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 42% olifilcon D and 58 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.4% (
The document describes the premarket notification for a new soft contact lens, the "OxyAqua (olifilcon D) silicone hydrogel soft contact lens," seeking substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and supporting study:
The provided document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a way that is typically found in a clinical trial report for software. However, the regulatory submission for the OxyAqua contact lenses implicitly relies on demonstrating that the device is "as safe, as effective, and performs as well as the predicate device."
Here's an interpretation of the implied acceptance criteria and reported device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (OxyAqua - Olifilcon D) |
|---|---|
| Safety | |
| Biocompatibility (non-toxic in ocular environment) | Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment. |
| Absence of new or increased adverse reactions | Clinical study found no significant adverse reactions reported or Grade 3 or Grade 4 slit lamp findings. No significant differences in slit-lamp findings were found between groups (OxyAqua vs. Predicate). |
| Acceptable Slit Lamp Findings | No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups. |
| Effectiveness/Performance | |
| Visual Acuity correction (for ametropia/presbyopia) | Mean VA for both lenses (OxyAqua and Predicate) was similar at each visit. Visual acuity could be corrected to 0.1 (log MAR) or better in the clinical study. |
| Lens Wearing Time (acceptable daily wear) | Clinical study included lens wearing time as a parameter, and participants wore the lenses on a daily wear basis, demonstrating acceptable wearing time (though specific duration not explicitly stated as a result). |
| Physiochemical properties within established specifications | Physiochemical studies were conducted according to ISO 18369. The physical, optical, and chemical properties of the lens are within established specifications for the lenses. |
| Substantial Equivalence to Predicate | |
| Overall similarity "as safe" and "as effective" as predicate | "Comparison to the predicate device for chemical composition, physical and optical properties, it shows that 'OxyAqua silicone hydrogel soft contact lens' is as safe, as effective and performs as well as the predicate device." |
| Matching Indications for Use | The indications for use for OxyAqua (Spherical, Toric, Multifocal) are clearly defined for correction of ametropia, astigmatism, and presbyopia in non-diseased eyes, for daily wear and single use, aligning with the type of conditions typically addressed by soft contact lenses and, by implication, those addressed by the predicate. |
| Similar Technological Characteristics (despite material change) | Despite material difference (Olifilcon D vs B, 58% vs 47% water content, Dk 85 vs 120), other characteristics like diameter, base curve, center thickness, powers, refractive index, light transmittance, handling tint, and manufacturing method are presented as similar or within acceptable ranges for substantial equivalence. The predicate device shared the same manufacturer and product code (MVN), implying a similar regulatory and safety profile as a daily disposable soft contact lens. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "At least 30 evaluable subjects were participated."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of "a three-month clinical study" strongly suggests it was a prospective study conducted to specifically support this submission. The manufacturer is based in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for contact lens clinical trials in the same way it is for AI/computer vision devices. Ground truth for contact lenses is established through direct clinical observations and measurements by eye care professionals (e.g., ophthalmologists, optometrists) during the study visits. The document does not specify the number or qualifications of these clinical professionals, but it can be inferred that appropriately qualified clinicians would have performed the evaluations as part of a "clinical study."
4. Adjudication Method for the Test Set
Not specified. Clinical studies for contact lenses typically involve direct observation and measurement by qualified eye care practitioners. There is no mention of a separate adjudication process by experts, as common in AI device evaluations where multiple readers interpret images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not done. MRMC studies are typically performed to evaluate the diagnostic performance of a new system (often AI-based) by comparing reader interpretations with and without the system's aid. This study compared two contact lenses (OxyAqua vs. an existing predicate) in a clinical trial setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical device (contact lens), not an AI algorithm. Its performance is inherent to the lens itself when worn by a human.
7. The Type of Ground Truth Used
The ground truth was established through clinical observations and measurements (e.g., visual acuity, slit-lamp findings, adverse event reporting) by clinicians during a prospective clinical study directly on human subjects. This is considered direct clinical evidence.
8. The Sample Size for the Training Set
This question is not applicable. The device is a manufactured physical product (contact lens), not a machine learning model that requires a training set. The "study" refers to the clinical trial conducted for regulatory submission, not machine learning model development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.