(63 days)
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When placed on the human cornea, the OPTIMUM GP rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.
OPTIMUM GP Contact Lens for Daily Wear is available with a plasma surface treatment. Lenses are packaged non-sterile and shipped in one of the following GP solutions.
| Solution | Manufacturer |
|---|---|
| Boston Simplus | Bausch & Lomb |
| Unique Ph | Alcon |
| Optimum CDS | Lobob Laboratories |
The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.
The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.
The provided document describes the modification of an existing contact lens product (OPTIMUM GP) to include a plasma surface treatment, and a UV blocker. The 510(k) summary focuses on demonstrating substantial equivalence to the predicate device.
The document does not contain acceptance criteria for a device's performance based on objective metrics (like sensitivity, specificity, accuracy) for a diagnostic algorithmic device. Instead, it focuses on the technological characteristics and physical properties of a medical device (contact lens) and demonstrates that a modified version maintains substantial equivalence to an existing predicate device.
Therefore, many of the requested points regarding acceptance criteria, study details, and ground truth for an AI/algorithmic device are not applicable or cannot be extracted from this document.
However, I can extract the relevant information concerning the device's characteristics and the comparison made.
Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:
1. A table of acceptance criteria and the reported device performance
As mentioned, this document does not present acceptance criteria in terms of clinical performance metrics for an algorithm. Instead, it focuses on the physical and chemical characteristics of the contact lens. The "performance" assessment is around the reduction in contact angle after plasma surface treatment, indicating improved wettability.
| Characteristic / Acceptance Criteria (Implied) | Reported Device Performance (Modified Device) |
|---|---|
| Intended Use | Indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia. |
| Functionality | Acts as a refractive medium to focus light rays from near and distant objects on the retina. |
| Production Method | Lathe-cut |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate |
| USAN Name | roflufocon |
| Water Content | 98% average blocking |
- UVA (316-380mm): 95% average blocking |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is for a medical device (contact lens) and is focused on demonstrating substantial equivalence through physical and chemical property comparisons and, for the plasma treatment, a lab-based assessment of wettability (contact angle). No clinical "test set" in the context of an AI algorithm is described. The contact angle measurements would have involved a sample size of lenses, but this specific number is not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert-established ground truth for an algorithmic output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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. This is not an AI/algorithmic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical characteristics, the "ground truth" would be established by standard analytical and material testing methods (e.g., spectrophotometry for UV blocking, goniometry for contact angle, chemical analysis for material composition). For the intended use and functionality, it relies on established clinical understanding of contact lens optics and patient outcomes, which are not detailed in this submission as it's a modification to an already cleared device.
8. The sample size for the training set
Not applicable. This is not an AI/algorithmic device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithmic device.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.