(241 days)
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00 D of astigmatism or less. The lenses are available with a visibility-handling tunt or with a decorative tint intended to enhance or alter the apparent color of the eve.
Eyecare practitioners may prescribe the contact lens for frequent wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
The SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 38% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA), which was cross-linked with ethyleneglycol dimethacrylate (EGDMA) via UV photo-polymerization.
The SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is tinted blue using Reactive Blue Dye #19 to make the lenses more visible for handling. The cosmetically tinted lens is tinted in an annular pattern, providing a clear optic zone. The lens is colored with one or more of the following "list" color additives: iron oxides (red), titanium dioxide, C.I. Pigment green 7, C.I. Reactive blue 19, D&C Yellow 10 and Phthalocyaninato(2-) copper. The lens is available in the following colors: BLACK, BLUE, GRAY, GREEN, BROWN, PINK, and VIOLET. The lens is supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
The provided text describes the 510(k) premarket notification for the "SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens." It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a standalone study with specific performance metrics.
Therefore, many of the requested categories for AI/algorithm-based device studies are not applicable to this submission, as it concerns a physical medical device (contact lenses) and relies on established standards for material and design equivalence.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present acceptance criteria in the format of specific sensitivity/specificity, accuracy, or other performance metrics usually associated with AI/algorithm devices. Instead, it relies on demonstrating comparable physicochemical properties, biocompatibility, and intended use as legally marketed predicate devices.
The table below summarizes the comparison to predicate devices, which serves as the "performance" data in this context for demonstrating substantial equivalence:
| Characteristic | SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens | EZvue (Polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (Predicate) | Natural Touch (polymacon) Soft (hydrophilic) Contact Lens (Predicate) | ACUVUE 2 COLOURS Brand (etafilcon A) Contact Lens with UV blocker (Predicate) |
|---|---|---|---|---|
| Material (USAN name) | Polymacon | Polymacon | Polymacon | Etafilcon A |
| Indication for use | Correction of refractive ametropia | Correction of refractive ametropia | Correction of refractive ametropia | Correction of refractive ametropia |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded | Cast Molded |
| Water Content | 38% | 38% | 38% | 58% |
| Light Transmittance | >93% | >93% | >97% | >70% |
| Dk (35 °C) | $11 x 10^{-11}$ | $9 x 10^{-11}$ | $8 x 10^{-11}$ | $21.4 x 10^{-11}$ |
| Refractive Index | 1.430 | 1.430 | 1.44 | 1.40 |
| Toxicity | Non-Toxic | Non-Toxic | Non-Toxic | Non-Toxic |
| Color Additives | Iron oxides (red), Titanium Dioxide, C.I. Pigment green 7, C.I. Reactive blue 19, Phthalocyaninato(2-) copper, D&C Yellow 10 | Reactive blue dye #19, aluminum oxide, chromium-cobalt | iron oxides, titanium dioxide, Reactive blue dye 4, Vat orange 1, Phthalocyanine Green, Phthalocyaninato(2-) copper | iron oxides, titanium dioxide |
Acceptance Criteria Implied by Substantial Equivalence: The acceptance criteria for this device are implicitly tied to demonstrating that its material properties, manufacturing process, intended use, and safety profile are substantially equivalent to the identified predicate devices, as supported by physicochemical and biocompatibility testing. There are no explicit quantitative acceptance criteria for performance in the way one would see for a diagnostic algorithm.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as there is no "test set" in the context of an algorithm or AI model development. The evaluation is based on non-clinical laboratory testing of the contact lens material and design, rather than a dataset of patient information. The provenance of the test data is from internal laboratory testing of the "SMART PERFORMER" lens.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth, in the sense of expert annotation of data, is not established for this type of device submission. The "truth" is based on established testing methodologies for contact lens materials and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process for a "test set" is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic or image interpretation device, so a MRMC study is not relevant.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a contact lens (physical device), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is derived from:
- Physicochemical Testing: Measured properties like water content, Dk, refractive index, and light transmittance, compared against the properties of predicate devices.
- Biocompatibility Testing: Results from cytotoxicity, ocular irritation, skin sensitization, and acute systemic toxicity tests, demonstrating non-toxicity and safety, as compared to predicate devices and established standards.
- Clinical History of Polymacon Lenses: The document explicitly states, "Polymacon lenses have been used widely. Their safety and effectiveness have been well documented." This historical data from the "USAN name and process" being the "same as the above mentioned predicate devices" forms a significant part of the safety and effectiveness argument.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI algorithm for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set or associated ground truth establishment process 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.