(118 days)
CIBA Vision® (nelfilcon A) Spherical and Toric One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.
CIBA Vision® (nelfilcon A) Progressives One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The nelfilcon A lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyaninks (UD).
Nelfilcon A lens designs currently include spherical, toric, and multifocal in the following parameter ranges:
Power Range: -20.00D to +20.00D
Center Thickness: 0.010 mm for -3.00D spherical (varies with power)
Lenses have the following properties:
Refractive index: 1.38
Light transmittance: approximately 96 %T
Water content : 69% by weight
Oxygen permeability . 26 barrer measured at 35°C (single point Dk-Polarographic method)
Lenses are supplied sterile in sealed blister-packs containing buffered saline.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Nelfilcon A Soft Contact Lenses for Daily Wear
1. Table of Acceptance Criteria and Reported Device Performance
The document describes "Substantial Equivalence" as the primary acceptance criterion, meaning the device must perform comparably to a predicate device. Specific quantitative acceptance criteria are not explicitly detailed in threshold values (e.g., "must achieve X% vision improvement"). Instead, the performance is described relative to the predicate device and established standards for contact lenses.
| Acceptance Criteria (Demonstrates Substantial Equivalence To Predicate) | Reported Device Performance |
|---|---|
| Non-clinical: | |
| Lens physical and material properties are substantially equivalent. | Demonstrated. |
| Lens material and extracts are substantially equivalent, non-toxic, and non-irritating. | Demonstrated. |
| Clinical: | |
| Similar overall performance in clinically relevant areas: | Demonstrated. |
| - Vision | Satisfactory. |
| - Health | Satisfactory. |
| - Comfort | Satisfactory. |
| - Fit | Satisfactory. |
| Overall Equivalence: | |
| Comparable to predicate device and other Group II soft hydrophilic contact lenses in: | Demonstrated. |
| - Water content (69% water) | (Matches predicate) |
| - Ionic characteristics (FDA Group II: high water, nonionic) | (Matches predicate) |
| - Clinical performance | Demonstrated. |
| - Indications for use | Demonstrated. |
| Any differences do not adversely affect safety and effectiveness. | Demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "a clinical study" and "an investigation" but does not provide the number of subjects or eyes included in the clinical test set.
- Data Provenance: Not explicitly stated regarding country of origin. The study was a "daily disposable wear investigation." The document implies that the study was prospective, as it "investigated" the lens and was performed to "demonstrate" substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For contact lens studies demonstrating substantial equivalence, "ground truth" often refers to clinical assessments by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed here.
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, as typically understood in AI/medical imaging, was not performed. The study compared the device's clinical performance to an "FDA cleared and commercially available contact lens" (the control/predicate), but this is a direct clinical comparison, not a study of human readers improving with AI assistance. The device itself is a contact lens, not an AI system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A (Not Applicable). The device is a physical medical device (contact lens), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The "standalone" performance would be the lens's inherent physical and optical properties, which were part of the non-clinical testing.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would be established physical and material property measurements, and standard biocompatibility assays. For clinical testing, the "ground truth" was established through clinical assessments by medical professionals comparing the performance of the CIBA Vision® (nelfilcon A) lens to a control lens in terms of vision, health, comfort, and fit. This type of ground truth is based on expert clinical observation and evaluation, not pathology or outcomes data in the traditional sense for diagnostic devices.
8. The Sample Size for the Training Set
N/A (Not Applicable). The device is a physical contact lens, not an AI system or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A (Not Applicable), as there is no training set for a physical contact lens 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.