(55 days)
The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. 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 (roflufocon A, B, C, D & E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methvi methacrylate. 1.1.3.3.3 - Hexafluoroisopropyl Methacrylate. Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrviic acid cross-linked with Ethylene Glycol Dimethacrylate. The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are available have as lathe cut contact lenses in clear and tinted versions. 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. In the OPTIMUM GP Contact Lens with UV Blocker, a Benzophenone UV blocker is used to block UV radiation. The UV Blocker is 2,2'-Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315mm and 95% in the UVA range of 316 - 380nm.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria in terms of algorithm-driven performance metrics (like sensitivity, specificity, or reader improvement).
Instead, the document is a 510(k) summary for a contact lens (OPTIMUM GP Daily Wear Contact Lens) seeking additional indications for use. The core of the submission is to demonstrate substantial equivalence to existing predicate devices, implying that the new indications for use do not raise new questions of safety or effectiveness.
Here's a breakdown of the specific points requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not present "acceptance criteria" in the typical sense of quantitative performance metrics for an AI/algorithm driven device. Instead, it focuses on the lens's physical properties and its "substantial equivalence" to predicate devices for its intended use. The closest elements to 'performance' are the physical properties.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (OPTIMUM GP) |
|---|---|---|
| Indication for Use | Management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery in otherwise non-diseased eyes. | The OPTIMUM GP Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. |
| Device Classification | Class II, Daily wear, Rigid Gas Permeable RGP Contact Lens, HQD | Class II, Daily wear, Rigid Gas Permeable RGP Contact Lens, HQD |
| Production Method | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate |
| Water Content | 97%, Light Transmission (tinted): >90%, Wetting Angle: 12°, Specific Gravity: 1.189, Oxygen Permeability (Dk): 26 x 10-11 | |
| ** (roflufocon B)** Refractive Index: 1.4454, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 13°, Specific Gravity: 1.181, Oxygen Permeability (Dk): 46 x 10-11 | ||
| ** (roflufocon C)** Refractive Index: 1.4406, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 6°, Specific Gravity: 1.178, Oxygen Permeability (Dk): 65 x 10-11 | ||
| ** (roflufocon D)** Refractive Index: 1.4333, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 3°, Specific Gravity: 1.166, Oxygen Permeability (Dk): 100 x 10-11 | ||
| ** (roflufocon E)** Refractive Index: 1.4332, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 6°, Specific Gravity: 1.155, Oxygen Permeability (Dk): 125 x 10-11 |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a contact lens seeking additional indications, not an AI/algorithm device that would typically have "test sets" of data for performance evaluation in that manner. The submission relies on material properties and clinical experience with similar devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document does not describe the establishment of ground truth by experts in the context of a "test set" for an algorithm.
4. Adjudication method for the test set:
Not applicable. No "test set" or adjudication method is described for an algorithm performance study.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used:
Not applicable in the context of an algorithm's performance validation. The "ground truth" for the device's safety and effectiveness for the additional indications is implicitly established by the long-standing safe and effective use of the identified predicate devices with the same indications, and the physical/chemical similarity of the OPTIMUM GP lens to those predicates.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm device that uses a "training set."
9. How the ground truth for the training set was established:
Not applicable.
Summary of the Study that Proves Acceptance Criteria are Met (based on the provided text):
The "study" or justification for meeting acceptance criteria for this device is entirely based on demonstrating substantial equivalence to legally marketed predicate devices. The document highlights:
- Identical Indications for Use: The requested indications for use for the OPTIMUM GP lens are the same as those for the predicate devices (Boston ES®, Boston EO®, Boston XO® RGP contact lenses and Dyna Intra-Limbal Lens).
- Similar Device Characteristics: The OPTIMUM GP lens shares critical characteristics with its predicates, including classification (Class II, HQD), production method (lathe-cut), FDA Group # (Fluoro Silicone Acrylate), water content (
§ 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.