(169 days)
The DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are indicated for daily wear in the correction of vision acuity in aphakic and for not-aphakic person with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.
The DuraSoft® 3 UV Spherical (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopter (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.
The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. Additional information is available in the Wearing Schedule Section of the package insert, patient instruction and fitting quide. The lenses may be disinfected using a chemical disinfection system.
The DuraSoft® 3 UV (pherical and Optifit Toric hydrophilic contact lenses in Clear, Colors, Complements and Handling Tint are hemispherical shells of the lens material (phemfilcon A). A hydrophilic copolymer of 2-hydroxyethy) methacrylate and 2-ethoxyethyl methacrylate.
The DuraSoft® 3 UV Optifit Toric Contact lenses and DuraSoft® 3 UV (phemfilcon A) Spherical Contact Lenses are made by adding the UV absorber and carbazole violet in-monomer tint to the monomer mixture. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configuration.
The provided document is a 510(k) summary for contact lenses and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the way typically expected for medical devices involving algorithmic performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
However, based on the content available, here's a breakdown interpreting the request in the context of this document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with quantitative targets for performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" are implied to be that the new device's physical, optical, and chemical properties, as well as final lens specifications, are identical or equivalent to those of the previously approved predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical properties are identical to the original opaque tint process. | Demonstrated in pre-clinical toxicology and compatibility studies. |
| Optical properties are identical to the original opaque tint process. | Demonstrated in pre-clinical toxicology and compatibility studies. |
| Chemical properties are identical to the original opaque tint process. | Demonstrated in pre-clinical toxicology and compatibility studies. |
| Final lens specifications are equivalent to lenses approved for the opaque tinting process. | Demonstrated in pre-clinical toxicology and compatibility studies. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "pre-clinical toxicology and compatibility studies." It does not specify the sample size for these studies, nor does it provide information about data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies were pre-clinical toxicology and compatibility studies, which typically involve laboratory testing and not human expert-driven ground truth establishment in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the "test set" in this context refers to pre-clinical testing, not human-read diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable/not provided. The device is a contact lens, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. The device is a contact lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the pre-clinical studies would be established through scientific measurement and analysis of the physical, optical, and chemical properties of the contact lens material and the finished lenses, compared to established benchmarks or the predicate device. This is a scientific and laboratory-based ground truth, not expert consensus or pathology in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" in the context of contact lens material and design testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no training set for this device.
Study Proving the Device Meets the Acceptance Criteria:
The document states: "A thorough series of pre-clinical toxicology and compatibility studies demonstrates that all physical, optical and chemical properties for the handling tint are identical to the original opaque tint process and the final lens specifications are equivalent to the lenses approved for the opaque tinting process."
This statement is the summary of the study proving substantial equivalence. The details of these "pre-clinical toxicology and compatibility studies" (e.g., specific tests, methodologies, results, sample sizes) are not included in this 510(k) summary, but are referred to as the evidence for meeting the implicit acceptance criteria of identity/equivalence. The outcome is that the FDA determined the device to be "substantially equivalent" to predicate devices.
§ 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.