(62 days)
The Hydron Biomedics 55 (ocufilcon D) visibility tint soft (hydrophilic) contact lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit astigmatism of 2.00 D or less that does not interfere with visual acuity; it is available in powers from -10 to + 10 diopters.
Eyecare practitioners may prescribe the lens for either single-use disposable wear or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/ planned replacement wear, the lens may be disinfected using a chemical disinfection system.
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients crosslinked with EGDMA and other components 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 cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness) and hyperopia (farsightedness). Each lens provides corrective power which corresponds 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 6 mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.
The provided text is a 510(k) summary for the Hydron Biomedics 55 contact lens. It describes the device, its indications for use, and asserts its substantial equivalence to previously cleared devices. However, it does not contain information about acceptance criteria, detailed study designs, or performance data beyond stating equivalence.
Therefore, I cannot populate the requested table or answer the specific questions about formal acceptance criteria studies. The document focuses on demonstrating equivalence to existing devices rather than presenting novel performance testing against specific criteria for this particular submission.
Here's a breakdown of what is and isn't available related to your request:
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance (no specific performance criteria or data is presented).
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
What the document does indicate is that the device's substantial equivalence is based on:
- Predicate Device: K942214 (tinted daily wear lens of the same material) and PMA P890023/S4 (in-monomer tinted ocufilcon D contact lens for extended wear, currently marketed).
- Material and Manufacturing: The device is "identical to the in-monomer tinted ocufilcon D contact lens approved in PMA P890023/S4" and "manufactured by the same manufacturing process."
- Physical, Optical, and Chemical Properties: Stated to be "equivalent to the clear and identical to the tinted versions of the Hydron Biomedics 55 (ocufilcon D cast molded contact lens."
- FDA Lens Group: Classified as Lens Group IV high-water ionic group as established by the FDA.
In summary, this 510(k) submission relies on demonstrating that the new visibility-tinted contact lens is fundamentally the same as previously approved predicate devices, rather than providing new performance data against a set of acceptance criteria.
§ 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.