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510(k) Data Aggregation
(146 days)
The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross-linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 45.0% HEMA and 55.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.
The provided document is a 510(k) Pre-market Notification for a contact lens, the FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens. It details the device's properties and its substantial equivalence to a predicate device. This type of regulatory submission does not typically include information about studies to prove device performance against acceptance criteria in the same way a software or AI/ML device would.
Instead, for contact lenses, "acceptance criteria" are usually based on demonstrating that the new device has equivalent or better physical, optical, and chemical properties, as well as safety (toxicology, leachable compounds), compared to a previously cleared predicate device. The "study" proving this involves direct comparison of these properties through laboratory testing, rather than clinical trials with human readers or AI performance metrics.
Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size) are not applicable to this type of device and submission.
Here's an attempt to answer the questions based on the provided text, recognizing the different nature of this device type:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to the predicate device, FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear. This is achieved by showing comparable physical, optical, and chemical properties, and acceptable safety profiles.
| Parameter | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (FREQUENCY 55 UV) | Predicate Device Performance (FREQUENCY 55) |
|---|---|---|---|
| Material | methafilcon A | methafilcon A | methafilcon A |
| Indication for use | myopia, hyperopia, astigmatism | myopia, hyperopia, and astigmatism | myopia, hyperopia, and astigmatism |
| Water Content | 55% | 55% | 55% |
| % Transmittance @ 590nm | Comparable to Predicate (>90% specified in description) | 93.58% | 95.47% |
| % Transmittance @ 280-315 nm | Block UV (significantly lower than predicate, <10% specified) | 6.00% | 82.47% |
| % Transmittance @ 316-380 nm | Block UV (significantly lower than predicate, <10% specified) | 4.09% | 95.30% |
| Dk (35°C) (Edge Corrected) | Comparable to Predicate | $14.00 \times 10^{-11}$ | $15.50 \times 10^{-11}$ trending |
| Powers | -20.00 to +20.00 D | -20.00 to +20.00 D | -20.00 to +20.00 D |
| Color | Clear and tinted (differs in tint color but functionally similar) | Clear and aqua visibility | Clear and blue visibility |
| Refractive Index | Comparable to Predicate | 1.4027 | 1.4052 |
| Tensile Strength | Comparable to Predicate | 1.26 | 0.66 |
| Modulus | Comparable to Predicate | 0.32 | 0.48 |
| Elongation at Break | Comparable to Predicate | 287 | 179 |
| Toughness | Comparable to Predicate | 1.27 | 0.38 |
| Manufacturing Method | cast molding | cast molding | cast molding |
| Toxicological Profile | Non-toxic | Demonstrated non-toxic (cytotoxicity, acute systemic, acute ocular) | (Not specified in table, but predicate would have demonstrated safety) |
| Residual Monomer/Color Leach. | No leachable color/significant residual monomers | Demonstrated no leachable color/significant residual monomers | (Not specified in table, but predicate would have demonstrated safety) |
| Sterilization/Packaging | Same as previously cleared devices | Same as K973063 and K971164, sterility released by parametric release. | Same as K973063 and K971164 |
2. Sample Size Used for the Test Set and Data Provenance
For physical, optical, and chemical properties, the "test set" would consist of manufactured lenses subjected to laboratory measurements. The document does not specify the sample size (number of lenses tested) used for these measurements or the exact provenance (e.g., specific manufacturing batches). The data is generated from laboratory testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a contact lens, not a diagnostic device requiring expert interpretation of medical images or data. Ground truth for properties like water content or transmittance is established by direct measurement using validated laboratory methods and instruments, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like "2+1" typically apply to expert review of clinical cases, which is not relevant for the type of testing described for this contact lens.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. MRMC studies are used for evaluating diagnostic performance of systems involving human readers, usually in conjunction with AI. This is not applicable to an optical device like a contact lens.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This device does not involve an algorithm or AI. Its performance is measured directly through laboratory characterization of its physical, optical, and chemical properties.
7. The Type of Ground Truth Used
The ground truth for the device's properties is based on direct laboratory measurement using established scientific methods (e.g., for Dk, transmittance, tensile strength, water content). For safety attributes (toxicology, leaching), the ground truth is established through standard biological and chemical testing protocols.
8. The Sample Size for the Training Set
N/A. There is no "training set" in the context of a traditional mechanical/optical medical device like a contact lens. The device's properties are inherent to its design and manufacturing process, not learned from data.
9. How the Ground Truth for the Training Set Was Established
N/A. As mentioned above, there is no training set for this type of device.
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