(30 days)
The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.
The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or notaphakic persons with non-diseased eyes.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
CVUE ADVANCED (hioxifilcon D) soft contact lenses are semi-scleral flexible shells which cover the cornea and may cover a portion of the adjacent sclera and are available as aspheric single vision, multifocal, toric multifocal designs. Torics have a toroidal posterior optic zone, and multifocals have the most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. Torics have the option of dynamic axis stabilization (double slab off) or prism ballast stabilization. All lenses share a base curve with a flattened peripheral curve which approximates the curvature of the sclera. The lens material, (hioxifilcon D), is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2, 3-dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA) and crosslinked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilicon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available with or without a blue visibility handling tint, phthalocyanato (2) -(copper).
The CVUE ADVANCED (hioxifilcon D) soft contact lens is a hemispherical shell of the following dimensions:
Chord diameter: 12.5 to 17.0mm
Center thickness: 0.13 to 0.73; varies with power
Base curve: 7.0 to 10.5mm
Powers: -20.00 to +20.00 diopters
ADD powers (multifocal): Up to +3.00 diopters
Cylinder (toric): Up to 4.00 diopters
Axis (toric): 0° to 180° in 1° steps
Axis stabilization (toric): prism ballast; or dynamic (double slab off)
Optical zone diameters: 5.0 to 10.0mm
The physical/optical properties of the lens are:
Refractive Index 1.408 (hydrated)
Light Transmission – tinted greater than 90%
Water Content 54%
Specific Gravity 1.299 (dry)
Oxygen Permeability (Dk Value) 23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects
This document is a 510(k) Premarket Notification for a contact lens device, not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria, study design, and performance metrics for AI/ML models (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this submission.
The document discusses the substantial equivalence of the C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear to predicate devices based on intended use, manufacturing, safety profile, physical construction, and indications for use. It asserts that the device does not raise any new or different questions of safety and effectiveness.
However, to respond to the prompt's structure where possible, I will extract relevant compliance information assuming a direct mapping, even if the context is different.
Acceptance Criteria and Study for C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens
This document describes the regulatory submission for a contact lens, not an AI/ML medical device. Therefore, the acceptance criteria and study details are related to demonstrating substantial equivalence for a physical medical device. The information provided does not align with the typical data requested for AI/ML device performance.
Here's an attempt to answer the prompt's questions based on the provided text, noting where the information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of quantifiable performance metrics for a study or "reported device performance" in a numerical sense as would be found for an algorithm. Instead, it refers to demonstrating "substantial equivalence" to predicate devices. The "performance" discussed relates to the physical and optical properties of the lens and its "safety and effectiveness" being equivalent to existing devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Intended Use: Device's intended use matches predicate. | "The C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use." |
| Safety Profile: Established safety (pre-clinical toxicology, manufacturing/chemistry data) is equivalent to predicate. | "The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device the same to the CVUE ADVANCED (hioxifilcon D), 510(k) K082853." |
| Physical Construction: Physical construction is equivalent to predicate. | "Physical construction and safety and effectiveness do not change from the predicate devices." |
| Indications for Use: Indications for use are equivalent to predicate. | "The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses indications for use do not change." |
| Manufacturing/Packaging/Sterilization: Procedures are the same as currently marketed devices. | "The device will undergo manufacturing, packaging and sterilization procedures that are the same as devices currently manufactured, marketed and distributed by Unilens Corp., USA." |
| No New Questions of Safety/Effectiveness: Device does not raise new questions. | "This meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise any new or different questions of safety and effectiveness than the predicate devices identified above." |
| Physical/Optical Properties: Meet specified ranges/values. | Refractive Index: 1.408 (hydrated) |
| Light Transmission – tinted: greater than 90% | |
| Water Content: 54% | |
| Specific Gravity: 1.299 (dry) | |
| Oxygen Permeability (Dk Value): 23 x 10^-11 Fatt Units (cm²/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is a 510(k) submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device with a test set of data. The "study" here is a comparison to predicate devices, not clinical trial data with specific patient sample sizes for performance evaluation in the typical sense.
- Data Provenance: Not applicable in the context of an AI/ML test set. The submission refers to a previous 510(k) for the safety profile (K082853), implying existing data from that submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" of data or "ground truth" (as in expert-labeled data for an algorithm) established by experts in this type of submission. The evaluation is based on established regulatory standards and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication related to algorithm performance is present.
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
- Not applicable. This relates to an AI/ML device, which this contact lens is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to an AI/ML device, which this contact lens is not.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" as it applies to AI/ML model training and validation is not relevant here. The "truth" for this submission is regulatory compliance and demonstrating equivalence to legally marketed predicate devices, supported by manufacturing data, physical properties, and a previously established safety profile.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or "ground truth" for it, as this is not an AI/ML device.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.