(63 days)
The Comforthone™ Keratoconus Aspheric (patlufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.
The Comfort Kone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens material (patfufocon C). The material is a thermoset copolymer derived from fluorosilicone acrylate When placed on the human cornea, the ComfortKone" Keratoconus Aspheric rigid gas monomer. permeable contact lenses act as a refracting medium to focus light rays upon the retina.
The ComfortKone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acury to the keratoconus patient. The ComfortKone" lens design begins with a spherical 4,0 mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then the aspheric curve, which is considered the fitting curve of the lens. The aspheric curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with two junctionless peripheral aspheric curves to maintain alignment.
The provided document is a 510(k) premarket notification for a contact lens, the ComfortKone™ Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel technology. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial for an AI/device with measurable performance metrics like sensitivity, specificity, or reader improvement.
Instead, the document demonstrates equivalence by comparing the new device's characteristics (production method, lens function, material properties) to those of a predicate device.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
-
Cannot be provided in the requested format. The document does not specify "acceptance criteria" for performance metrics like sensitivity, specificity, etc., nor does it report "device performance" in that context. Instead, it compares specific characteristics of the new device to a predicate device to establish substantial equivalence.
The closest we can get to showing "criteria" and "performance" here is by reproducing the "Substantial Equivalence Matrix" from the document, which serves as the fundamental comparison for acceptance:
| Characteristic | ComfortKone Keratoconus Aspheric (New Device) | Predicate Device: ROSE K LENS Keratoconus Aspheric | Acceptance (based on equivalence) |
|---|---|---|---|
| 1.) PRODUCTION METHOD | Lathe-Cut | Lathe-Cut | Met |
| 2.) LENS FUNCTION | Keratoconus management. Refractive medium...compensating for refractive error, including (astigmatism) | Keratoconus management. Refractive medium...compensating for refractive error, including (astigmatism) | Met |
| 3.) RGP MATERIAL | Rigid Gas Permeable (RGP) Fluroperm 30 | Rigid Gas Permeable (RGP) Boston ES | Met (with noted polymer difference) |
| a. Water Content | 93 % | > 84 % | Met |
The acceptance criterion applied here is the demonstration of "substantial equivalence" of these characteristics to the predicate device, which implies that the new device does not raise new questions of safety or effectiveness. The document explicitly states: "Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document is a 510(k) premarket notification for a contact lens seeking substantial equivalence. It does not describe a clinical study with a "test set" of patients or data in the way an AI/software device would. The "data" here refers to the physical and chemical properties of the lens material.
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 / Not provided. There is no "ground truth" establishment by experts on a test set of data as this is a physical medical device (contact lens) seeking substantial equivalence based on material properties and design, not an AI or diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. As there is no test set or human interpretation involved, there is no adjudication method 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 / Not provided. This is not an AI-assisted device. Therefore, no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a physical contact lens, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to the established physical and chemical properties of the new contact lens material and design, and the established safety and effectiveness profile of the predicate device. The document relies on:
- Laboratory measurements of the new device's material properties (e.g., refractive index, light transmission, oxygen permeability, wetting angle, specific gravity, hardness).
- The known performance and safety history of the predicate device (Rose K Lens, K945955).
- Pre-clinical toxicology and manufacturing/chemistry data.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device that requires a training set. The "development" of the device likely involved material science and engineering, not data-driven model training.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set for an AI/ML model, this question does not apply.
§ 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.