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Alcon (serafilcon 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 with up to approximately 1.50 diopters of astignatism that does not interfere with visual acuity.

Alcon for Astigmatism (serafileon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism.

Alcon Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

Alcon Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.

The lenses are to be prescribed for daily wear with removal for disposal, or cleaning and heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded with a new pair each week, or more often, if recommended by the eye care professional.

The subject device is made from a silicone containing hydrogel lens material that is approximately 55% water and 45% serafilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edge-to-edge color to make it easier to see when handling. In addition, lenses contain two benzotriazole monomers to block UVA and UVB radiation, and additionally, reduce transmittance in the range of 380 nm to 450 nm.

Serafilcon A represents a Group 5B silicone hydrogel contact lens material ('enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications.

Serafilcon A lens designs include spherical, toric, multifocal toric lenses in the following parameter ranges:

• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00 D to +20.00 D
• Center Thickness: varies with design and power (Example: 0.08 mm for -3.00 D spherical)
• Cylinder Power (toric) Range: -0.25 D to -10.00 D
• Cylinder Axis (toric) Range: 001 to 180°
• ADD Power (multifocal) Range: LO, MED, HI

Lenses have the following properties:

• Refractive index: 1.40 (hydrated)
• Water content : 55% by weight in normal saline
• Oxygen permeability: 119 x 10 -11 [(cm2 /sec)(ml O2 /mlommHg)] measured at 35 °C (normalized Dk-Polarographic method)
• Light transmittance: ≥85%
• UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 to 380 nm for the entire power range.

Serafilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents.

The provided text describes the Alcon™ contact lenses and their substantial equivalence to a predicate device, CooperVision Biofinity (comfilcon A) soft contact lens. However, the text details the testing performed to demonstrate safety and performance for the contact lenses themselves, not the acceptance criteria and performance of an "AI/algorithm device" as implied by the structure of the request.

Therefore, I cannot extract the information required for the requested table and study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, and training ground truth establishment) because the document does not concern an AI/algorithm device.

The document discusses the following:

• Device Name: Alcon™, Alcon™ for Astigmatism, Alcon™ Multifocal, Alcon™ Multifocal Toric (serafilcon A) soft contact lenses
• Predicate Device: CooperVision Biofinity (comfilcon A) soft contact lens
• Performance Data: A series of nonclinical tests (biocompatibility, physical-chemical, solution compatibility, sterilization, and stability) and a clinical study were performed to demonstrate substantial equivalence.
• Clinical Study Details:
  • Design: Prospective, randomized, stratified, controlled, double-masked, parallel group study.
  • Study Sites: Eight (8) sites in the US.
  • Subjects Enrolled: 120 subjects (240 eyes), with 119 randomized and exposed, and 110 completing the study.
  • Ratio: 2:1 ratio of test (serafilcon A, 78 subjects) to control (comfilcon A, 41 subjects).
  • Wear Modality: Daily wear for approximately 3 months.
  • Replacement Schedule: Test lenses replaced weekly, control lenses monthly.
  • Primary Effectiveness Endpoint: Study lens visual acuity at distance.
  • Other Assessments: Refraction, keratometry, lens fit, surface characteristics, subjective ratings of vision, comfort, and handling.
  • Conclusion: The study showed similar clinical performance between test and control lenses in vision, comfort, fit, handling, and health, demonstrating substantial equivalence.

Since the request is specifically for an algorithm/AI device, and the provided text is about contact lenses, I am unable to fulfill the request as stated.

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