(78 days)
The iO2 Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with nondiseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D.
The ASTERA Multifocal iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or nonaphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D and have near add requirements up to 3.25 D.
The iO2Toric (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non- aphakic persons with non diseased eyes in a spherical power range of +30.00 to -30.00 D and a cylinder power range up to -10.0D.
The ASTERA Multifocal Toric iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non- aphakic patients with non-diseased eyes in a spherical power range of +30.00 to -30.00 D, a cylinder power range up to -10.00 D and an add requirement up to 3.25 D.
iO2 lenses may be disinfected using chemical (not heat) disinfecting systems.
The iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, multifocal, toric, and toric-multifocal designs. Specifically, the iO2 Sphere, iO2 Toric, ASTERA Multifocal iO2, and ASTERA Multifocal Toric iO2 models are hemispheric flexible shells. All iO2 lenses are plasma treated in the dry state prior to initial hydration. The lens material (mangofilcon A) is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A and 49% water by weight. Mangofilcon A is available clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). Mangofilcon A is also available in Blue or Aqua visibility tints to assist with handling. Both colors are available with or without the UV absorber.
This 510(k) summary (K133079) details the substantial equivalence of the Alden Optical Laboratories' iO2 (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear to a predicate device. The information provided outlines non-clinical performance data for the device but does not include any clinical study data involving human subjects or experts to prove the device meets specific acceptance criteria.
Therefore, I cannot populate the requested sections regarding acceptance criteria, reported performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from this document. The submission relies solely on a comparison of physicochemical properties and manufacturing processes to a legally marketed predicate device.
However, based on the provided text, I can infer the acceptance criteria are implicitly aligned with demonstrating physicochemical and safety characteristics equivalent to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (iO2 mangofilcon A) |
|---|---|---|
| Marketing Status | K120756 (Legally Marketed) | Not Yet Cleared (Seeking Clearance) |
| USAN | Mangofilcon A | Mangofilcon A |
| Device Class | II | II |
| FDA Product Code | LPL | LPL |
| Regulation | 21 CFR 886.5925 | 21 CFR 886.5925 |
| Intended Use | Same as subject iO2 | Same as predicate LSH |
| Manufacturing Method | Lathe-cut | Lathe-cut |
| Plasma Treatment? | Yes | Yes |
| Water Content | 49% | 49% |
| Oxygen Transmissibility (Dk) | 49 (ISO/Fatt) | 49 (ISO/Fatt) |
| Refractive Index (Dry) | 1.470 | 1.470 |
| Refractive Index (Hydrated) | 1.413 | 1.413 |
| Specific Gravity (Dry) | 1.112 | 1.112 |
| Specific Gravity (Hydrated) | 1.109 | 1.109 |
| Shore D Hardness | ≥ 83 | ≥ 83 |
| Tensile Strength | 3.07 M Pa | 3.07 M Pa |
| Elongation at Break | 470% | 470% |
| Light Transmittance (Clear) | 96%T | 96%T |
| Light Transmittance (Tinted) | >70%T | >70%T |
Note: The acceptance criteria are implicitly defined by the characteristics of the predicate device, K120756 (LSH mangofilcon A). The "study" proving the device meets these criteria is the non-clinical analysis and testing performed by the manufacturer, which showed identical or equivalent physicochemical properties to the predicate.
The following information is NOT available in the provided document:
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set (i.e., human subjects) was used for safety and effectiveness comparison in this submission. The "test set" here refers to material samples for non-clinical analysis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as expert evaluation of clinical performance is not mentioned. The "ground truth" for the non-clinical tests is based on established scientific measurement methods for material properties.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the non-clinical characterization, the "ground truth" is the scientifically measured physiochemical properties of the material and the finished lenses, compared directly to the predicate device.
- The sample size for the training set: Not applicable, as there is no mention of a training set as would be used for an AI/ML device. For manufacturing, quality control involves testing batches, but this isn't designated as a "training set" in this context.
- 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.