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The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lens may be disinfected using a chemical disinfection system.

Device Description

The UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 8.5 to 10,5 mm . 0.10 mm to 0.28 mm Center Thickness: . 7.0 to 8.5 mm Base Curve: . +12.00 D to-20.00 D Powers: . The physical/optical properties of the lens are: Specific Gravity 1.105 . 1.57 at 20°C Refractive Index: . 98.5% Light Transmittance: . Hydrophobic Surface Character: . 0.5% Water Content: . 19° (CLMA method) Wetting Angle: . Oxygen Permeability (Dk) :: 44 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg) . at 35°C [Fatt method used for determination of oxygen permeability] 2. UltraCon S (carbosifiocon A) Rigid Gas Permeable Contact Lens for Daily Wear The UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The diameter of the lens is larger than conventional rigid gas permeable lenses, and the UltraCon S lens extends beyond the cornea and onto the limbal region. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 12.0 mm to 14.0 mm Center Thickness: 0.10 mm to 0.28 mm Base Curve: 7.0 to 8.5 mm Powers: +12.00 D to-20.00 D Peripheral Curves: C, D, and E The physical/optical properties of the lens are: Specific Gravity 1.105 Refractive Index: 1.57 at 20°C Light Transmittance: 96.5% Surface Character: Hydrophobic Water Content: 0.5% Wetting Angle: 19° (CLMA method) Oxygen Permeability (Dk): 44 x 10-11 (cm²/sec) (ml O₂ /ml x mm Hg) at 35°C *[Fatt method used for determination of oxygen permeability]

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format as performance metrics against predefined thresholds. Instead, it demonstrates substantial equivalence to a predicate device, implying that meeting or exceeding the predicate's characteristics constitutes acceptance. The "Comparison to Predicate Device" table serves as the primary source for this.

Parameter	UltraCon and UltraCon S (Reported Performance)	LifeStyle GP (Predicate Device Performance)	Note
Material	carbosilfocon A	telefocon B	Different material, but same classification. Non-clinical tests confirmed safety.
Material Classification	Hydrophobic Lens Group 2	Hydrophobic Lens Group 2	Same classification.
Indication for Use	myopia, hyperopia, astigmatism	myopia, hyperopia, astigmatism	Identical indications.
Water Content	0.5%	less than 0.5%	Comparable.
Light Transmittance	96.5%	96%	Comparable, slightly better.
Dk (35° C)	44 x 10⁻¹¹	43.5 x 10⁻¹¹	Comparable, slightly better.
Powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters	Identical.
Color	blue visibility	blue, green, brown, and gray	Different color options, but for visibility tint, not clinical performance.
Specific Gravity	1.105	1.126	Comparable.
Refractive Index	1.57 at 20° C	1.480 at 20° C	Different, but considered acceptable within the context of substantial equivalence.
Wetting Angle	< 19°	< 30°	Better (lower wetting angle generally indicates better wettability).
Method of Manufacture	Gel Flow Molding	Lathe cut	Different manufacturing method, but non-clinical tests confirmed safety and performance.

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated as a number of subjects. The text mentions a "three month clinical evaluation" and that "Performance of the UltraCon S lens was substantially equivalent to performance of the predicate lens with respect to safety and efficacy." The typical sample size for such a study in the 1990s could range from dozens to a few hundred, but the exact number is not provided.
Data Provenance: Prospective (clinical evaluation performed at six investigational sites). The country of origin is implicitly the USA, as Specialty UltraVision, Inc. is based in Campbell, CA, and the FDA is the regulatory body.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not explicitly stated. The "six investigational sites" suggest multiple clinicians/ophthalmologists were involved in the evaluation, but it doesn't specify if a panel of experts established a ground truth for the test set. Instead, their observations and assessments during the clinical evaluation constituted the "performance" data.
Qualifications of Experts: Implied to be ophthalmic professionals (e.g., ophthalmologists, optometrists) at the investigational sites, who are qualified to assess contact lens safety and efficacy. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set:

Adjudication Method: Not explicitly stated. The phrase "clinical evaluation... assessed the safety and effectiveness of the lens" suggests that data was collected, analyzed, and evaluated by the study investigators and then reviewed by the sponsor, but no specific adjudication method (like 2+1 voting) is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The study compared the UltraCon S lens's clinical performance to that of a predicate lens, which is a comparative study, but it wasn't presented as an MRMC analysis focused on human reader improvement with AI assistance. This device is a contact lens, not an AI diagnostic tool.
Effect Size of Human Readers with vs. without AI: Not applicable, as this is a medical device (contact lens) and not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

Standalone Performance: Not applicable, as this device is a physical contact lens, not an algorithm.

7. Type of Ground Truth Used:

For the clinical evaluation, the "ground truth" was established by clinical observation and assessment of safety and effectiveness by qualified ophthalmic professionals at the investigational sites. This includes direct patient examination, reporting of adverse events, and evaluation of visual acuity and lens fit. It's essentially "expert clinical assessment/outcomes data."
For the non-clinical testing, ground truth was based on standardized in vitro and in vivo toxicology, biocompatibility, and physicochemical tests.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This is a medical device (contact lens), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable, as there is no AI algorithm being trained.

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