(70 days)
HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The HYDROGENIC® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):
- +10.00 D to -10.00 D Asphere
- with center thickness from 0.025mm to 0.40mm
- . with base curves of 8.00mm to 9.20mm
- . with diameter of 12.00mm to 18.00mm
The lens material for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same as the Biomedics® 60 UV (ocufileon F) lens in spherical design as described in submission K992264 cleared on November 24, 1999.
The aspheric lens design for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same design construct as the BIOMEDICS® UV ASPHERE (ocufilcon D) as cleared in K020193 on February 28, 2002.
The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This front optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range.
This document is a 510(k) Premarket Notification for a contact lens, indicating that clinical studies were not deemed necessary to establish safety and efficacy because the device was determined to be substantially equivalent to previously cleared predicate devices. Therefore, the information provided does not contain details about specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment in the context of a new clinical performance study.
Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:
1. A table of acceptance criteria and the reported device performance
The document compares the subject device, HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens, to predicate devices, primarily HYDROGENICS® 60 UV Sphere and BIOMEDICS® 55 UV Asphere, to demonstrate substantial equivalence. The "acceptance criteria" are implied by the characteristics of the predicate devices which the new device must match or be equivalent to.
| Characteristic | Predicate Device (HYDROGENICS® 60 UV Sphere/BIOMEDICS® 55 UV Asphere) | Subject Device (HYDROGENICS® 2.0 60 UV ASPHERE) | Acceptance/Equivalence Indication |
|---|---|---|---|
| Production Method | Cast molded process | Cast molded process | Equivalent |
| Intended Use | Daily wear, Correction of ametropia | Daily wear, Correction of ametropia | Equivalent |
| Material (ocufilcon F) | 60% | 60% | Equivalent |
| Material Type | Group IV | Group IV | Equivalent |
| Color additive | Vat Blue 6 Dye | Vat Blue 6 Dye | Equivalent |
| UV additive | Yes | Yes | Equivalent |
| Dk permeability (x $10^{-11}$) | 25.3 | 25.3 | Equivalent |
| Light transmittance (Tv, % @ 20°C) | 97.7% (between 380-780 nm) | >95% (between 400-800 nm) | Comparable (with slight range difference) |
| Base Curve, mm (-2.00 D) | Labeled: 8.6, Measured: 8.4 (for BIOMEDICS® 55 UV Asphere) | Labeled: 8.5, Measured: 8.5 | Comparable |
| Diameter, mm (-2.00 D) | Labeled: 14.2, Measured: 14.1 (for BIOMEDICS® 55 UV Asphere) | Labeled: 14.1, Measured: 14.08 | Comparable |
| Power, D (-2.00 D) | Labeled: -2.00, Measured: 2.13 (for BIOMEDICS® 55 UV Asphere) | Labeled: -2.00, Measured: -1.97 | Comparable |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Clinical studies were not performed for this device submission as stated in Section 7: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the HYDROGENICS®2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses". Therefore, there is no test set sample size or data provenance from a new clinical study. The submission relies on equivalence to predicate devices, whose data provenance is not specified in this document.
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, as no new clinical studies were conducted that required expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical studies were conducted requiring adjudication.
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 device is a contact lens, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable for a new clinical study. The "ground truth" for the device's characteristics and safety/efficacy is established by the successful marketing and clearance of its predicate devices and the physical/chemical properties demonstrating equivalence.
8. The sample size for the training set
Not applicable, as no new clinical trials were conducted. For the manufacturing information and finished lens parameters comparison, sample sizes for quality control testing are implied but not specified in this summary.
9. How the ground truth for the training set was established
Not applicable, as no new clinical trials were conducted that would involve a "training set" in the context of device performance evaluation. The "ground truth" for the predicate devices' safety and efficacy would have been established through their respective clearance processes, likely including clinical trials and performance testing, but details are not provided in this document.
§ 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.