(167 days)
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic in powers from -20.00, possess astigmatism to -5.75 diopters, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only),
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 that are myopic or hyperopic and are presbyonic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic and hyperopic in powers from -20.00 to +20.00 diopters and astigmatism corrections to -5.75 diopters. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
The Proclear Toric XR, Multifocal XR and Multifocal Toric (omafilcon A) Contact Lenses are made from a material containing 59% water and 41% omafilcon A, a polymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge for visibility purposes with Vat Blue 6.
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lens is a back surface toric.
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear Multifocal XR is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic.
The provided document is a 510(k) summary for CooperVision's Proclear Toric XR, Multifocal, and Multifocal XR Daily Wear Soft Contact Lenses. It details non-clinical testing performed to assess the safety and effectiveness of the contact lenses.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity Test ISO 10993 - 5: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity | All 3 monolayers exposed to the test article show no grade greater than grade 2 (reactivity mild) | Pass |
| ISO Ocular Irritation ISO 10993 - 10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed Hypersensitivity | Test extract shows no significant irritation over the reagent control during the observation period. | Pass |
| Systemic Toxicity Study ISO 10993 - 11: Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity. | During the observation period, none of the animals treated with the individual test extract exhibit a significantly greater reaction than the control animals. | Pass |
| ISO Contact Lens 22 Day Ocular Irritation Study ISO 9394 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products The determination of Biocompatibility by Ocular Study with Rabbit Eyes. | Scores from macroscopic and microscopic ocular examinations equivalent between test and control eyes. | Pass |
| Total Extractables, Water content, Dk, Light Transmittance, refractive index tested per ISO 18369-4:2006 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials: section 4.2 | Equivalent to predicate lens | Pass |
2. Sample size used for the test set and the data provenance
The document describes non-clinical laboratory tests using in-vitro and in-vivo methods. Specific sample sizes for each test are not explicitly stated. The in-vivo tests (Ocular Irritation Study, Systemic Toxicity Study) were conducted on animals (rabbits for ocular studies; the specific animal for systemic toxicity is implied but not named with a precise number).
The data provenance is from non-clinical laboratory studies conducted by "Contract laboratories under Good Manufacturing Practice regulations" and "CooperVision" itself for chemistry, shelf-life, and leachability studies. The country of origin for the data is not specified beyond "Contract laboratories" and CooperVision's internal studies. These are prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The tests described are laboratory-based, non-clinical evaluations (cytotoxicity, irritation, systemic toxicity, physicochemical properties). "Ground truth" in the context of expert consensus or clinical evaluation is not relevant here. The evaluation criteria are based on scientific standards (ISO norms) and controlled experimental results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies where experts review cases for a diagnosis or outcome. The tests conducted were laboratory tests with objective pass/fail criteria based on quantitative measurements and observations, not subjective expert adjudication of patient cases.
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
This section is not applicable. The device is a physical medical device (contact lens), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. As stated above, the device is a physical contact lens, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by:
- Scientific Standards: Adherence to established ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 9394, ISO 18369-4).
- Controlled Experimental Results: Objective measurements and observations from in-vitro assays and animal studies, interpreted against predefined acceptance criteria. For example, for cytotoxicity, the "ground truth" is no more than grade 2 reactivity; for ocular irritation, no significant irritation over control.
- Predicate Device Equivalence: For physicochemical properties (Water content, Dk, Light Transmittance, refractive index), the "ground truth" is equivalence to the predicate lens.
8. The sample size for the training set
This section is not applicable. The document describes non-clinical testing for contact lenses, which does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 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.