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Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A.

This document discusses the K982988 submission for the Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses. The submission is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence, rather than providing extensive de novo clinical trial data.

Therefore, the typical structure for a detailed acceptance criteria breakdown, including specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies associated with new clinical studies for device performance, does not directly apply in the same manner as it would for a PMA (Premarket Approval) or de novo submission requiring extensive new clinical efficacy and safety data.

Instead, the core of this submission revolves around demonstrating that the "Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are identical to previously marketed Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses of the same material" (as stated in Section D). The key point of the K982988 submission is the modification of labeling and indications for use, not a fundamental change in the device itself or its core performance characteristics.

Here's an analysis based on the provided text, addressing your questions where possible within the context of a 510(k) for labeling changes:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for labeling modifications of an already marketed and substantially equivalent device, the acceptance criteria are not explicitly defined in terms of new performance metrics for the device itself. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and justifying the updated labeling.

However, the previous approvals (PMA P940013 and 510(k) K961299) would have established performance criteria for the device's physical, optical, chemical, biocompatible, and microbiological properties, as well as clinical safety and effectiveness for its original indications. The current submission relies on these prior approvals.

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

The document explicitly states: "There were no changes to the lens material or design; however, the associated labeling and indications were changed." This implies that no new clinical test set was used to prove the device's fundamental performance for this specific 510(k) submission. Instead, the submission relies on the existing data and approvals for the predicate device.

The basis for the new labeling claims (specifically UV protection) is described as "referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6". This indicates that the support for the UV claim comes from existing scientific literature and non-clinical data, rather than a new primary clinical trial. Therefore, specific sample sizes and provenance for a "test set" demonstrating the device's primary clinical performance for this submission are not provided because the device itself hasn't changed.

For the original PMA P940013 and 510(k) K961299, clinical trials would have been conducted with specific sample sizes, and the provenance would likely be multi-center clinical studies, typically prospective. However, these details are not provided in this excerpt.

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

Not applicable for this 510(k) submission as no new clinical test set requiring expert adjudication for ground truth was conducted for the device's core performance. The "experts" involved are likely the regulatory reviewers at the FDA and potentially the internal scientific/medical team at Wesley Jessen, who evaluated the referenced literature for the UV claims.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set requiring adjudication was conducted for this 510(k).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and an AI system is evaluated for its assistance. A contact lens is a therapeutic/corrective device, not an interpretative one in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. There is no "algorithm" or AI component to this contact lens.

7. Type of Ground Truth Used:

For the original device approvals (PMA P940013 and 510(k) K961299), the ground truth for clinical safety and effectiveness would have been based on:

• Clinical outcomes data: Measured visual acuity, comfort, adverse event rates, biomicroscopic findings, etc., observed in human subjects.
• Physical/Chemical/Optical standards: Compliance with established laboratory tests for lens properties.

For the new UV claim in this 510(k) K982988, the "ground truth" for the claim's validity is derived from:

• Referenced literature: Epidemiological studies, non-clinical research reports, studies on the nature of UV energy. This implies a scientific consensus on the effects of UV radiation and the ability of certain materials to block it, rather than new primary data from this specific device.

8. Sample Size for the Training Set:

Not applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical product, not an AI.

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

Not applicable.

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Precision UVM (vasurfilcon A) Hydrophilic contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic and may have 2.00 diopters (D) or less of corneal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear as recommended by the eye care practitioner.

Precision UV™ (vasurfilcon A) soft (hydrophilic) contact lenses are available as clear and locator unted spherical lenses in the power range from -10.00 to +6.00 diopters, center thicknesses from 0.10 - 0.26 mm (minus lenses) and 0.18 - 0.37 mm (plus lenses) with base curves of 8.4 and 8.7 mm and a diameter of 14.4 mm. The lens material, vasurfilcon A, is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methyl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilcon A.

The provided text describes a medical device submission (Premarket Notification 510(k) K961299) for tinted contact lenses. The core of the submission is to demonstrate that a change in tinting process and dye for an already approved contact lens (Precision UV™ (vasurfilcon A)) does not negatively impact its safety and effectiveness.

Therefore, the "acceptance criteria" and "device performance" in this context refer to the physical and functional properties of the tinted lens being "substantially equivalent" to the untinted, previously approved lens or lenses tinted with an older process, based on non-clinical laboratory studies. There were no clinical studies conducted or required for this 510(k) submission.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical acceptance limits are provided in the text for characteristics like "physical properties" or "stability," the "acceptance criteria" are implied to be "meeting all product specifications" and demonstrating "no significant differences" compared to the approved clear lenses.

Regarding the remaining questions, it's critical to note that this document is for a 510(k) submission where no clinical studies were deemed necessary or performed. Therefore, many of the questions related to clinical study design, test sets, experts, and ground truth in a clinical context are not applicable.

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

• Sample Size for Test Set: Not specified. The studies were non-clinical laboratory studies. The text only states that "physical properties were measured" and "data has been included."
• Data Provenance: Not explicitly stated, however, as non-clinical laboratory studies performed by the manufacturer, it would be considered internal data, likely from the United States (where Pilkington Barnes Hind is located). The studies were prospective in the sense that they were conducted to support this specific 510(k) submission regarding the new tinting process.

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

• Not Applicable. No ground truth in a clinical sense was established for a test set, as no clinical studies were performed. The "ground truth" here is the adherence to material specifications and stability as measured by laboratory equipment and standard practices.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human adjudication process described for the non-clinical laboratory tests. Results would be "adjudicated" by comparing measurements against predefined specifications and previously approved lens data.

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

• Not Applicable. This is not an AI/diagnostic device. No MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical contact lens; there is no algorithm or standalone performance in the sense of a medical diagnostic device.

7. The Type of Ground Truth Used

• Laboratory Specifications/Measurements: The "ground truth" for the non-clinical studies was the comparison of the physical properties (e.g., water content, optical characteristics, mechanical integrity) and stability of the newly tinted lenses against:
  • The approved specifications for the vasurfilcon A (74%) material.
  • Direct comparison to clear, untinted lenses manufactured using current approved procedures.
• Regulatory Precedent: For safety and efficacy, the ground truth was also established by the prior approval of D&C Green No. 6 dye in other contact lenses (specifically Fluorocon 60 under PMA P890020 and its Supplement 1), and compliance with FDA color additive regulations (21 CFR § 74.3206).

8. The Sample Size for the Training Set

• Not Applicable. Since this is not an AI/machine learning device, there is no "training set" in that context. The "training data" could loosely be considered the accumulated historical data and knowledge about the vasurfilcon A material and general contact lens manufacturing processes that define its known behavior and specifications.

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

• Not Applicable. See point 8.

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