(108 days)
SUS (stenfilcon A) ASPHERE Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00D to +20.00D diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
SUS (stenfilcon 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.
SUS (stenfilcon A) MULTIFOCAL Soft Contact 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.
SUS (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.
The SUS (stenfilcon A) Contact Lens Visibility Tinted with UV Blocker is available as an aspherical lens, toric lens, multifocal lens, and multifocal toric lens. The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The SUS (stenfilcon A) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV Blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The SUS (stenfilcon A) lens is supplied sterile, packaged in a buffered saline solution. The composition of the lens is 46% stenfilcon A and 54% water by weight when hydrated and stored in buffered saline solution.
The acceptance criteria for the CooperVision SUS (stenfilcon A) Soft Contact Lens and the study proving it meets these criteria are detailed below:
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated by comparing its material and physical properties to two predicate devices (CooperVision AVAIRA and CooperVision CLEARSIGHT 1 DAY), and through a clinical study for safety and efficacy.
Material Comparison (vs. CooperVision AVAIRA (enfilcon A))
| Material Comparison | Predicate Device (CooperVision AVAIRA (enfilcon A)) | Subject Device (CooperVision SUS (stenfilcon A)) | Performance |
|---|---|---|---|
| Material USAN Name | Enfilcon A | Stenfilcon A | Different materials, but both silicone hydrogel, deemed acceptable. |
| FDA Category | Silicone Hydrogel | Silicone Hydrogel | Same classification. |
| Manufacturing Method | Molded | Molded | Same. |
| Sterilization | Moist Heat | Moist Heat | Same. |
| Packaging | Blister | Blister | Same. |
| Visibility Tint | Phthalocyanine Blue | Reactive Blue #246 | Different tint compounds, but both for visibility. |
Parameter Comparison (vs. CooperVision AVAIRA (enfilcon A))
| Parameter Comparison | Predicate Device (Avaira (enfilcon A)) - Measured | Predicate Device (Avaira (enfilcon A)) - Labeled | Subject Device (SUS (stenfilcon A)) - Measured | Subject Device (SUS (stenfilcon A)) - Labeled | Performance |
|---|---|---|---|---|---|
| Water Content, % | 45% | 46% | 54.3% | 54% | Different, but within expected range for contact lenses. |
| Refractive Index @ 20°C | 1.402 | 1.40 | 1.4011 | 1.40 | Similar. |
| Oxygen Permeability (Dk) | 99.6 | 100 | 79.2 | 80 | Permeability is lower but still within general silicone hydrogel range. |
| Base Curve, mm | 8.45 | 8.5 | 8.33 | 8.4 | Similar. |
| Diameter, mm | 14.26 | 14.2 | 14.12 | 14.2 | Similar. |
Material Comparison (vs. CooperVision CLEARSIGHT 1 DAY (ocufilcon B))
| Material Comparison | Predicate Device (CooperVision CLEARSIGHT 1 DAY (ocufilcon B)) | Subject Device (CooperVision SUS (stenfilcon A)) | Performance |
|---|---|---|---|
| Material USAN Name | Ocufilcon B | Stenfilcon A | Different materials. |
| FDA Category | Group IV | Silicone Hydrogel | Different categories, subject device is silicone hydrogel. |
| Manufacturing Method | Molded | Molded | Same. |
| Sterilization | Moist Heat | Moist Heat | Same. |
| Packaging | Blister | Blister | Same. |
| Visibility Tint | Vat Blue 6 | Reactive Blue #246 | Different tint compounds. |
Parameter Comparison (vs. CooperVision CLEARSIGHT 1 DAY (ocufilcon B))
| Parameter Comparison | Predicate Device (CLEARSIGHT 1 DAY (ocufilcon B)) - Measured | Predicate Device (CLEARSIGHT 1 DAY (ocufilcon B)) - Labeled | Subject Device (SUS (stenfilcon A)) - Measured | Subject Device (SUS (stenfilcon A)) - Labeled | Performance |
|---|---|---|---|---|---|
| Water Content, % | 51.04 | 52% | 54.3% | 54% | Similar or slightly higher. |
| Refractive Index @ 20°C | 1.415 | 1.41 | 1.4011 | 1.40 | Similar. |
| Oxygen Permeability (Dk) | 16.17 | 16.8 | 79.2 | 80 | Significantly higher (a benefit for silicone hydrogel). |
| Base Curve, mm | 8.85 | 8.7 | 8.33 | 8.4 | Similar. |
| Diameter, mm | 14.12 | 14.2 | 14.12 | 14.2 | Same. |
Acceptance Criteria for Clinical Study and Reported Performance:
The primary acceptance criteria for the clinical study were the evaluation of biomicroscopy and adverse event rates, and visual acuity comparisons, with secondary measures including wearing times and subjective comfort. The reported performance was:
- "The Test contact lens was found to be substantially equivalent to the Control contact lens for safety and efficacy."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): 90 male and female subjects.
- 60 subjects were dispensed the Test lenses (SUS (stenfilcon A)).
- 30 subjects were dispensed the Control lenses (unspecified control contact lens, likely one of the predicate devices or a similar established lens).
- Data Provenance: Not explicitly stated regarding country of origin, but the study was conducted by CooperVision, Inc., a US-based company, and submitted to the US FDA. The study was prospective in nature through a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The clinical study details do not specify the number or qualifications of experts involved in establishing ground truth (e.g., ophthalmologists or optometrists assessing biomicroscopy findings).
4. Adjudication Method for the Test Set
The adjudication method for the clinical study is not explicitly detailed in the provided text. It mentions "The primary outcome measures were biomicroscopy and adverse event rates along with lens visual acuity comparisons" without specifying how disagreements or interpretations among clinical evaluators were resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The clinical study described is for evaluating the safety and efficacy of the contact lens itself, not a comparison of human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a medical device (contact lens), not an AI algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was established based on biocompatibility and toxicology standards (GLP regulation - 21 CFR Part 56) and established scientific protocols for physical and material property measurements.
For the clinical study, the "ground truth" for efficacy and safety was based on:
- Clinical observations from biomicroscopy.
- Adverse event reporting.
- Visual acuity comparisons.
- Subjective assessments of comfort and wearing times.
This could be considered a form of expert clinical assessment/observation and patient-reported outcomes.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (contact lens) and not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.