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Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement. The contact lens may be disinfected using a chemical (not heat) disinfection system only.

Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Contact lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam-sterilized in a validated autoclave.

Here's a breakdown of the acceptance criteria and study information for the Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense that would typically be found for a new, independent safety/efficacy study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests and a clinical summary. The "acceptance criteria" are implicitly met if the device's performance is comparable to or meets the established safety and effectiveness profile of the predicate devices.

• "all the procedures were in generally stable condition without severe complication."
• "No significant side effects and complaints to be observed."
• Indicated for correction of visual acuity in non-aphakic persons with non-diseased eyes (myopia/hyperopia) and astigmatism up to 2.00 diopters. |
  | Technological Characteristics | - Equivalent and comparable to predicate lenses in:
  • Diameter range: 13.8 to 14.2 mm
  • Power range: +6.00D to -12.00D
  • Center thickness: 0.08 to 0.12 mm for -3.00D
  • Refractive index: 1.407 (hydrated)
  • Light transmittance: >93%
  • Water content: 56 to 60 %
  • Oxygen permeability (edged corrected): 24x10-11 [(cm³/sec)(ml O2/ml-mmHg)] @ 35°C |
    | Biocompatibility | - Non-toxic and non-irritated (rabbit eye irritation and systemic toxicity studies).
• Not cytotoxic (cytotoxicity testing). |
  | Microbiology | - Steam sterilization process validated to deliver minimum SAL of 10-6.
• Shelf-life stability data supports sterility through expiration date. |
  | Leachability | - No leachable monomers and addictive residues detected above reported levels. |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 65 human eyes
• Data Provenance: The study was conducted for 6 months. It also states that "Discon lenses have been wide-used around the world, including Taiwan, China, Europe, etc." and observations were made "Among the users being daily worn the Discon lenses". This suggests a combination of a prospective clinical study involving 65 eyes and potentially retrospective observations from wider market use, though the details of the latter are not specified as a formal study. The primary clinical study of 65 eyes provides prospective data. The submitter is based in Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth in the clinical study. It mentions the "eye care practitioner may prescribe the contact lens" in the 'Indications for Use', implying practitioners would be involved in patient assessment and data collection.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method for the test set (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This device is a contact lens, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is a contact lens, not a computational algorithm.

7. The Type of Ground Truth Used:

The ground truth for the clinical study seems to be based on clinical observation, patient feedback, and standard ophthalmological assessments of visual acuity and ocular health. Terms like "participants' vision was corrected," "satisfied with the lens wearing," "stable condition without severe complication," and "no significant side effects and complaints" indicate this. For the non-clinical studies (biocompatibility, microbiology, leachability), the ground truth is established through laboratory testing and established scientific methodologies/standards.

8. The Sample Size for the Training Set:

This document does not mention a training set in the context of device development or clinical validation, as it is not an AI/machine learning device. The 65 human eyes mentioned are for the clinical study/test set.

9. How the Ground Truth for the Training Set was Established:

This question is not applicable as there is no mention of a training set for this type of device.

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