(69 days)
The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prostheric contact leases for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Spherical Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifileon B) Toric Soft Contact Leases for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.
The leases are available within a planned replacement program with frequency of replacement determined by the practitioner.
The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Contact Lens is fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A tint mixture containing; Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17 -Dimethoxydinaphtho [1.2.3 -cd:3'.2'.1' -lm] pervlene-5,10-dione, and Brown 16,23 -Dihydrodinaphtho [2,3-a.2 ] 3 ' -i] napth [2',3' ; 6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.
The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Tint Patterns Available:
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- Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
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- Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
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- Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
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- Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
The OXYLENS TINTED may contain a single listed color additive, or may contain a combination of color additives in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The color additives are added to the contact lens for enhancing and/or altering the apparent color of the eve.
In the hydrated state, the OXYLENS TINTED, PROSTHETIC lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a color altering optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided text is a 510(k) summary for the OXYLENS TINTED, PROSTHETIC (hioxifilcon B) Soft Daily Wear Contact Lens. This document demonstrates that the device is substantially equivalent to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested elements about acceptance criteria, clinical studies, sample sizes, ground truth, and expert involvement are not applicable as this type of submission relies on demonstrating substantial equivalence to existing devices with established safety and effectiveness.
Here's a breakdown of the applicable and non-applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
There are no explicit "acceptance criteria" presented in the format of a clinical study or performance goals that the device had to meet. The submission focuses on demonstrating substantial equivalence to predicate devices based on material characteristics and intended use. The table below summarizes the characteristics of the proposed device and its predicates, serving as the basis for the substantial equivalence claim.
Table of Device Characteristics and Predicate Comparison
| Characteristic | OXYLENS PROSTHETIC (hioxifilcon B) | OXYLENS TINTED (hioxifilcon B) | PREDICATE DEVICE(S) |
|---|---|---|---|
| Production Method | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Material | Hydrophilic Polymer | Hydrophilic Polymer | Hydrophilic Polymer |
| Water Content | 48% | 48% | 38%, 48% |
| Polymer Content | 52% | 52% | 62%, 52% |
| Polymer | hioxifilcon B | hioxifilcon B | Polymacon, hioxifilcon B |
| DK Value (Oxygen Permeability) | 15 | 15 | 9, 15 |
| Refractive Index (hydrated) | 1.404 | 1.404 | 1.430, 1.404 |
| Specific Gravity (hydrated) | 1.136 | 1.136 | 1.18, 1.136 |
| Light Transmission | greater than 70% T (N/A for non-sighted eyes) | greater than 70% T | greater than 70% T |
| Color Additives | Vat Green 1, Vat Brown 1, Vat Blue 6 | Vat Green 1, Vat Brown 1, Vat Blue 6, Vat Yellow 3, Vat Orange 1 | Vat Blue 6 (for predicate); Not Applicable for Clear Contact Lens |
| Lens Function | Enhance/alter eye color, ocular masking, refractive error correction (ametropia, astigmatism), occlusive therapy. | Refractive medium, enhancing/altering eye color. | Enhance/alter eye color, ocular masking, refractive error correction (ametropia, astigmatism), occlusive therapy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This 510(k) submission does not include a clinical study with a test set of data. The submission demonstrates substantial equivalence based on the device's design, materials, and intended use being similar to already approved predicate devices. It references "pre-clinical toxicology and manufacturing/chemistry data" but does not detail any specific human clinical testing for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. No ground truth establishment by experts for a test set is described, as no specific clinical study data is presented for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As no clinical study or test set is described, there is no adjudication method.
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-assisted device, and no MRMC study or comparative effectiveness study is presented in the 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a contact lens and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No explicit ground truth based on expert consensus, pathology, or outcomes data is mentioned as there is no specific clinical study for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness profiles of the predicate devices and the similarity of the new device to them.
8. The sample size for the training set
Not Applicable. This involves a physical medical device (contact lens), not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
Not Applicable. See response to item 8.
§ 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.