(98 days)
The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The Tangible Hydrogel with Tangible Polymer (etafilcon A) TORIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who may have 5.00 D or less of astigmatism.
The Tangible Hydrogel with Tangible Polymer (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism.
Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available in an aspheric design and manufactured using the castmolding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization.
The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lenses are available in a light blue tint ([Phthalocvaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 nm), and less than 30% in the UVA range (316 to 380nm).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (etafilcon A) soft hydrophilic contact lens has an aspheric back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The lenses are supplied sterile in blister packages containing a buffered saline solution. Package labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for clinical performance in a tabular format as one might find for a diagnostic AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance of the new device is compared to these predicates across various characteristics to demonstrate similarity.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Tangible Hydrogel with Tangible Polymer) |
|---|---|---|
| Material/Functionality | Similar material properties (etafilcon A) and intended function as predicate devices. | Metafilcon A contact lens, acts as a refractive medium. |
| Water Content | 58% (UNICON and Saview-Aqua predicates) | 58% |
| Oxygen Permeability | $30.8 \times 10^{-11}$ (UNICON) and $26.3 \times 10^{-11}$ (Saview-Aqua) (cm2/sec) (ml O2/ml-mmHg) | $29.96 \times 10^{-11}$ (cm2/sec) (ml O2/ml-mmHg) |
| Color | [Phthalocyaninato(2-)]copper (UNICON), Pigment blue 15 (Saview-Aqua) | [Phthalocyaninato(2-)]copper |
| UV Blocking | Yes (Both Predicates) | Yes |
| Production Method | Cast-Molded (Both Predicates) | Cast-Molded |
| Indications | Similar indications for correction of ametropia/presbyopia, daily wear/disposable. | Daily disposable, Aspheric, Toric, Multifocal designs for ametropia and/or presbyopia. |
| Safety & Effectiveness | Non-toxic, non-irritating, sterile for shelf-life, consistent physical/material properties. | Demonstrated via non-clinical testing. |
| Clinical Performance | Established clinical performance (through predicate device testing). | Established previously through clinical performance testing (referencing predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a separate "test set" sample size for the new device as no independent clinical study was conducted for the device's clinical performance. Instead, it relies on the established clinical performance of the predicate devices.
- Data Provenance: The non-clinical testing (toxicology, biocompatibility, sterility, shelf-life, physical/material properties) was conducted in various laboratories under Good Laboratory Practice (GLP) regulations and scientific protocols. The document does not specify the country of origin for these labs.
- The clinical effectiveness is established by referencing previous clinical performance testing of the etafilcon A material, which means the data provenance for clinical performance is tied to the previous studies of the predicate devices. This indicates a retrospective reliance on existing data rather than a new prospective clinical study for this specific device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided because no independent clinical study was conducted for this specific device to establish new ground truth. The submission relies on the established clinical performance of the predicate devices. Therefore, there's no mention of experts establishing ground truth for a new test set in this document.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set with adjudicated ground truth was utilized for this device submission. The device's clinical effectiveness is based on the established performance of the predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This device is a contact lens, not an AI or imaging diagnostic device where MRMC studies are typically performed. The purpose of this submission is to demonstrate substantial equivalence to existing predicate contact lenses.
6. Standalone (Algorithm Only) Performance Study
- No standalone performance study was done. This is not an algorithm or AI-based device, so the concept of "standalone performance" for an algorithm doesn't apply. The device itself (a contact lens) is the product.
7. Type of Ground Truth Used
The "ground truth" for the device's safety and effectiveness relies on:
- Non-clinical testing results: These include laboratory measurements (e.g., water content, oxygen permeability), cytotoxicity, irritation, and sterility tests. These tests are the "ground truth" for the device's material properties and initial safety.
- Clinical performance established by predicate devices: The document states, "The safety and effectiveness of finished contact lenses manufactured from the etafilcon A material have been established previously through clinical performance testing." This implies that the clinical "ground truth" for this material's performance was established through past clinical trials associated with the predicate devices (e.g., UNICON and Saview-Aqua). This would typically involve patient outcomes, visual acuity measurements, comfort assessments, and adverse event reporting from those prior studies.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device (contact lens), not an AI algorithm trained on a dataset. Therefore, there's no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of 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.