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510(k) Data Aggregation
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The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear 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 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and 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 55 Toric (ocutilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear 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.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care 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 or hydrogen peroxide disinfecting systems.
The 55 SV, 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The 55 Contact Lens is available in a single vision lens design, the 55 Toric Contact Lens is available in a double slab-off back surface design and the 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (ocufilcon C) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). Lenses are tinted using the color additive Reactive Blue 19.
Acceptance Criteria and Study for United Contact Lens Products
The provided document describes a 510(k) premarket notification for three soft contact lens products: 55 SV, 55 Multifocal, and 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lenses for Daily Wear.
The acceptance criteria for these devices were established by demonstrating substantial equivalence to predicate devices. This means that the new devices have comparable physicochemical properties and do not raise new questions of safety and effectiveness compared to existing, legally marketed devices.
The study proving the device meets acceptance criteria involved pre-clinical tests and physicochemical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: Substantial equivalence to predicate devices (55 F, Toric 55, and Multifocal (ocufilcon C) Soft (hydrophilic) Contact Lenses for Daily Wear) in terms of safety, effectiveness, and physicochemical properties. This is implicitly demonstrated by comparing key material and performance parameters.
| Parameter | Predicate Device Performance (Acceptance Criteria) | Subject Device Performance |
|---|---|---|
| Material | ocufilcon C | ocufilcon C |
| Material Classification | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| Indication for Use | myopia, hyperopia, astigmatism and presbyopia | myopia, hyperopia, astigmatism and presbyopia |
| Water Content | 54.4% | 54.9% |
| Visible Light Transmittance | 98.3% | 98.9% |
| Dk (35° C) | $18.78 \times 10^{-11}$ | $18.77 \times 10^{-11}$ |
| Powers | +20.00D to -20.00 D; Continuous add power to +3.00 (55 Multifocal); Cylinder powers -0.50 D to -6.00D (Toric 55) | +12.00 D to -20.00 D; Continuous add power to +3.00 (55 Multifocal); Cylinder powers -0.50 D to -2.50 D (55 Toric) |
| Color | clear | Blue visibility, Reactive Blue #19 |
| Refractive Index | 1.414 | 1.415 |
| Method of Manufacture | Lathed | Molded |
| Toxicity/Irritation | Non-toxic, non-irritating (implied by predicate history) | Non-toxic, non-irritating (demonstrated) |
| Residue | Safe amounts (implied by predicate history) | No evidence of unsafe amounts (demonstrated) |
| Sterility & Physical Stability | Sterile and stable for shelf life (implied by predicate history) | Remaining sterile and physically stable for shelf life (demonstrated) |
Note: The "Acceptance Criteria" for individual parameters are interpreted as matching or being acceptably close to the predicate device's performance, as the overarching goal is substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for "test sets" in the context of clinical trials with human subjects. Instead, it refers to pre-clinical tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, and residue evaluation) and physicochemical testing. These tests are typically conducted on a representative sample of manufactured lenses and materials, not a "test set" from a typical clinical study.
- Sample Size: Not explicitly stated for each test (e.g., number of lenses, number of animals for in vivo tests). However, the "resulsts showed no evidence of unsafe amounts of residue" suggests a sufficient sample was tested to draw conclusions.
- Data Provenance: The tests described (Systemic Injection, Primary Ocular Irritation, Cytotoxicity Tests, residue evaluation, physicochemical testing, shelf life testing) are laboratory-based and pre-clinical. There is no mention of human clinical data or retrospective/prospective studies on human subjects in this 510(k) summary for establishing substantial equivalence. The data would have been generated internally by United Contact Lens Inc. or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission. The "ground truth" for showing substantial equivalence relies on objective laboratory measurements and established regulatory standards for material safety and performance, rather than expert consensus on a clinical test set. The submission focuses on comparing the new device's technical specifications and safety profile to those of a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable. No adjudication method (like 2+1 or 3+1 often used for image-based ground truth establishment) is mentioned or relevant to the types of pre-clinical and physicochemical tests described.
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 information is not applicable. The device is a contact lens, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. As stated above, the device is a contact lens, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for these contact lenses was based on:
- Objective physicochemical measurements: Comparative data for water content, visible light transmittance, Dk, refractive index, and power ranges against the predicate device.
- Established safety standards: Results from Systemic Injection, Primary Ocular Irritation, and Cytotoxicity Tests indicating non-toxicity and non-irritation, which align with accepted biological safety assessments for medical devices.
- Residue analysis: Demonstrating that extracted lenses have no unsafe amounts of residue.
- Shelf life testing: Confirming sterility and physical stability over time.
These measurements and tests serve as the objective evidence (ground truth) against which the new devices' performance was compared to the legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of developing this medical device. The process involves design, manufacturing, and testing to meet specifications and demonstrate equivalence, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no training set.
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