(272 days)
I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 5.00 Diopters.
Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily I-55 Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not aphakic persons with non-diseased eves that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.
I-55 Single Vision, I-55 Toric and I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The I-55 Single Vision Contact Lens is available in a single vision lens design, the I-55 Toric Contact Lens is available in a back surface design, and the I-55 Multifocal Contact Lens is available in a concentric lens design. The lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contain 55% water by weight. I-55, I-55 Toric and I-55 Multifocal initiation The Tenb Contain of hilic) Contact Lenses for Daily Wear are visibility tinted using Pigment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR § 74.3045.
The provided text describes soft contact lenses and a comparison to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a data-driven approach, which would be typical for an AI/ML medical device.
Here's an analysis based on the provided text, specifically noting what is missing regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table between the new device (I-55 Single Vision, I-55 Toric, and I-55 Multifocal) and a predicate device (Definition AC). This comparison acts as the primary "performance" metric, aiming to show substantial equivalence rather than meeting specific statistical acceptance criteria for a new, AI-driven functionality.
| Characteristic | Acceptance Criteria (Predicate Device Value) | Reported Device Performance (I-55 Lenses) |
|---|---|---|
| Material | methafilcon A | methafilcon A |
| Material Classification | Hydrophilic Lens Group 1 | Hydrophilic Lens Group 1 |
| Indication for Use | myopia, hyperopia, astigmatism, presbyopia | myopia, hyperopia, astigmatism, presbyopia |
| Water Content | 55% | 55% |
| Visible Light Transmittance | 98% | 99% |
| Dk (35° C) | $18.86 \times 10^{-11}$ | $19.01 \times 10^{-11}$ |
| Powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| Color | blue visibility | blue visibility |
| Refractive Index | 1.416 | 1.415 |
| Specific Gravity | 1.030 | 1.039 |
| Method of Manufacture | Molded | Molded |
Missing from the document relevant to "acceptance criteria" for an AI/ML device:
- Specific quantitative performance metrics like sensitivity, specificity, accuracy, AUC, etc., and their corresponding pre-defined acceptance thresholds.
- A statistical study demonstrating that the device meets these thresholds. The document instead relies on demonstrating "substantial equivalence" to a predicate device for its physical and chemical properties and indications for use.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/Not mentioned. The document describes pre-clinical tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, and Physico-chemical testing) and shelf-life testing. These are not what would typically be considered "test sets" for evaluating AI/ML performance on clinical data.
- Data Provenance: Not applicable/Not mentioned for any clinical data evaluation. The pre-clinical tests were likely conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" in this context relates to the established safety of the lens material and its physicochemical properties, which are determined by standard laboratory tests and material science, not by expert review of clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As no clinical test set requiring expert adjudication is described, no adjudication method is relevant.
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:
- No MRMC study was done. This device is a contact lens, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the safety and equivalence claim is based on:
- Results of standard pre-clinical tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity).
- Conformance to standards for residue levels.
- Physicochemical testing results.
- Shelf-life stability data.
These are objective measurements and established scientific protocols rather than expert consensus on clinical cases or pathology.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm being trained, so no training set exists.
9. How the ground truth for the training set was established:
- Not applicable.
In summary:
This 510(k) summary is for a physical medical device (contact lenses) and demonstrates substantial equivalence to a predicate device based on material properties, manufacturing method, and safety testing (toxicology, irritation). It does not involve any AI/ML components or clinical performance studies with acceptance criteria, ground truth establishment by experts, or reader studies as would be expected for an AI/ML device.
§ 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.