(20 days)
Tetrafilcon A lenses are intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in not-aphakic persons with non-diseased eyes.
The Preference® standard, CooperHT™, CooperHT™, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lenses can be worn by persons who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity.
The PreferenceToric™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism up to 9.00 diopters and can obtain satisfactory visual acuity, in a spherical range of -20.00 to +12.00.
All tetrafilcon A Soft (hydrophilic Contact Lenses are hemispherical shells and are available as a spherical or astigmatic lens. When place on the cornea, the hydrated lens acts as a refracting medium to focus light rays on the retina.
The lens material is a hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone and methylmethacrylate joined in a three dimensional network of terpolymer chains by divinylbenzene cross links.
When produced with a handling tint, the dye C.I. Reactive Blue 163 is chemically bound to the polymer to impart a light blue tint on the lens. The handling tint increases the visibility of the lens when not worn on the eye.
This document describes a 510(k) submission for CooperVision's tetrafilcon A soft contact lenses. It focuses on demonstrating substantial equivalence to a predicate device, specifically regarding a change in the tinting process from post-hydration to in-monomer.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantified table format for each performance metric. Instead, it states that "Physical and chemical testing was performed on the lenses made by Aspect using an in-monomer tint as called for in the May 1994 Premarket Notification (510(k) Guidance Document for Daily Wear Contact Lenses." The reported performance is then compared to these established guidelines or the predicate device.
However, we can infer the tested parameters and the general conclusion of equivalence.
| Parameter Tested | Implicit Acceptance Criteria | Reported Device Performance (In-monomer tinted lenses) |
|---|---|---|
| Water Content | Equivalent to predicate device / within established guidelines for daily wear lenses | Tested and found to be equivalent to the predicate post-hydration tinted lenses. |
| Light Transmittance | Equivalent to predicate device / within established guidelines for daily wear lenses | Tested and found to be equivalent to the predicate post-hydration tinted lenses. |
| Refractive Index | Equivalent to predicate device / within established guidelines for daily wear lenses | Tested and found to be equivalent to the predicate post-hydration tinted lenses. |
| Mechanical Properties | Equivalent to predicate device / within established guidelines for daily wear lenses | Tested and found to be equivalent to the predicate post-hydration tinted lenses. |
| Toxicity (Cytotoxicity) | Acceptable levels (as per established standards) | Passed |
| Toxicity (Ocular Irritation Study) | Acceptable levels (as per established standards) | Passed |
| Toxicity (Acute Systemic Study) | Acceptable levels (as per established standards) | Passed |
| Design | Same as predicate device | The in-monomer tinted lenses have the same design as the predicate post-hydration tinted lenses. |
| Indication for Use | Same as predicate device | The in-monomer tinted lenses have the same indication for use as the predicate post-hydration tinted lenses. |
| Directions for Use | Same as predicate device | The in-monomer tinted lenses have the same directions for use as the predicate post-hydration tinted lenses. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (number of lenses or patients) used for each physical, chemical, and toxicity test. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. It only mentions that the testing was "performed on the lenses made by Aspect using an in-monomer tint."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this submission. The study described focuses on non-clinical, laboratory-based physical, chemical, and toxicity testing of contact lenses, not on interpreting images or patient conditions where expert consensus would be required for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this involves laboratory testing against established physical/chemical properties and toxicity standards, not clinical adjudication of patient data or images.
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 a 510(k) submission for a medical device (contact lenses), not an artificial intelligence (AI) or software product. Therefore, no MRMC study to compare human readers with and without AI assistance was performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the physical and chemical tests (water content, light transmittance, refractive index, mechanical properties) would be the established scientific and engineering standards for contact lens materials and manufacturing, often defined in ISO standards or recognized industry guidelines, or by direct comparison to data from the predicate device. For toxicity studies, the ground truth would be pre-defined safety thresholds and biological response criteria as outlined in relevant regulatory guidelines for medical device biocompatibility (e.g., ISO 10993 series).
8. The Sample Size for the Training Set:
Not applicable. This is not an AI or machine learning model that requires a training set. The "study" described is a series of non-clinical, laboratory-based tests.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device submission.
§ 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.