(53 days)
The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens frequent repacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is available as a single vision lens. The lens material, polymacon is hydrophilic polymer of 2-hydroximethyl methacrylate (HEMA) cross-linked with ethyleneglycol dimethacrylate(62%) and water(38%).
Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is colored with one or a combination of one or more of the following color additives: Titanium dioxide (white), C.I Pigment blue 36, Iron oxides, C.I. Pigment green 7, C.I. Pigment violet 23, D&C Yellow No.10.
Neo Vision Neo Cosmo is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera with the following dimensions:
- Diameter: 13.8mm to 14.5mm
- Base Curve: 8.0mm to 9.0mm
- Center Thickness: 0.05mm to 0.135 (varies with power)
- Powers: 0.00D to -10.00D
The provided document is a 510(k) summary for the Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens, which seeks to demonstrate substantial equivalence to a predicate device. It details non-clinical and pre-clinical testing, but explicitly states that no clinical testing was performed for this device to establish its performance or meet acceptance criteria based on human use.
Therefore, many of the requested categories related to clinical study design, sample size, ground truth, expert adjudication, or human reader effectiveness cannot be answered from this document. The document focuses on demonstrating physical, chemical, and biocompatibility equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format for performance. Instead, it provides a summary of non-clinical and biocompatibility tests that "passed." The substantial equivalence section compares the physical properties and indications for use against a predicate device. Based on the "SUMMARY OF SUBSTANTIAL EQUIVALENCE" table (page 5), the following could be considered performance characteristics and their comparison to the predicate, demonstrating their "acceptance."
| Characteristic | Acceptance Criteria (from Predicate Device - Migwang Comfort 38) | Neo Cosmo Reported Performance |
|---|---|---|
| Material USAN name | Polymacon | Polymacon |
| Water Content | 38±2% | 38±2% |
| Light Transmittance | >90% | >90% |
| Index of Refraction | 1.43 | 1.428 |
| Oxygen Permeability | 9.77 x 10^-11 (cm²/sec)(ml O2/ml * mm Hg @ 35℃) | 9.77 x 10^-11 (cm²/sec)(ml O2/ml * mm Hq @ 35℃) |
| Manufacturing Method | Lathe-cut (semi molded) | Lathe-cut (semi molded) |
| Sterilization | Steam Validated Autoclave | Steam Validated Autoclave |
| Packaging | Blister Pack & vial | Blister Pack & vial |
| Visibility tint (examples) | Titanium Dioxide; 21CFR 73.3126 etc. | Titanium Dioxide (White) etc. |
| Tint Process | Entrapment | Entrapment |
| Powers | +25.00 ~ -25.00 Diopter | +25.00 ~ -25.00 Diopter |
| Total diameter | 12.8 ~ 14.8 | 13.5 ~ 14.5 |
| Geometrical center thickness | 0.03 ~ 0.30 | 0.03 ~ 0.50 |
| Curvature | 8.0 ~ 9.5 | 8.3 ~ 9.0 |
| Optic zone | 6.0 ~ 12.5 | 6.0 ~ 12.5 |
| Radial edge thickness | 0.03 ~ 0.12 | 0.03 ~ 0.05 |
| Toxicity (Safety) | Non-Toxic | Non-Toxic |
| Tensile Strength (MPa) | 0.427 | 0.425 |
| % Elongation to Break | 128% | 127% |
| Module of Elasticity (MPa) | 0.338 | 0.350 |
| Breaking Force (N) | 0.449 | 0.439 |
Non-Clinical Test Results (Page 6-7):
All listed tests (Tensile Testing, Solution Compatibility, various Physical Properties tests, Ocular Irritation Test, Skin Sensitization Test, Cytotoxicity Tests) reported a result of "Pass". The document does not provide specific numerical acceptance criteria for these tests, only that the device met the requirements.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable based on the provided document. The document explicitly states "The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens was not evaluated with clinical testing" (page 7). The "test sets" mentioned relate to non-clinical bench and biocompatibility testing. For example, the Ocular Irritation Study was performed "in NZW Rabbits" and the Skin Sensitization Study used "Guinea-Pig Maximization Test (GPMT)," but specific animal counts are not provided.
- Data provenance: Not explicitly stated for specific test data, but the manufacturer is Neo Vision Co., Ltd. from Korea (page 3).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies with human participants were conducted where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies with human participants were conducted.
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, as no clinical studies, especially MRMC studies involving human readers and AI assistance, were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (contact lens), not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical and biocompatibility tests, the "ground truth" or standard for acceptance would be established by the relevant ISO standards, FDA guidance documents, or other recognized scientific methods for evaluating material properties and biological safety of medical devices. For instance, the Ocular Irritation and Skin Sensitization tests are performed according to established toxicological protocols (e.g., using specific animal models like NZW Rabbits and Guinea-Pigs) to determine irritation and sensitization potential. The physical property tests (Tensile, Elasticity, etc.) would have engineering standards or predicate device specifications as their reference.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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.