(71 days)
NaturalVue (etafilcon A) Sphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
NaturalVue (etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for single-use disposable wear.
The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibility-tinted, containing a UV blocker and are available in a spherical, aspheric, toric, multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
The provided text is a 510(k) summary for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. This document does not describe a study that uses AI or machine learning to determine performance against acceptance criteria. Instead, it describes non-clinical tests to demonstrate the safety and effectiveness of the contact lenses.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as they relate to AI/ML device evaluations.
However, I can extract the acceptance criteria and reported device performance from the non-clinical studies described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are based on demonstrating substantial equivalence to a predicate device (K140025 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses) and compliance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses. Where specific numerical acceptance criteria are not explicitly stated, the equivalence to the predicate device serves as the implicit acceptance criterion.
| Characteristic | Acceptance Criteria (Implicitly: Equivalent to Predicate K140025 or regulatory standards) | Reported Device Performance (NaturalVue (etafilcon A)) | Meets Acceptance Criteria? |
|---|---|---|---|
| Material Properties | |||
| Production Method | Cast-Molded (per predicate) | Cast-Molded | Yes |
| USAN Name | etafilcon A (per predicate) | etafilcon A | Yes |
| Material Classification | Group 4 high water ionic (per predicate) | Group 4 high water ionic | Yes |
| Water Content (%) | 58% (per predicate) | 58% | Yes |
| Refractive Index | 1.4023 (per predicate) | 1.4023 | Yes |
| Oxygen Permeability | 19.3 x 10-11 (cm²/sec)(ml O2/ml-mmHg) @ 35°C (per predicate) | 19.3 x 10-11 (cm²/sec)(ml O2/ml-mmHg) @ 35°C | Yes |
| % Transmittance at 593nm | > 95% (per predicate) | > 95% | Yes |
| % Transmittance at 380-315nm | -9 for steam sterilization. Sterility maintained through expiration. | Validated to deliver SAL of 10-9. Shelf-life stability supports sterility. | Yes |
| Bacteriostatic Validation | Uniformity of temperature in sterilizer; Tested microorganisms killed. | Demonstrated uniformity of temperature; Tested microorganisms killed. | Yes |
| Shelf-Life | Lenses remain sterile and packages remain tight for claimed expiration. | Lenses remained sterilized with no microbial growth for 4 years (accelerated conditions). Seal remained tight for 4 years (accelerated conditions). | Yes |
| Leachability | No leachable monomers and additive residues at detection levels. | No leachable monomers and additive residues at detection levels. | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML device. For non-clinical material property testing, the sample sizes are not explicitly stated. The biocompatibility, microbiology, and leachability studies were conducted on the predicate device (K140025) and applied to the current device due to substantial equivalence, so the specifics of their sample sizes are not in this document.
Data Provenance: The document refers to the predicate device (K140025), which was submitted by Pegavision Corporation, Taiwan. The current device is from Visioneering Technologies, Inc., and the non-clinical tests were performed to demonstrate equivalence. It's a non-clinical, retrospective comparison to previously established data and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device, and no "ground truth" established by experts for a test set is mentioned.
4. Adjudication method for the test set
Not applicable. No test set requiring expert adjudication is described for this type of device and study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. This is not an AI/ML device, and thus, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device or an algorithm.
7. The type of ground truth used
Not applicable in the context of AI/ML. For the non-clinical tests, "ground truth" would be the established scientific and regulatory standards for contact lens material properties, biocompatibility, sterility, and leachability. For example:
- Material Properties: Direct measurements using laboratory techniques.
- Biocompatibility: Standardized in vitro and in vivo (animal, if applicable, though not specified here) tests.
- Microbiology: Validation of sterilization processes and sterility testing.
- Leachability: Analytical chemistry techniques.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is described.
§ 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.