(29 days)
The Visionary Optics Scleral Contact Lens for daily wear is 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 from infection or trauma.
The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex. Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.
Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) 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 Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon B, or tisilfocon A.
I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and device performance. The document is a 510(k) summary for a contact lens, primarily focusing on its substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria, sample sizes, expert qualifications, or adjudication methods for performance evaluation.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- No explicit Acceptance Criteria: The document mentions that lenses were manufactured to "established finished product specifications within the ANSI Z80.20 tolerance" for bench testing, and bioburden testing had an "established acceptance criteria of less than 100 CFU per lens." However, it does not provide a comprehensive table of acceptance criteria for the overall device performance as per your request (e.g., visual acuity, comfort, etc.).
- No detailed Device Performance Results: While it states that manufacturing verification testing demonstrated the ability to manufacture lenses "to a variety of prescribed parameters" and bioburden testing was "within the established acceptance criteria," it does not provide specific numerical results or a comparative performance table against a set of acceptance criteria.
- No information on Test Set Sample Size and Data Provenance: The document does not specify the sample size used for any performance testing, nor does it provide information about the country of origin or whether the data was retrospective or prospective.
- No information on Experts for Ground Truth: There is no mention of experts, their number, or qualifications used to establish ground truth for any testing described.
- No Adjudication Method: The document does not describe any adjudication methods used for a test set.
- No MRMC Comparative Effectiveness Study: The submission primarily relies on substantial equivalence to predicate devices and general claims of safety and effectiveness, not a multi-reader multi-case comparative effectiveness study with AI assistance.
- No Standalone Performance (AI-specific): This device is a contact lens, not an AI algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.
- No Ground Truth Type (for performance studies): Since detailed performance studies with ground truth are not presented, this information is not available. The "ground truth" for a contact lens would typically involve clinical measurements by optometrists/ophthalmologists, patient feedback, and objective physiological responses, but these are not quantified or described in the provided text.
- No Training Set Sample Size or Ground Truth Establishment for Training Set: As this is not an AI device, the concepts of training sets and their ground truth establishment are not applicable here.
The section under "VII. PERFORMANCE DATA" explicitly states:
- "Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A has been addressed by reference to previous 510(k) clearances."
- "Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A with the labeled indications for use has been addressed through previous 510(k) clearances."
This indicates that extensive new performance studies were not conducted for this specific 510(k) clearance, but rather reliance on prior clearances for similar materials and designs. The only specific tests mentioned are:
- Bench Testing: Manufacturing verification to ensure lenses meet ANSI Z80.20 tolerance for established finished product specifications. No specific results table or acceptance criteria other than "within the ANSI Z80.20 tolerance" are provided.
- Bioburden Testing: Demonstrated "colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens."
Therefore, I cannot extract the level of detail you are requesting from this document.
§ 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.