(102 days)
CIBA Vision® (sifilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.50 diopters or less of astigmatism.
CIBA Vision® Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 10.00 diopters (D) or less of astigmatism.
CIBA Vision® Multifocal (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism.
CIBA Vision® Multifocal Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and have 4.00 diopters (D) or less of astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eve care professional.
The lens material is 32% water and 68% sifilcon A a fluoro-silicone containing hydrogel which is surface treated.
Sifilcon B lens designs include spherical, toric, multifocal and multifocal toric in the following parameter ranges:
Diameter Range: 12.0 to 15.0 mm
Base Curve Range: 7.0 to 9.2 mm
Power Range: -20.00D to +20.00D
Center Thickness: 0.070 mm for -3.00D spherical (varies with power)
Lenses contain the color additive Phthalocyanine Green (PCN Green), a light green handling tint, which makes them easier to see when handling.
Lenses have the following properties:
Refractive index: 1.43 (hydrated)
Light transmittance: approximately 92 %
Water content : 32% by weight in normal saline
Oxygen permeability: 82 x 10 -11 [(cm2 /sec)(ml O2 /ml=mmHg)] measured at 35°C (intrinsic Dk-Polarographic method)
Lenses are supplied sterile in sealed blister-packs containing isotonic phosphate buffered saline solution.
The provided document describes the safety and substantial equivalence of CIBA Vision's Sifilcon A Soft Contact Lenses for Daily Wear (K062262) to a previously cleared predicate device (Lotrafilcon B).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative table for clinical performance. Instead, it describes demonstrating "similar overall performance" to the predicate in key areas. For non-clinical, it uses terms like "consistent with or better than" and "substantially equivalent."
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance (Sifilcon A) |
|---|---|---|
| Non-Clinical | ||
| Lens Physical/Material Properties | Consistent with or better than industry marketed lenses; substantially equivalent to predicate lens. | Consistent with or better than industry marketed lenses; substantially equivalent to the predicate lens. |
| Compatibility with Lens Care Products | Compatible with commonly available lens care products. | The lens material is compatible with commonly available lens care products. |
| Biocompatibility | Non-toxic and biocompatible; substantially equivalent to predicate device and non-toxic/non-irritating. | Substantially equivalent to the predicate device and are non-toxic and non-irritating. |
| Clinical | ||
| Overall Performance | Similar performance to predicate in vision, health, comfort, and fit. | Demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit as compared to the control lens. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions a "daily wear clinical study" but does not specify the sample size for this clinical evaluation.
- Data Provenance: The clinical study was conducted in accordance with current Good Clinical Practices (GCP) and published regulations (21 CFR Parts 50, 56, 312, and 812). It compares the sifilcon A lens to an "FDA approved and commercially available contact lens." The country of origin for the data is not explicitly stated, but given FDA submission, it's highly likely to be within the USA or a region adhering to similar regulatory standards for clinical trials. The study is a prospective clinical investigation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts & Qualifications: The document does not specify the number of experts or their qualifications used to establish ground truth in the clinical study. It implies that "eye care professionals" would recommend the lenses for daily wear, but this is about prescription, not ground truth establishment for the study itself. Clinical studies for contact lenses typically involve ophthalmologists or optometrists assessing patient outcomes, but specific details are absent.
4. Adjudication Method for the Test Set:
- Adjudication Method: The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
- MRMC Study: This is not applicable as the device is a medical product (contact lens), not an AI or imaging diagnostic tool that would typically involve multiple readers interpreting cases. The clinical study was a comparison of device performance between two contact lens types.
- Effect Size: No effect size in terms of human reader improvement with/without AI assistance is mentioned or relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: This is not applicable as the device is a contact lens, not a computational algorithm. The evaluation focuses on the performance of the physical lens as used by human wearers.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the clinical testing, the "ground truth" would be established by direct clinical observations and measurements of patient outcomes (e.g., vision, lens fit, comfort, ocular health assessments) performed by qualified medical professionals (e.g., ophthalmologists, optometrists). For non-clinical testing, it would be based on validated laboratory measurements and biocompatibility assessments.
8. The Sample Size for the Training Set:
- Training Set Sample Size: The concept of a "training set" is not applicable to this type of device (contact lens). There is no machine learning model being trained. The "training" for the device would be the manufacturing process and quality control.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: As there is no training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and manufacturing would be established through material specifications, engineering design principles, and quality control standards.
§ 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.