(57 days)
The ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) 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 ComfortKone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens materials (hybufocon A, filotocon A, pemufocon A). When placed on the human cornea, the Comfort Keratoconus Aspheric rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.
The Comfort Kone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The ComfortKone™ lens design begins with a spherical 4.0 mm ontic zone that fits the peak of the cone and provides for good visual acuity. The lens then thattens into 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. design finishes with two junctioniess peripheral aspheric curves to maintain alignment.
The provided document is a 510(k) summary for a contact lens, specifically for the addition of three new RGP materials to a previously cleared design and indication for use. The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI-enabled diagnostic devices.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on material properties, manufacturing methods, and intended use. The "acceptance criteria" here are effectively the demonstration of comparable physical characteristics and safety profile to the predicate device.
Therefore, many of the requested sections (sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable to this type of regulatory submission as it's not a de novo device or a performance study for a new diagnostic algorithm.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission for the ComfortKone™ Keratoconus Aspheric Contact Lens (with new materials hybufocon A, filofocon A, and pemufocon A) focuses on demonstrating substantial equivalence to a previously cleared predicate device (ComfortKone™ Keratoconus Aspheric (paflufocon C), K990264). The "acceptance criteria" are implied by the comparative evaluation of various characteristics between the new device and the predicate device. The study to "prove" meeting these criteria is a direct comparison of physical and chemical properties and intended use.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Device Performance) | New Device Reported Performance (hybufocon A, filofocon A, pemufocon A) | Conclusion |
|---|---|---|---|
| INDICATION | Daily wear, RGP contact lens | Daily wear, RGP contact lens | Substantially Equivalent |
| INTENDED USE | Daily wear for keratoconus management and correction of refractive ametropia in non-diseased eyes. | Daily wear for keratoconus management and correction of refractive ametropia in non-diseased eyes. | Substantially Equivalent |
| PRODUCTION METHOD | Lathe-Cut | Lathe-Cut | Substantially Equivalent |
| RGP Material Common Name | Fluroperm 30 (paflufocon C) | HyBrid FS, Hydro2, Accucon | This is the primary difference; the new materials are being added, and their properties are compared for equivalence. |
| Water Content | 93% | (hybufocon A) = >93% | |
| (filofocon A) = >93% | |||
| (pemufocon A) = >93% | Substantially Equivalent | ||
| Refractive Index | 1.47 | (hybufocon A) = 1.44 | |
| (filofocon A) = 1.45 | |||
| (pemufocon A) = 1.45 | Considered substantially equivalent. |
Note: The acceptance criteria are essentially the properties of the predicate device that the new device's properties are compared against for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
This document describes a comparison of material properties, not a clinical "test set" in the sense of patient data. The properties are inherent to the materials themselves. The "study" involves characterizing these materials and comparing them to the predicate. The document doesn't specify sample sizes for material testing, but it's implied that standard material characterization methods were used. There is no information about country of origin for data or whether it's retrospective/prospective in a clinical trial sense. The referenced 510(k) numbers for the raw materials (K021977, K000485, K944223) indicate that the physical properties of these materials were previously characterized and accepted independently.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth for a clinical "test set" is not relevant here as this is a material and design modification submission. The "ground truth" for the material properties would be established through laboratory testing and characterization.
4. Adjudication Method for the Test Set:
Not applicable, as there is no clinical "test set" or diagnostic reading being adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This submission is for contact lens material additions, not a diagnostic imaging device with human-in-the-loop performance evaluation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a contact lens, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" used for this submission is the established physical and chemical properties of the new materials, as well as the design parameters of the ComfortKone™ lens, all compared to the previously cleared predicate device. This is based on laboratory characterization of materials and established manufacturing processes, not expert consensus, pathology, or outcomes data in a clinical sense for this specific submission. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is stated to be equivalent to the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not a machine learning or AI 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.