(48 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 leads 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 Graftversus-Host disease. Sjogren's syndrome, dry eve syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, 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, hyperopia, 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/planned replacement 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) 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 A, or hexafocon B.
The provided document is a 510(k) summary for a medical device, the Visionary Optics Scleral Contact Lens. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than conducting new clinical trials to prove safety and effectiveness from scratch. Therefore, the information typically requested about acceptance criteria and detailed study designs for a new device's performance may not be fully present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense for a new clinical study. Instead, it relies on demonstrating that the physical and material properties of the Visionary Optics Scleral Contact Lens are within established specifications and comparable to predicate devices. The "reported device performance" is largely inferred from meeting these specifications and the substantial equivalence claim.
| Parameter | Acceptance Criteria (Implicit from Tolerances & Predicates) | Reported Device Performance (Visionary Optics Scleral Contact Lens) |
|---|---|---|
| Bench Testing (Manufacturing Verification) | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. | All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance. |
| Bioburden Testing | Less than 100 CFU per lens. | Colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens. |
| Physical Parameters (Example) | ||
| Base Curve | ± 0.2mm | Range: 5.5mm to 25.00mm, Tolerance: ± 0.2mm (Implicitly met) |
| Center Thickness | ± 0.1mm | Range: 0.10mm to 3.00mm, Tolerance: ± 0.1mm (Implicitly met) |
| Diameter | ± 0.20mm | Range: 12.00mm to 26.00mm, Tolerance: ± 0.20mm (Implicitly met) |
| Spherical Power | Various (e.g., ± 0.12 (0 to = 5D)) | Range: -35.00 D to +35.00 D, Tolerances as specified (Implicitly met) |
| Cylindrical Power | Various (e.g., ± 0.25 (0 to = 2D)) | Range: +10.00 D to -10.00 D, Tolerances as specified (Implicitly met) |
| Cylindrical Axis | ± 5° | Range: 1° to 180°, Tolerance: ± 5° (Implicitly met) |
| Bifocal Add | ± 0.25D | Range: +.12 D to +6.00 D, Tolerance: ± 0.25D (Implicitly met) |
| Material Properties (Example - Roflufocon D) | ||
| Refractive Index | - (Compared to predicate) | 1.4333 |
| Light Transmission (clear) | >97% (Compared to predicate) | >97% |
| Water Content | 98% UVB, >95% UVA (Compared to predicate) | >98% UVB, >95% UVA |
Note: The acceptance criteria for many of the physical and material properties are implicit in the comparison to the predicate devices and the fact that the new device states these values. The document asserts that the new device "demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim."
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size for a clinical trial involving human subjects. The non-clinical studies mention "All lenses" for manufacturing verification and "rigid gas permeable lenses manufactured at Visionary Optics LLC" for bioburden testing, implying a representative sample from their production. For clinical evidence, it relies on "a series of clinical case reports" and references previous 510(k) clearances (K033594, K071043, and K071266) for the materials used.
- Data Provenance:
- Non-Clinical (Bench & Bioburden): From Visionary Optics LLC's own manufacturing and testing facility. This is prospective for the purpose of this submission (i.e., new tests performed for this device).
- Clinical: Primarily by reference to previous 510(k) submissions for the lens materials. The "series of clinical case reports" would typically be retrospective, gathering outcomes from actual use of the device. No country of origin is explicitly stated for these case reports or the referenced 510(k) clinical data, but for FDA submissions, it's generally assumed to be U.S. or internationally recognized standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. This is not a study requiring expert-derived ground truth as would be found in a diagnostic AI study. The "ground truth" for the non-clinical tests would be the measured physical properties and bioburden counts. For the clinical case reports, the "ground truth" would be the patient outcomes as documented by the eye care practitioners who prescribed the lenses.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described for the non-clinical tests or the clinical case reports in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging devices involving human readers. For contact lenses, the evaluation focuses on physical parameters, material safety, and clinical performance (patient outcomes), not on the interpretation of images by multiple readers. The submission relies on "substantial equivalence" to predicate devices and existing data for the materials.
6. Standalone Performance (Algorithm Only)
Not applicable. This device is a physical contact lens, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. Type of Ground Truth Used
- Non-Clinical (Bench Testing): Established engineering specifications and measurements (e.g., dimensions, powers).
- Non-Clinical (Bioburden Testing): Microbiological culture results.
- Clinical (Relevant to Referenced 510(k)s and Case Reports): Patient physiological responses, visual acuity, comfort, and other clinical outcomes observed by eye care practitioners.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and manufacturing processes are established based on validated engineering and material science principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an algorithm is involved.
§ 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.