(48 days)
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.75 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, astigmatisam and presbyopia. The Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. It is supplied in a sterile package with buffered saline solution.
The provided text describes a 510(k) premarket notification for a soft contact lens, which means the device (Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens) is being compared to a legally marketed predicate device (Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens, K042824). In this context, the acceptance criteria are generally that the new device is "substantially equivalent" to the predicate device in terms of safety and effectiveness, based on comparable technological characteristics and non-clinical performance data.
Here's an breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly that the Largan U38 contact lens's characteristics and performance are comparable to the predicate device (Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens). The "Reported Device Performance" in this case refers to the characteristics and non-clinical test results of the Largan U38 lens, which were presented to demonstrate this comparability.
| Characteristic / Test | Acceptance Criteria (Predicate Device K042824) | Reported Device Performance (Largan U38) | Outcome / Comparability |
|---|---|---|---|
| Material | Polymacon | Polymacon | Same |
| Classification | Group I (Nonionic, Low water) | Group I (Nonionic, Low water) | Same |
| Water Content | 38% (97% | 90% | Comparable |
| Blue handling tint | C.I. Reactive Blue #4 | Reactive Blue 247 | Different formulation, but for same purpose (handling visibility) |
| Method of Manufacture | Cast Molded | Cast Molded | Same |
| Oxygen permeability, refractive index, water content, polymerization residuals, modulus, tensile strength, elongation to break, toughness, sterility, and shelf-life tests | Within established specifications for predicate (implied via K042824 clearance) | Within established specifications for the lenses (Largan U38) | Acceptable |
| Toxicology (Cytotoxicity, ocular irritation, systemic toxicity for material and packaging) | Non-toxic, biocompatible (implied via K042824 clearance) | Non-toxic, biocompatibility acceptable | Acceptable |
2. Sample size used for the test set and the data provenance
The document indicates that no clinical data was required for the Largan U38 contact lens because "The lens material is the same as Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824)." This implies that the "test set" for proving substantial equivalence primarily relied on non-clinical tests comparing the physical, chemical, and optical properties of the Largan U38 lens to established standards and the predicate device.
- Sample Size for Non-Clinical Tests: Not explicitly stated for each test, but typically these involve a sufficient number of units to demonstrate reproducibility and meet statistical requirements for the specific ISO standards cited (e.g., ISO18369-2, ISO18369-3, ISO18369-4, ISO11987, ISO17665-1, ISO17665-2).
- Data Provenance: The manufacturing company is Largan Medical Co., Ltd. located in Taichung, Taiwan, so the non-clinical test data would originate from their facilities or contracted labs, likely in Taiwan. The data is reported in the context of a 510(k) submission, confirming it's a prospective submission of data collected for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical studies were performed for the Largan U38, there isn't a "ground truth" established by external experts in the traditional sense of clinical trial adjudication (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would be the accepted scientific and engineering standards (e.g., ISO standards) and the performance characteristics of the legally marketed predicate device.
- Experts: The expertise would reside in the engineers and scientists performing the non-clinical tests and the regulatory reviewers at the FDA. The FDA's Ophthalmic and Ear, Nose, and Throat Devices panel would review the submission. No specific number or qualifications of "experts establishing ground truth" are detailed as would be for a clinical study.
4. Adjudication method for the test set
No formal adjudication method (like 2+1 or 3+1 consensus) is described because no specific clinical test set requiring expert interpretation or consensus was performed for the Largan U38's substantial equivalence determination. The assessment was based on comparing the non-clinical test results against predefined specifications and the predicate device's characteristics.
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 submission is for a medical device (contact lens), not an AI/CAD system. Therefore, no MRMC study or AI-assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a medical device (contact lens), not an AI algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence for the Largan U38 contact lens was primarily:
- Established scientific and engineering specifications: Adherence to relevant ISO standards (e.g., ISO18369, ISO11987, ISO17665).
- Predicate device characteristics: The established safety and effectiveness profile of the legally marketed Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824).
- Non-clinical test results: Data from physical, optical, chemical, and sterility tests performed on the Largan U38.
- Material composition: The fact that the lens material (Polymacon) is identical to the predicate device was a key factor in waiving clinical studies.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this contact lens submission, as it's not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.