Search Results

The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.

The M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical (not heat), or hydrogen peroxide disinfecting systems.

S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the "Optical Connection Inc." contact lenses.

It's important to note that this 510(k) submission is for contact lenses, a medical device in a different category than typical AI/ML-driven diagnostics. Therefore, many of the requested fields, particularly those related to "AI performance," "expert ground truth," "MRMC studies," "training set," and "adjudication methods" are not applicable or described in the context of this type of device. Medical devices like contact lenses primarily rely on physicochemical properties, biocompatibility, and clinical performance (in terms of vision correction and safety) which are established through different types of testing.

Acceptance Criteria and Device Performance for Optical Connection Inc. Contact Lenses (K040900)

1. Table of Acceptance Criteria and Reported Device Performance

For contact lenses, "acceptance criteria" and "performance" are typically related to the physical and chemical properties of the material and the lens design, as well as the safety of the materials. The summary does not provide specific numerical "acceptance criteria" against which a single "reported device performance" value is compared in a pass/fail manner for each characteristic. Instead, it demonstrates substantial equivalence to predicate devices by comparing their properties.

However, based on the comparative table, we can infer the target values (which act as de facto acceptance criteria by being "comparable to predicate devices") and the properties of the new device.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the context of physicochemical testing. These tests are typically performed on representative batches of the manufactured product to ensure consistency. For biocompatibility, testing is often done on a smaller, standardized set of samples.
• Data Provenance: Not explicitly stated, but these are typically laboratory tests performed by the manufacturer or contracted labs, often adhering to international standards for medical device testing. There's no mention of country of origin for specific "data" in the sense of clinical patient cohorts, as this is pre-market notification based on substantial equivalence, not a clinical trial. The study is prospective in the sense that these tests were performed explicitly for this submission.

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

• This is Not Applicable (N/A) for this type of medical device submission. Ground truth, in the sense of expert consensus on diagnostic imaging or clinical outcomes, is not relevant here. The "ground truth" for material properties is established through standardized laboratory measurement techniques and validated analytical chemistry methods, performed by trained lab personnel, not "experts" establishing a consensus.

4. Adjudication Method for the Test Set

• This is Not Applicable (N/A). Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of medical data. For contact lens material testing, there isn't typically such a process; measurements are objective and quantitative.

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

• This is Not Applicable (N/A). This submission is for a physical medical device (contact lenses), not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and AI performance metrics are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is Not Applicable (N/A). As stated previously, this is a contact lens submission, not an AI/ML algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for this submission consists of:
  • Physicochemical Measurements: Objective, quantitative data obtained through validated laboratory testing methods (e.g., refractometry for refractive index, Dk measurement for oxygen permeability, gravimetric analysis for water content, spectrophotometry for light transmittance, etc.). These methods are the 'ground truth' for material properties.
  • Biocompatibility Testing: Results from standardized biological safety tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity Tests) according to ISO or FDA guidelines, which confirm the material is non-toxic and non-irritating.
  • Shelf-life Testing: Stability and sterility testing over time to ensure the device remains safe and effective until its expiration date.

8. The Sample Size for the Training Set

• This is Not Applicable (N/A). There is no AI/ML model involved here, hence no "training set."

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

• This is Not Applicable (N/A). No training set exists for this type of device submission.

Ask a specific question about this device