(167 days)
The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic or not-aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.
The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The EpiCon K Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
Chord Diameter: 10.5 mm to 14.0 mm
Center Thickness: 0.10 mm to 0.35 mm
Base Curve: 6.0 to 8.5 mm
Powers: Plano to -20.00 D
Peripheral Curves: A. B. C. D. E. F and G
Here's the analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document describes a 510(k) submission for a Rigid Gas Permeable Contact Lens (EpiCon K) and focuses on demonstrating substantial equivalence to a predicate device (UltraCon S). As such, the structure of the document does not explicitly present "acceptance criteria" in the format one might expect for a novel AI/software medical device. Instead, it argues that the new device's performance is "within the expected range" and "substantially equivalent" to the predicate, based on a clinical evaluation.
Therefore, the response below adapts the requested categories to fit the information presented in this specific 510(k) summary, interpreting "acceptance criteria" as the performance metrics and expected ranges for a contact lens for keratoconus patients.
Acceptance Criteria and Device Performance for EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Acceptance Criterion - Inferred) | Reported Device Performance (EpiCon K) |
|---|---|
| Incidence of positive slit lamp findings (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Incidence of subject symptoms (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Incidence of problems and complaints (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Keratometry changes (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Refractive changes (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Visual acuity with the lens (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Lens wearing time (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Lens comfort (within expected range for keratoconic eyes wearing RGP lenses) | Within the expected range |
| Adverse reactions | Two reported, both resolved without sequelae upon discontinuation of lens wear. |
| Clinical performance | Substantially equivalent to the predicate lens (UltraCon S Rigid Gas Permeable Contact Lens). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 38 keratoconic subjects were initially dispensed the EpiCon K lens. 18 subjects (47.4%) completed the 4-week study period.
- Data Provenance: The study was a prospective clinical evaluation conducted at five investigational sites, implied to be within the US, as this is an FDA 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not explicitly stated in the provided document. For a clinical study of contact lenses, qualified optometrists or ophthalmologists at each investigational site would have performed the examinations and made clinical judgments, but their specific number, roles in establishing "ground truth," or detailed qualifications (e.g., years of experience) are not provided. The study design implies that clinical observations and measurements from these practitioners served as the data for performance evaluation.
4. Adjudication Method for the Test Set
This information is not explicitly stated. The document mentions that the study was conducted "in accordance with current Good Clinical Practices," which would typically include procedures for data collection and review, but a specific adjudication method (e.g., 2+1) is not detailed. The evaluation likely relied on direct clinical assessments by the investigators at each site.
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 document describes the clinical evaluation of a contact lens, not an AI/software medical device. Therefore, an MRMC study related to AI assistance is not relevant or applicable to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. As noted above, this device is a physical contact lens, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the EpiCon K lens was based on clinical observations, measurements, and patient-reported symptoms by trained ocular health professionals (e.g., optometrists, ophthalmologists) during the 4-week clinical evaluation. This includes:
- Slit lamp findings
- Subject symptom reports
- Complaints/problems
- Keratometry readings
- Refractive measurements
- Visual acuity assessments
- Lens wearing time
- Lens comfort assessments
Comparison was also made against the expected range for keratoconic eyes wearing RGP lenses and against the clinical performance of a predicate device.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device (contact lens) and not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI model, this question is not relevant to the described 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.