(63 days)
The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic 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 10.00 D of astigmatism or less.
ACUVUE 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 K991134.
The provided 510(k) submission (K994324) for the ACUVUE (etafilcon A) soft contact lenses is a labeling modification submission, not a submission for a new device requiring a comprehensive performance study against acceptance criteria.
The purpose of this 510(k) is to revise the wear schedule in the labeling to include a statement about the reduced risk of giant papillary conjunctivitis (GPC) with frequent replacement.
Therefore, many of the typical elements of a performance study required for novel device clearance are not present or applicable in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present a table of acceptance criteria or new device performance data in the way a new device would. The core claim is a labeling modification supported by existing clinical literature, not new performance metrics for the device itself.
The "acceptance criteria" in this context would be the FDA's acceptance of the scientific literature supporting the labeling change.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for the labeling claim): The submission states that the labeling modification is supported by "clinical studies published in the July 1999 CLAO Journal (see Attachment A)." Attachment A is not provided in the document. Therefore, the sample size and data provenance of these specific studies are not detailed in this 510(k) submission.
- Data Provenance: The document does not specify the country of origin of the data mentioned in the CLAO Journal. It states the studies were "published," implying they are retrospective in terms of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) submission. As the evidence relies on published clinical studies, the details about expert involvement in establishing ground truth would typically be found within those external publications, not in this regulatory submission.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) submission for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, nor would it be relevant for a contact lens labeling modification based on GPC risk. This type of study is more common for diagnostic imaging or AI-assisted diagnostic devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a contact lens; there is no algorithm or human-in-the-loop performance component.
7. The Type of Ground Truth Used
The "ground truth" for the labeling modification regarding reduced GPC risk would be derived from the clinical outcomes data reported in the published studies cited (July 1999 CLAO Journal). This would include observations and diagnoses of GPC in patients using contact lenses with different replacement schedules.
8. The Sample Size for the Training Set
N/A. This device is a contact lens. There is no training set in the context of machine learning or algorithms. The "training data" for general contact lens safety and efficacy would have been the extensive clinical trials conducted for the original device clearance (K991134).
9. How the Ground Truth for the Training Set Was Established
N/A. See point 8. The ground truth for the original ACUVUE lens (K991134) would have been established through standard clinical trial methodologies, including patient examinations, objective measurements, and subjective patient feedback, reviewed and interpreted by qualified clinicians, to demonstrate the lens's safety and effectiveness for its intended use.
§ 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.