(23 days)
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted to the eyecare professional instructions.
The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 19, reactive blue 19, reactive blue 4. reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
Tint Patterns Available:
- Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
- Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
- Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
- Tinted lens with Black Pupil. Uses the CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cantor & Silver 5X Prosthetic Tinted Soft Contact Lens:
Acceptance Criteria and Device Performance:
The provided document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for specific performance metrics. Therefore, explicit "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial with quantitative endpoints are not present. Instead, substantial equivalence is claimed based on comparable intended use, indications, and material/manufacturing characteristics.
The table below summarizes the characteristics presented for substantial equivalence. The "Acceptance Criteria" column reflects the implicit criteria for being considered substantially equivalent (i.e., being similar to the predicate device), and the "Reported Device Performance" column reflects the characteristics of the subject device.
| Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Cantor & Silver 5X Prosthetic) |
|---|---|
| Intended Use: Cosmetic Management of conditions such as corneal, iris, or lens abnormalities. (Matching predicate device) | Intended Use: Cosmetic Management of conditions such as corneal, iris, or lens abnormalities. |
| Indication: Comprehensive indications for daily wear, cosmetic management, refractive correction, and occlusive therapy. (Matching predicate device, except for disinfection system) | Indication: Daily wear for enhancing/altering eye color, ocular masking, corneal/iris/lens abnormalities, refractive ametropia correction (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons, occlusive therapy (diplopia, amblyopia, extreme photophobia). Disinfected using hydrogen peroxide only. Frequent replacement program. |
| FDA "listed" colored additives: Use of specified reactive colored additives. (Matching predicate device, but specific additives differ) | FDA "listed" colored additives: Reactive black 5, reactive blue 4, reactive blue 19, reactive 21, reactive blue 163, reactive yellow 15, reactive yellow 86, reactive orange 78, reactive red 11, reactive red 180. |
| Uses and restrictions: Color additives not to exceed minimum required for prosthetic effect. (Matching predicate device) | Uses and restrictions: Color additives not to exceed minimum reasonably required to accomplish the intended prosthetic effect. |
| Color Additive Characteristics: Not removed by handling/cleaning; optical/performance characteristics not altered by coloring. (Matching predicate device) | Color Additive Characteristics: Not removed by lens handling and approved cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process. |
Study Details:
The provided document does not contain information about a specific clinical study with quantitative performance metrics to "prove the device meets acceptance criteria" in the way one might expect for a new device claiming superiority or unique performance. Instead, the submission is based on substantial equivalence to existing legally marketed devices.
Therefore, many of the requested study-specific details are not applicable or explicitly stated in this 510(k) summary.
- Sample size used for the test set and the data provenance: Not applicable. No specific "test set" or clinical study with patient data detailed in this 510(k) summary. The comparison is against characteristics of predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" derived from expert consensus on a test set is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for study data is mentioned.
- 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: Not applicable. This device is a contact lens, not an AI diagnostic tool, so an MRMC study is irrelevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for the substantial equivalence claim would be the established characteristics and regulatory approval of the predicate devices.
- The sample size for the training set: Not applicable. No "training set" is mentioned as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.