(143 days)
The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibility tinted) Is Indicated for dally wear for the correction of refractive ametropia (myopla and hyperopia), presbyopia and astigmatism In aphakic and non-aphakic persons with non-diseased eyes.
Eyecare practitioners may prescribe the lens for dally wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and methacrylic acid crosslinked with EGDMA, which yield the appearance of lenses, which are designed to fit over the corneal surface of the eyc. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refi action of functional conditions of the eye including myopla (nearsightedness), hyperopia (farsightedness), presbyopia and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which It Is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Spherical and aspheric curves as well as beveled edge configurations are built into the lens for alding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PolyVue 43™ contact lenses:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable "acceptance criteria" in the sense of performance thresholds to be met by the device itself in a clinical trial or benchmark study. Instead, the "acceptance criteria" are implied by showing the PolyVue 43™ device's properties are "substantially equivalent" to the predicate device, Specialty T Toric.
| Parameter | Predicate Device Performance (Specialty T Toric) | PolyVue 43™ Performance | Acceptance Criteria (Implied) |
|---|---|---|---|
| Material | ocufilcon A | ocufilcon A | Same material |
| Indication for Use | myopia, hyperopia, astigmatism | myopia, hyperopia, presbyopia, and astigmatism | Broadly similar indications, with PolyVue adding presbyopia. This is justified by equivalence to other marketed presbyopic lenses. |
| Water Content | 44.1% | 43% | Within acceptable range for "substantially equivalent" |
| Light Transmittance | 98.493 | 98.513 | Very similar values |
| Dk (35°C) | $11.267 X 10^{-11}$ | $11.340 X 10^{-11}$ | Very similar values |
| Modulus | 35.96 g/mm² | 36.50 g/mm² | Very similar values |
| Tensile Strength | 33.98 g/mm² | 34.68 g/mm² | Very similar values |
| Elongation @ Break | 165.27% | 169.26% | Very similar values |
| Toughness | 31.8488 g/mm² | 31.9668 g/mm² | Very similar values |
| Color | clear | clear and visibility tinted | Addition of visibility tint is presented as a minor difference, falling within general controls. |
| Refractive Index | 1.427 | 1.427 | Identical |
| Powers | -20.00 to +20.00 D | -20.00 to +20.00D | Identical range |
| Biocompatibility | (Implied by predicate) | Non-toxic | Satisfy cytotoxicity, systemic injection, eye irritation tests. |
| Compatibility with lens care | (Implied by predicate) | Compatible | Compatible with standard lens care regimens (same lens group). |
| Preservative Uptake/Release | (Implied by predicate) | N/A | Same surface electric charge as predicate; no additional studies needed. |
| Leachability of color additives and residual monomers | (Implied by predicate) | Within acceptable limits | Within acceptable limits. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" in the context of clinical performance data in human subjects for the PolyVue 43™ device itself, as it relies heavily on substantial equivalence to the predicate device.
- Physical, Optical, and Chemical Properties: The reported values (water content, Dk, modulus, etc.) are likely derived from laboratory testing of the device material and finished lenses. The sample sizes for these tests are not provided, nor is the data provenance in terms of specific laboratories or countries of origin.
- Biocompatibility and Material Testing: The text mentions "Cytotoxicity Test," "Systemic Injection Test," "Eye Irritation Test," "Compatibility Testing," "Preservative Uptake and Release," and "Leachability of color additives and residual monomers." These are laboratory-based tests. The sample sizes for these specific tests are not provided. The data provenance is implied to be Optech, Inc. internal testing or testing by contract labs.
- Manufacturing Verification: "We have also included in this submission the results of 10 multifocal lenses, manufactured to variety of prescribed specifications to verify ability of the manufacturer to make these lenses." This is a very small sample size for manufacturing verification, not a clinical test set. The provenance is internal manufacturing.
In summary, there is no clearly defined clinical "test set" or data provenance from patient studies provided in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided as the submission does not detail a clinical study with human subjects requiring ground truth established by experts. The "ground truth" for the physical and chemical properties would be established by validated laboratory measurement methods.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as there is no described clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done or described. This type of study is more common for diagnostic imaging devices where human readers interpret results. For contact lenses, the primary focus is on physical and chemical properties, biocompatibility, and safety/effectiveness in patients, often through clinical trials if substantial equivalence cannot be fully demonstrated based on material and design. In this case, no clinical trial data are presented.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
This concept is not applicable here. "Standalone performance" or "algorithm only" refers to artificial intelligence/machine learning devices. The PolyVue 43™ is a physical medical device (contact lens), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the claims in this submission primarily relies on:
- Laboratory Measurements: For physical, optical, and chemical properties (e.g., water content, Dk, modulus).
- Standardized Biocompatibility Tests: For cytotoxicity, systemic injection, eye irritation, etc., which have predefined pass/fail criteria.
- Predicate Device Equivalence: The foundation of the 510(k) process, where the "ground truth" for safety and effectiveness is largely drawn from the known performance and regulatory history of the legally marketed predicate device (Specialty T Toric).
8. The Sample Size for the Training Set
There is no mention of a training set in the context of artificial intelligence or machine learning. For contact lenses, the "training" would refer to the development and refinement of manufacturing processes and material science, rather than an AI training set.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the development of medical devices generally involves extensive pre-clinical research, material science, engineering principles, and adherence to relevant standards and regulations.
§ 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.