(38 days)
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-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 is disinfected using a hydrogen peroxide lens care system only.
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be hand painted in an iris or a non-sighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially of lenses with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.
This document is a 510(k) summary of safety and effectiveness for a medical device called "Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear." It's a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.
Here's the breakdown of the requested information, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not contain a table of explicit acceptance criteria or reported device performance in terms of quantitative metrics (e.g., success rates, accuracy, sensitivity, specificity). Instead, it relies on demonstrating substantial equivalence to a predicate device.
The "acceptance criteria" can be inferred from the comparison table, which highlights the similarities in intended use, indications for use, opacity, color additive characteristics, and opaquing agent. The "performance" is implicitly stated as being equivalent to the predicate device, thereby meeting the safety and efficacy standards.
Here's a table summarizing the comparison, which serves as the basis for demonstrating equivalence rather than a set of performance metrics:
| Characteristic | CANTOR & NISSEL Hand Painted PROSTHETIC | Predicate Device: Prosthetic (hefilcon A) Soft Contact Lens ~ K992950 |
|---|---|---|
| Intended Use | Cosmetic Management of conditions such as corneal, iris, or lens abnormalities. | Cosmetic Management of conditions such as corneal, iris, or lens abnormalities. |
| Indications For Use Statement | Indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, in sighted or non-sighted eyes requiring a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. Also prescribed for correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons, or for occlusive therapy for conditions such as diplopia, amblyopia, or extreme photophobia. Disinfected using a hydrogen peroxide lens care system only. | Indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, in sighted or non-sighted eyes requiring a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. Also prescribed for correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons, or for occlusive therapy for conditions such as diplopia, amblyopia, or extreme photophobia. Disinfected with a chemical disinfection system. |
| Opacity | One or more FDA listed color additives | Partially or totally White |
| Color Additive Characteristics | The color additives used are not removed by lens handling and approved cleaning/disinfecting procedures. The optical and performance characteristics are not altered by the lens coloring process. | The color additives used are not removed by lens handling and approved cleaning/disinfecting procedures. The optical and performance characteristics are not altered by the lens coloring process. |
| Opaquing Agent Used | Use of FDA listed reactive dyes in amounts to accomplish desired hand-painted iris patterns. | Titanium Dioxide |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a test set or clinical study with a specific sample size. This 510(k) is based on demonstrating substantial equivalence to an existing device, implying that the safety and effectiveness are established through the predicate's history, not new clinical testing for this specific device model. Therefore, there is no mention of data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no new clinical study or test set requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study or test set is described.
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
Not applicable. This is a contact lens, not AI software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a contact lens, not AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study or test set is described. The "ground truth" for the device's acceptable performance is its substantial equivalence to a previously cleared device.
8. The sample size for the training set
Not applicable. This is a physical medical device (contact lens), not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device (contact lens), not a machine learning algorithm.
§ 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.