(25 days)
The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/ lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.
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 Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable™ Rigid Gas Permeable (rofflufocon D, roflufocon E) Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D (supplied by Contamac Ltd.) or roflufocon E (supplied by Contamac Ltd.).
This document is a 510(k) premarket notification for a medical device, specifically a type of contact lens. It outlines the manufacturer's claim that their new device is substantially equivalent to a previously cleared predicate device. This type of FDA submission does not involve the rigorous clinical study design typically associated with proving a device meets specific acceptance criteria for AI/ML-based medical devices.
Therefore, I cannot extract the information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to this particular 510(k) submission for a physical contact lens.
This document focuses on demonstrating substantial equivalence based on comparable:
- Intended Use
- Indications for Use
- Technological Characteristics (materials, design, production method, physical properties)
- Performance Data (which here refers to non-clinical bench testing for manufacturing verification and reference to previously cleared 510(k)s for material clinical safety/effectiveness, not new clinical trials for this specific device).
The "performance data" sections (VII. PERFORMANCE DATA) specifically state that "Non-clinical testing to validate safety and effectiveness for finished contact lenses manufactured from roflufocon D and roflufocon E blanks has been addressed by reference to previously cleared 510(k) premarket notifications" and "Clinical performance data to validate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to previously cleared 510(k) premarket notifications." This confirms that no new standalone clinical studies were performed for this specific submission to define and meet new acceptance criteria.
In summary, the provided document does not contain the information needed to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth, or expert involvement, as it pertains to a traditional medical device (contact lens) seeking 510(k) clearance based on substantial equivalence, not an AI/ML-based medical device requiring such validation.
§ 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.