(81 days)
SPHERICAL AND ASPHERICAL:
BIOFINITY (comfilcon 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:
BIOFINITY (comfilcon 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:
BIOFINITY (comfilcon 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 BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The BIOFINITY (comfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high oxygen permeability (Dk). The lens material, comfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. The lenses are made by cast molding. 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 0.50 mm
• Base Curve: 8.0 mm to 9.5 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 +3.00D
• Refractive Index (hydrated): 1.40
• Water Content: 48% by weight in normal saline
• Oxygen permeability: 128 x 10-11 [(cm2/sec)(ml O2)/ml*mmHg], 34°C, Coulometric method
The lens is supplied sterile in blister packs containing a buffered saline solution. Blister labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterifization process.
The "BIOFINITY (comfilcon A) Soft Contact Lens" study aimed to demonstrate substantial equivalence to predicate devices, namely CIBA Vision SEE3™ (lotrafilcon A) and CIBA Vision O2OPTIX™ (lotrafilcon B) Soft Contact Lenses. The study focused on performance and safety for daily wear. Due to the nature of the device (contact lenses), acceptance criteria and performance are primarily assessed through physical, optical, chemical, and clinical measures, rather than typical AI model metrics like sensitivity/specificity.
Here's an analysis based on the provided text, adapted to the requested format where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices across various physical, chemical, optical, and clinical parameters. The study aimed to show no significant differences in performance and safety compared to the predicate device, CIBA Vision Focus Night & Day.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices and "no significant difference") | Reported Device Performance (BIOFINITY) |
|---|---|---|
| Visual Acuity Performance | No significant difference compared to predicate device (CIBA Vision Focus Night & Day). | Showed no significant difference compared to predicate device. |
| Clinical Adverse Events | No significant difference in patient complaints or slit lamp observations compared to predicate device. No serious or significant adverse events attributable to the device. | Showed no significant difference of clinical adverse events compared to predicate device. No serious or significant adverse events attributable to the device. |
| Biocompatibility | Pass ISO 10993 standards for cytotoxicity, maximization sensitization, ocular irritation, and systemic toxicity. | All results passed with no evidence of adverse clinical effects. |
| Material Properties | Substantially equivalent physical, optical, and chemical properties to predicate devices (SEE3™ and O2OPTIX™). | Presented in a table of characteristics, indicating substantial equivalence in most properties while noting differences in others (e.g., water content, Dk, surface treatment, modulus, tensile strength, elongation to break). The submission argues these differences do not preclude substantial equivalence for the intended use given other studies. |
| Leachable Substances | Low or below measurable levels. | Determined to be low or below measurable levels. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of participants in the human clinical studies. It mentions "a study of daily wear."
- Data Provenance: The study was a "Human Clinical Studies" which implies prospective data collection, specifically a clinical trial. The country of origin for the data is not specified, but the manufacturer is based in the UK and Applicant in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not directly applicable in the context of ground truth for an AI algorithm. For a contact lens clinical study:
- Experts: The clinical study would have involved ophthalmologists or optometrists who conducted the visual acuity assessments and slit lamp observations.
- Qualifications: While not explicitly stated, these would be medical professionals with expertise in ophthalmology and contact lens fitting/assessment.
4. Adjudication Method for the Test Set
This term is not typically used for clinical studies of medical devices like contact lenses in the same way it would be for an AI algorithm's ground truth. Clinical studies usually involve:
- Clinical Assessments: Visual acuity, slit lamp examinations, and patient complaints would have been recorded by the clinical investigators.
- Data Analysis: Statistical analysis would then be performed on the collected data to compare the new device to the predicate device.
- Expert Review: The overall results and findings would be reviewed by regulatory affairs specialists and potentially medical experts to determine safety and efficacy.
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 study is for a physical medical device (contact lens), not an AI algorithm assisting human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This study concerns a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
For this type of device, what constitutes "ground truth" revolves around established clinical endpoints and validated measurement techniques:
- Clinical Outcomes:
- Visual acuity: Measured objectively using standard eye charts.
- Ocular health: Assessed via slit lamp examination by clinicians for signs of adverse events (e.g., corneal edema, infiltrates, hyperemia).
- Patient symptoms/complaints: Reported directly by study participants.
- Biocompatibility Standards: Compliance with ISO 10993 standards (cytotoxicity, sensitization, irritation, systemic toxicity) serves as a "ground truth" for material safety.
- Physicochemical Measurements: Laboratory measurements of material properties (e.g., Dk, water content, modulus, refractive index) compared against established ranges or predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This study did not involve an AI algorithm with a distinct training set. The "training" for a physical device involves material formulation, manufacturing process development, and quality control, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, this question is not relevant. The "ground truth" for the development of the contact lens itself would stem from extensive research and development in polymer science, optics, and biocompatibility, guided by regulatory requirements and clinical needs for contact lens performance.
§ 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.