(131 days)
The OxySoft (olifilcon C) Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The OxySoft (olifileon C) 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 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The OxySoft (olifilcon C) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with nondiseased 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 OxySoft (olifilcon C) 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 46% olifilcon C and 54 % 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 1.9% (
The provided document is a 510(k) premarket notification for a soft contact lens called OxySoft (olifilcon C). It does not describe an AI medical device. Therefore, a response matching the format of an AI device's acceptance criteria and study cannot be generated. However, I can summarize the information provided regarding the clinical study conducted for the contact lens.
Here's a summary of the clinical study for the OxySoft (olifilcon C) silicone hydrogel soft contact lens:
Clinical Study for OxySoft (olifilcon C) Silicone Hydrogel Soft Contact Lens
1. Acceptance Criteria and Reported Device Performance (as inferred from the summary):
The document does not explicitly state quantitative acceptance criteria for device performance in the same way an AI device would have specific metrics (e.g., sensitivity, specificity). Instead, the study aimed to demonstrate safety and effectiveness by comparison to a predicate device, focusing on:
| Metric | Desired Outcome (Inferred Acceptance) | Reported Performance |
|---|---|---|
| Safety | No significant adverse events or findings requiring treatment. | - No adverse event (AE) occurred in the study. |
- No symptom or syndrome requiring treatment for all subjects during the study period.
- No significant slit lamp findings (i.e., Grade 3 or Grade 4) were found. |
| Effectiveness (Visual Acuity) | Visual acuity comparable to the predicate device and correctable to 0.1 LogMAR or better. | - The mean visual acuity (VA) for both lenses (OxySoft and predicate Si-Hy) was similar at each visit. - Visual acuity could be corrected to 0.1 LogMAR or better for all subjects.
- None of the subjects had VA decreased more than 2 lines. |
| Wear Time | Safe for daily wear up to 9 hours a day for 30 days. | Found safe for daily disposable single use, worn up to 9 hours a day during 30 days follow-up. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: 36 subjects were enrolled.
- Trial group (OxySoft): 24 subjects
- Control group (Si-Hy predicate): 12 subjects
- Data Provenance: The document states, "All of them are Asia people." This suggests the data was collected in an Asian population, likely Taiwan, given the manufacturer's location. The study was prospective.
3. Number of Experts and Qualifications for Ground Truth:
- This information is not provided in the document. For contact lens studies, "ground truth" usually refers to clinical measurements (visual acuity, slit lamp evaluations by optometrists/ophthalmologists) rather than expert consensus on images. The clinical evaluations were likely performed by the study investigators or their staff.
4. Adjudication Method for the Test Set:
- This information is not provided in the document. Clinical trials typically have protocols for handling discrepancies in measurements or adverse events, but a specific "adjudication method" in the context of expert review for ground truth (as relevant to AI) is not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study model is generally used for diagnostic devices that involve human interpretation of images, often with AI assistance. This document describes a clinical study for a physical medical device (contact lens).
6. Standalone (Algorithm Only) Performance:
- No, this is not applicable. The device is a physical contact lens, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for this study was established through a combination of clinical measurements and observations by healthcare professionals. This included:
- Visual acuities
- Slit lamp findings (e.g., for corneal health, lens fit)
- Subjective symptoms, problems, and complaints (patient-reported outcomes)
- Adverse reactions
8. Sample Size for the Training Set:
- This is not applicable. The study describes a clinical trial for a physical medical device, not an AI model that requires a "training set."
9. How Ground Truth for the Training Set Was Established:
- This is not applicable as there is no AI training set.
§ 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.