(192 days)
SPHERICAL AND ASPHERICAL:
AQUAIR (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
TORIC:
AQUAIR (enfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
MULTIFOCAL:
AQUAIR (enfilcon A) MULTIFOCAL lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The lens may also be prescribed for single-use disposable daily wear.
DAILY DISPOSABLE:
The AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for single-use disposable wear.
FREQUENT REPLACEMENT:
The AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
The AQUAIR (enfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, enfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The lens will be manufactured in spherical, aspherical, toric and multifocal configurations with the following features and properties:
• Chord Diameter 13.5 mm to 15.0 mm
• Center Thickness 0.05 mm to 0.60 mm
• Base Curve 8.2 mm to 9.2 mm
• Power Range -20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric) -0.25 to -10.00 D
• Add Power (Multifocal) +0.50 to +4.00 D
• Refractive Index (hydrated) 1.40
• Water Content 46% by weight in normal saline
• Oxygen permeability 100 x 10-11 [(cm²/sec)(ml O₂)/ml*mmHg]], 34°C, Polarographic method (corrected)
The lens is supplied sterile in blister packs containing a buffered saline solution. Labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating is established based on studies of product stability, package integrity, and sterility.
The CooperVision AQUAIR (enfilcon A) Soft Contact Lens's acceptance criteria and the study proving it meets them are described in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define numerical "acceptance criteria" but rather demonstrates substantial equivalence to predicate devices for various physical, optical, chemical, and clinical performance parameters. The table below summarizes these comparative characteristics, with the "Reported Device Performance" for AQUAIR indicating how it compares to the predicate devices.
| Characteristic | Predicate Device (BIOFINITY) Performance | Predicate Device (O2 OPTIX™) Performance | AQUAIR (enfilcon A) Reported Performance | Acceptance Criteria (Implicit: Substantial Equivalence to Predicates) |
|---|---|---|---|---|
| Material | comfilcon A (silicone hydrogel) | lotrafilcon B (silicone hydrogel) | enfilcon A (silicone hydrogel) | Similar material type (silicone hydrogel) |
| Category (Group) | Group I (low water, nonionic) | Group I (low water, nonionic) | Group I (low water, nonionic) | Same Group Classification |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded | Same manufacturing method |
| Indication | Daily Wear | Daily Wear | Daily Wear | Same intended wear schedule |
| Water Content (%) | 48 | 33 | 46 | Within acceptable range for soft contact lenses |
| Oxygen Permeability - Dk | $128 \times 10^{-11}$ | $110 \times 10^{-11}$ | $100 \times 10^{-11}$ | High oxygen permeability, comparable to silicone hydrogels |
| Refractive Index | 1.40 | 1.42 | 1.40 | Similar refractive index |
| Light Transmittance (%) | > 97 | > 96 | > 97 | High light transmittance, comparable to clear lenses |
| Chord Diameter Range (mm) | 13.5 to 15.0 | 13.0 to 15.0 | 13.5 to 15.0 | Within comparable ranges |
| Base Curve Range (mm) | 8.0 to 9.5 | 8.0 to 9.2 | 8.2 to 9.2 | Within comparable ranges |
| Center Thickness (mm) | 0.08 @ -3.00D | 0.08 @ -3.00D | 0.08 @ -3.00D | Similar center thickness |
| Powers | -20.00D to +20.00D | -1.00 to -6.00D | -20.00D to +20.00D | Broad power range, comparable to full-range lenses |
| Biocompatibility | (Implicitly passed) | (Implicitly passed) | Passed | No evidence of adverse clinical effects |
| Visual Acuity Performance | (Historical data) | (Historical data) | No significant difference from predicate | No significant difference |
| Clinical Adverse Events | (Historical data) | (Historical data) | No significant difference from predicate | No significant difference |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the "test set" in the context of device performance testing. Instead, it refers to "Human Clinical Studies" that compared the AQUAIR lens to historical data of the COOPERVISION BIOFINITY lens. This implies that the 'test set' for clinical performance was the group of participants in the clinical study of AQUAIR.
- Sample Size: Not explicitly stated for the clinical study.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "clinical study" and referenced "historical data" for the predicate device, suggesting a prospective study for AQUAIR's clinical evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The clinical study assessed "visual acuity performance" and "patient complaints or/and slit lamp observations" for safety, but no details are given about the number or qualifications of experts involved in establishing ground truth or evaluating these outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This device is a contact lens, and its evaluation focuses on its physical properties, biocompatibility, and direct clinical effects on patients, not on aiding human interpretation of medical images.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, a standalone algorithm-only performance study was not done. This device is a physical contact lens, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the clinical study, the ground truth was established by:
- Visual acuity performance: This would be assessed using standard ophthalmic measurements, comparing to the predicate.
- Patient complaints: Direct subjective feedback from patients.
- Slit lamp observations: Objective clinical observations by practitioners (presumably an optometrist or ophthalmologist) regarding ocular health and adverse events.
These assessments were compared against historical data for the predicate device.
For toxicology studies, the ground truth was based on:
- ISO 10993 standards: These provide established benchmarks and methods for assessing cytotoxicity, maximization sensitization, ocular irritation, and systemic toxicity. Animal GLP studies were conducted based on these standards.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a contact lens, not an AI model, so there is no "training set" in the AI sense. The "training" in manufacturing (e.g., initial production runs, quality control) is implicitly covered by standard manufacturing practices, but no specific "training set" data is discussed.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no "training set" in the context of AI development for this medical device.
§ 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.