(145 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, Salzman'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, fluoroxyfocon 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 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, or fluoroxyfocon A.
The provided FDA 510(k) summary (K233325) for the Visionary Optics Scleral Contact Lens describes non-clinical and clinical studies conducted to support the substantial equivalence claim. However, it does not provide specific acceptance criteria or detailed study results in the format requested. The document primarily focuses on demonstrating equivalence to predicate devices rather than providing a standalone performance validation for a novel device with explicit performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available within the provided text.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|
| Non-clinical: | |
| Ability to manufacture lenses from fluoroxyfocon A blanks to prescribed parameters (manufacturing verification) | All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance. |
| Bioburden (CFU per lens) | Less than 100 CFU per lens. |
| Clinical: | |
| Safety and effectiveness in managing specified ocular conditions (implied: no serious adverse reactions, stable or improved ocular condition and vision) | No serious or significant adverse reactions reported. For all patients, the ocular condition(s) and vision remained stable or improved. |
Explanation: The document does not present specific numerical acceptance criteria (e.g., "X% accuracy," "Y precision"). Instead, for non-clinical studies, it states that manufacturing tolerances were met and bioburden was "within the established acceptance criteria of less than 100 CFU per lens." For clinical studies, the "acceptance criteria" appear to be implied by the outcome: no serious adverse events and stable/improved patient conditions.
2. Sample size used for the test set and the data provenance
- Test set sample size: 33 patients (63 total eyes).
- Data provenance: Not explicitly stated, but the study involved "Nine (9) independent practitioners," suggesting a multi-center, prospective clinical evaluation. The document does not specify the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Nine (9) independent practitioners.
- Qualifications of experts: Not explicitly stated other than "independent practitioners." Their specific specializations (e.g., ophthalmologists, optometrists, or subspecialties) or years of experience are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not described. The text states that "The practitioners reviewed all patients therapeutically managed... and reported the outcome of each patient." There is no mention of an adjudication process among these practitioners for establishing a unified ground truth.
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
- MRMC comparative effectiveness study: No, this document pertains to a medical device (scleral contact lens), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No, this device is a physical contact lens, not an algorithm. The clinical performance inherently involves human fitting and patient use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: The "ground truth" for the clinical study appears to be the observed clinical outcome reported by the independent practitioners, specifically: "no serious or significant adverse reactions reported" and "for all patients, the ocular condition(s) and vision remained stable or improved." This is a form of outcomes data based on clinical observation and assessment by practitioners.
8. The sample size for the training set
- Training set sample size: Not applicable and not mentioned. This is a medical device, not a machine learning model. The "training" described in the context of this submission refers to the historical data and previous 510(k) clearances that establish the safety and effectiveness of the materials used in the lens.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Not applicable and not mentioned. As this is not an AI/ML device, the concept of a "training set ground truth" as you've framed it is not relevant. The safety and effectiveness of the materials (roflufocon D, roflufocon E, etc.) used in the device were established through "reference to previous 510(k) clearances" and "previous 510(k) clearances," implying that historical data and prior regulatory assessments for these materials served as the basis for their use in the current 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.