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The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in not-aphakic persons with non-diseased eyes.

Eyecare practitioners may prescribe the lens for daily 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 eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and center over the apex of the cornea to provide corrective refraction of functional conditions of the eye including myopia (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 aiding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.

The provided text is a 510(k) Summary for a contact lens device, not a study report for an AI/ML medical device. Therefore, the information requested in the prompt, which is specific to AI/ML device studies and acceptance criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the given document.

The document primarily focuses on establishing substantial equivalence to a predicate device based on material, properties, and indications for use.

Here's what can be extracted from the document in relation to acceptance criteria and device performance, rephrased to fit the context of device characteristics rather than AI model performance:

1. Table of Acceptance Criteria and Reported Device Performance

For contact lenses, "acceptance criteria" are typically defined by the physical, optical, and chemical properties that demonstrate the device is safe and effective and comparable to legally marketed predicate devices. The "reported device performance" are the measured values for these properties.

Study that proves the device meets the acceptance criteria:

The document states that the PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) is substantially equivalent to a previously cleared device (K953807), which serves as the "study" or justification for meeting acceptance criteria.

The substantial equivalence is argued based on:

• Identical material (methafilcon A), implying identical biocompatibility.
• Similar intended use and target population.
• Equivalent physical, optical, and chemical properties (as shown in the table above).
• Labeling modifications only for the color additive, following FDA's guidance document.
• Manufacturing methods: While an alternative manufacturing method (molded button with lathe-cut front surface) is introduced, it is stated that "The process shall be validated to demonstrate that the finished product is equivalent to a standard lathe cut lens. Samples will be periodically taken to continually assure that the finished lens specifications are complied with." This describes the validation plan rather than completed study results within this summary.

The remaining points (2-9) are not applicable to this document as it does not describe an AI/ML device study.

2. Sample size used for the test set and the data provenance: Not applicable. This is a contact lens submission, not an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for contact lenses is established through material characterization, clinical trials for safety and effectiveness (which this 510(k) references by substantial equivalence to an already cleared device), and adherence to manufacturing specifications.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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