(34 days)
The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or nonaphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The ACUVUE BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.
The ACUVUE TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.
The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
ACUVUE UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
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 frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
The device description does not change from that cleared under K962804.
The provided text describes a 510(k) submission for ACUVUE (etafilcon A) soft (hydrophilic) contact lenses. This submission is for a labeling modification to add an additional Indications Statement. It is not an AI/ML device, and therefore, many of the requested criteria regarding AI/ML device performance and studies are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific acceptance criteria or reported device performance for an AI/ML device. Instead, it refers to the existing clearance of the same lens material (etafilcon A) and its associated performance as sufficient due to the nature of the 510(k) being a labeling modification.
| Acceptance Criteria (Not explicitly stated for AI/ML) | Reported Device Performance (Historical for etafilcon A contact lenses) |
|---|---|
| UV Blocking (UVA) | 82% |
| UV Blocking (UVB) | 97% |
| Clinical Safety | Supported by previously submitted data (N18-033/S31 and K962804) |
| Non-Clinical Safety | Supported by previously submitted data (N18-033/S31 and K962804) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable as this is not an AI/ML device requiring a test set for algorithm performance evaluation. The submission relies on existing clinical and non-clinical data for the lens material itself from previous submissions (N18-033/S31 and K962804). The provenance of that historical data is not detailed in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable as this is not an AI/ML device using a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable as this is not an AI/ML device using a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This is not an AI/ML device, so such a study to evaluate human reader improvement with AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done. This is not an AI/ML device.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML device performance (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The demonstration of safety and effectiveness for a contact lens material (etafilcon A) generally relies on:
- Clinical safety and efficacy data: Data from human trials assessing visual acuity, comfort, ocular health, and adverse events.
- Non-clinical data: Laboratory testing for material properties, microbiology, toxicology, chemistry, shelf-life, and leachability.
The submission states that this data was sufficient for the predicate devices and supports the current device due to no changes in material or manufacturing process.
8. The Sample Size for the Training Set
Not applicable as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as this is not an AI/ML device requiring a training set with established ground truth.
Conclusion:
This 510(k) submission is for a labeling modification for an existing contact lens product. The "device" in question is a contact lens, not an AI/ML diagnostic or therapeutic system. Therefore, most of the requested information pertaining to AI/ML device acceptance criteria, studies, and ground truth establishment is not relevant to this specific document. The submission relies on the previously established safety and effectiveness of the etafilcon A material clear in prior 510(k)s and PMAs.
§ 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.