(210 days)
The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia.
The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA 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.
The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
- cannot be adequately corrected with spectacle lenses
- requires a rigid gas permeable contact lens surface to improve vision
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), 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 a distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.
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 Infinite (tisilfocon A) Daily Wear Contact Lenses are manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process. In the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280mm - 315nm) and >85% in the UVA range (316 - 380nm). The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate 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, D&C Violet No. 2 and D&C Red No. 17. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations.
The provided text describes a 510(k) premarket notification for the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses, which doesn't typically follow the same acceptance criteria and study structure as an AI/ML device. Therefore, the specific questions regarding acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not directly applicable in the conventional sense for this type of device submission.
However, I can extract information related to the device's performance, clinical studies conducted, and the basis for its safety and effectiveness.
Here's an adaptation of the request based on the provided text, focusing on the information available:
1. Table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a contact lens, the "acceptance criteria" are generally based on demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through non-clinical and clinical data. Specific quantitative "acceptance criteria" and "device performance" metrics of an AI/ML device (e.g., sensitivity, specificity thresholds) are not present. Instead, the performance is demonstrated by the absence of serious adverse events and positive clinical outcomes.
| Metric/Criteria | Reported Device Performance |
|---|---|
| Material Properties | |
| Refractive Index (dry) | Uncoated: 1.4378; Tangible™ Hydra-PEG Coated: 1.4398 |
| Light Transmission (@380-780nm) | Uncoated: 91.694; Tangible™ Hydra-PEG Coated: 93.427 |
| UVA Transmission (@316-380nm) | Uncoated: 14.241; Tangible™ Hydra-PEG Coated: 16.105 |
| UVB Transmission (@280-315nm) | Uncoated: 0.011; Tangible™ Hydra-PEG Coated: 0.020 |
| Oxygen Permeability (Dk) (ISO/FATT Method) | Uncoated: $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C); Tangible™ Hydra-PEG Coated: $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |
| Clinical Outcomes (Therapeutic Use) | |
| Incidence of Serious Adverse Reactions | None reported. |
| Ocular Condition Stability/Improvement | For all patients, the ocular condition(s) and vision remained stable or improved during management with the Optimum Infinite (tisilfocon A) scleral contact lenses. |
| Successful Therapeutic Fitting | Successful outcomes for all 115 eyes over a total of 15,017 days. |
| Wettability (with Tangible™ Hydra-PEG coating) | Uncoated Average Sessile Drop Contact Angle: 106.2 degrees (Standard Deviation 5.31); Tangible™ Hydra-PEG Coated Average Sessile Drop Contact Angle: 37.34 degrees (Standard Deviation 5.30). (Significant measurable improvement in wettability) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Study): 62 patients (115 total eyes) were evaluated in the clinical study for therapeutic use of scleral lenses.
- 55 eyes for irregular cornea management.
- 62 eyes for ocular surface disease management.
- Data Provenance: The text does not explicitly state the country of origin of the data. The study appears to be prospective in nature, as practitioners were "instructed to review all patients treated... and to report the outcome." The study followed patients for "at least 3 months" over a "treatment follow-up period."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Six (6) independent practitioners.
- Qualifications of Experts: The specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond "independent practitioners." For contact lens studies, these would typically be ophthalmologists or optometrists experienced in fitting and managing contact lens patients, particularly those with complex conditions like irregular corneas or ocular surface diseases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text does not mention an explicit adjudication method. The independent practitioners reported outcomes, and the overall clinical assessment ("remained stable or improved") was the basis for the conclusion. There's no indication of multiple readers adjudicating cases in the manner described for AI/ML studies.
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:
- No, an MRMC comparative effectiveness study involving AI assistance was not conducted. This is a medical device (contact lens) submission, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a contact lens and does not involve an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is the clinical diagnosis and assessment of therapeutic outcomes by the independent practitioners based on objective and subjective patient data (e.g., vision improvement, stability of ocular conditions, absence of adverse events). It's essentially expert clinical assessment/outcomes data.
8. The sample size for the training set:
- This is not applicable as this is not an AI/ML device that requires a training set in that context. The device's safety and effectiveness are established through non-clinical testing and clinical studies on its material properties and patient outcomes, not through learning from data.
9. How the ground truth for the training set was established:
- Not applicable for the reason stated above.
§ 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.