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The VISTAKON 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 eves who may have 1.00 D or less of astigmatism.

The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with nondiseased eyes who may have 0.75 D or less of astigmatism.

The VISTAKON 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 VISTAKON 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.

VISTAKON 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 K991163.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VISTAKON contact lenses:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in the way typically seen for new medical device clearances. This 510(k) submission is for a labeling modification to an already cleared device (K991163), not for a new device or a significant change in its design or performance.

The "acceptance criteria" here are implicitly related to demonstrating that the revised labeling (specifically, the claim about reduced risk of giant papillary conjunctivitis) is supported by existing clinical evidence.

However, based on the information, we can infer the "performance" goal as demonstrating the established safety and efficacy for the original device, as the current submission relies on that prior clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated in this document. The submission references "clinical studies published in the July 1999 CLAO Journal" (Attachment A) as the basis for the labeling modification. The sample size would be found within those external publications, but is not provided here.
• Data Provenance: The document does not specify the country of origin of the data. It refers to "clinical studies published in the July 1999 CLAO Journal," which could be from various locations. The studies are assumed to be prospective given they are clinical studies, likely trials, investigating the impact of wear schedules.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the submission. The "ground truth" for the claims about GPC risk reduction would have been established by the methods described in the referenced clinical studies (e.g., clinical examination, diagnosis by ophthalmologists/optometrists). The number and qualifications of the experts involved in those studies are not detailed in this 510(k).

4. Adjudication Method for the Test Set

This information is not provided. As the submission refers to external clinical studies, the adjudication methods (if any, for outcomes like GPC diagnosis) would be detailed within those publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are typically used to evaluate the impact of AI-assisted diagnostic devices on human reader performance. This submission concerns a contact lens, not a diagnostic AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance evaluation was not done. This is not an AI/algorithm-based device. The "performance" being evaluated is related to the clinical outcomes associated with the wear schedule of the contact lens.

7. The Type of Ground Truth Used

The ground truth used for the claims about the reduction of giant papillary conjunctivitis (GPC) would have been clinical diagnosis by eye care professionals. This would involve direct observation and examination of the patient's eyes for signs of GPC as per established diagnostic criteria. It is a form of "expert consensus" or "clinical diagnosis" based on observable medical conditions.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device that requires a training set. The clinical studies supporting the claims would have involved a patient cohort, but it's not a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI/ML algorithm. For the clinical studies, the "ground truth" for GPC diagnosis would have been established by the clinical assessments and diagnoses of the investigators or study clinicians.

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