Search Results

Sphere/Asphere:
Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel 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 -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric:
Innova Vision Toric (inifilcon A) Silicone Hydrogel 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 -2.25 diopters.

Multifocal:
Innova Vision Multifocal (inifilcon A) Silicone Hydrogel 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 in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric:
Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with nondiseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.

Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN).

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens contains C.I. Reactive Blue 247 (21 CFR Part 73.3100 ) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel (Hvdrophilic) Daily Wear Soft Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315mm - 380mm). The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.

This document is an FDA 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets those criteria (such as test sets, expert ground truth, MRMC studies, standalone performance, etc.) is not present in this document.

The document focuses on demonstrating substantial equivalence of a new contact lens (Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens) to legally marketed predicate devices, primarily K232139, K222954, and K210436.

Instead of AI/ML performance metrics, the acceptance criteria for this medical device are related to its physical properties, biocompatibility, and intended use, demonstrating that it is as safe and effective as existing contact lenses.

Here's an attempt to extract relevant information from the provided text, reinterpreting "acceptance criteria" and "study" in the context of a contact lens submission:

Acceptance Criteria and Device Performance (Reinterpreted for a Contact Lens)

• Acceptance Criteria: To demonstrate substantial equivalence, the new device must meet specific physical, chemical, and biological performance standards comparable to predicate devices. This includes demonstrating:

  • Absence of cytotoxicity, systemic toxicity, and ocular irritation.
  • Stability, sterility, and package integrity over the labeled shelf life.
  • Compatibility with common cleaning and disinfection solutions.
  • Consistent material properties (refractive index, water content, oxygen permeability, UV transmission, tensile strength, modulus, elongation to break, specific gravity) within acceptable tolerances.
  • Similar indications for use and general function as the predicate devices.

• Reported Device Performance: The document states that the non-clinical performance testing (toxicology, shelf life, solution compatibility, preservative uptake and release, and bench tests) supports the claim that the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the currently marketed predicate devices. Specific numerical results demonstrating compliance with each criterion are not provided in this summary, but the conclusion confirms they were met.

Table of Acceptance Criteria and Reported Device Performance (Reinterpreted)

Information Not Applicable or Not Found (as per AI/ML context):

1. Sample size used for the test set and data provenance: Not applicable in the AI/ML sense. The "test set" here refers to the actual manufactured devices undergoing physical and biological testing. The number of batches or lenses tested for each criterion is not specified in this summary. The "data provenance" would refer to internal lab testing.
2. Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for a contact lens is established through objective physical, chemical, and biological measurements, not expert consensus on images.
3. Adjudication method for the test set: Not applicable. Compliance is measured objectively.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance.
5. Standalone (algorithm-only) performance: Not applicable. This is a physical medical device.
6. Type of ground truth used: For this device, the "ground truth" is derived from established standard test methods (e.g., ISO 10993 for biocompatibility, methods for Dk, water content, etc.) that yield objective measurements of the device's properties.
7. Sample size for the training set: Not applicable. There is no AI model being trained.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document outlines the non-clinical and clinical (by reference to predicate) evidence used to demonstrate the substantial equivalence of a new contact lens. It does not contain the specific AI/ML-related details requested in the prompt because the device is a physical product, not an AI algorithm.

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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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