(178 days)
Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens 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 single-use daily disposable wear. The Discon Daily Lenses are not intended to be disinfected and should be discarded after a single use.
Discon daily Contact Lens are available as non-spherical fenses 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 Daily Contact lens with visible tint is light 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.
This document is a 510(k) Pre-Market Notification for a contact lens, and it primarily focuses on establishing substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.
Based on the provided text, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Discon Daily) | Predicate Device (Discon K051129) Performance |
|---|---|---|
| Material/Composition | No change from predicate lens material (Etafilcon A, HEMA, MAA, TMPTMA, EGDMA) | Same (Etafilcon A, HEMA, MAA, TMPTMA, EGDMA) |
| Manufacturing Process | No change from predicate lens manufacturing process (spin-casting) | Same (spin-casting) |
| Diameter Range | 13.8 to 14.2 mm | No explicit range given, but implied same as predicate due to no change statement |
| Power Range | +6.00D to -12.00D | No explicit range given, but implied same as predicate due to no change statement |
| Center Thickness (-3.00D) | 0.08 to 0.12 mm | No explicit range given, but implied same as predicate due to no change statement |
| Refractive Index (hydrated) | 1.407 | No explicit value given, but implied same as predicate due to no change statement |
| Light Transmittance | >93% | No explicit value given, but implied same as predicate due to no change statement |
| Water Content | 56 to 60 % | No explicit value given, but implied same as predicate due to no change statement |
| Oxygen Permeability | 24 x 10^-11 [(cm² /sec)(ml 02/ml-mmHg)] @ 35℃ | No explicit value given, but implied same as predicate due to no change statement |
| Clinical Safety | "generally stable condition without severe complication," "no significant side effects and complaints" observed in wide usage. | Supported by prior submission K051129; deemed clinically safe. |
| Efficiency and Security of Use | Indicated to support efficiency and security as well as predicate devices. | Established by predicate device. |
Explanation of the Table:
The document repeatedly states "There is no change in lens material, the manufacturing process, nor the parameter and properties" and "These technological characteristics of Discon Daily Contact lenses do not change to that of predicate lenses previously submitted in K051129." Therefore, the acceptance criteria for these characteristics are implicitly that they are identical to the predicate device, K051129. The reported performance of the Discon Daily is the same as these predicate device characteristics. The only explicit change mentioned is a "slightly exchange of blue-tint concentration," which is not given a specific acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a defined "test set" with a numerical sample size. The document refers to "Discon Daily lenses have been wide-used around the world, including Taiwan, China, etc. Among the users being daily worn the Discon Daily lenses, all the procedures were in generally stable condition without severe complication." This implies a post-market surveillance type of observation rather than a structured clinical trial test set.
- Data Provenance: "wide-used around the world, including Taiwan, China, etc." The nature is observational/retrospective, based on existing usage data rather than a new prospective study for this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No formal "ground truth" establishment by experts for a specific test set is described. The assessment of "generally stable condition without severe complication" and "no significant side effects and complaints" appears to be an aggregation of real-world usage and reporting, rather than an expert panel review of individual cases.
4. Adjudication Method for the Test Set
Not applicable. No formal adjudication method is mentioned as there isn't a structured test set requiring such.
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 device is a contact lens, not an AI/software device, so MRMC studies involving AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a contact lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for showing clinical safety and effectiveness is primarily clinical outcomes/usage data (i.e., observation of "generally stable condition without severe complication" and "no significant side effects and complaints" from wide usage) and equivalence to predicate devices which had previously established safety and effectiveness. There is no mention of pathology or other objective diagnostic criteria as ground truth for a clinical study.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/learning algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
Summary of the Study:
The "study" in this 510(k) submission is not a new clinical trial but rather a demonstration of substantial equivalence to previously cleared predicate devices (K051129 and K013973). The key "study" elements are:
- Assertion of No Change: The core of the argument is that the device (Discon Daily) uses the same material and manufacturing process as a previously cleared device (Discon K051129). This implies that all non-clinical and most clinical performance data for the predicate device directly apply to the new device.
- Technological Characteristics Comparison: The document lists several key technological characteristics (diameter, power, thickness, refractive index, light transmittance, water content, oxygen permeability) and states they "do not change to that of predicate lenses."
- Clinical Data Leverage: The clinical data submitted in the predicate K051129 is leveraged to support the clinical safety of the subject device.
- Real-World Usage Observation: Complementing the equivalence, the document mentions that Discon Daily lenses have been "wide-used around the world" and "all the procedures were in generally stable condition without severe complication" with "no significant side effects and complaints." This serves as real-world observational evidence reinforcing safety.
In essence, for this 510(k), the "study" is a comparative analysis, relying heavily on the established safety and effectiveness of its predicate devices, combined with observational real-world data indicating no new safety concerns.
§ 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.