(180 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to current approved lenses. | Demonstrated by non-clinical laboratory studies. Process does not affect substantial equivalence, compatibility, stability, or physical functional qualities. |
| Compatibility with the eye (safety and efficacy). | Implicitly met by previously approved lens material and prior approval of D&C Green No. 6 dye in other contact lens products (PMA P890020 for Fluorocon 60 and Supplement 1 to PMA P890020). Clinical studies were not deemed necessary due to established prior use and regulatory compliance (21 CFR § 74.3206). |
| Stability for the proposed shelf life. | Data supports 8 months of stability (2 months at 45°C) for the IMT process lenses. Future testing will continue to demonstrate stability for 5 years at room temperature. |
| Physical properties meeting "all product specifications." | Vasurfilcon A (74%) physical properties were measured for IMT tinted lenses and compared to clear, untinted lenses manufactured with current approved procedures. Both sets of lenses showed no significant differences and met all product specifications. This includes batch acceptance testing and final lens release criteria remaining the same. |
| Compliance with color additive listings. | The use of D&C Green No. 6 in tinting is in accordance with color additive listing provisions of 21 Code of Federal Regulations § 74.3206. |
| No interference with indications for use (correction of acuity). | Not explicitly stated as a separate test, but implied by demonstrating substantial equivalence in physical properties and the fact that the tint is a "locator tint" and not intended to affect optical properties for vision correction (beyond what is already approved for the clear lens). The proprietary trade name and indications for use "will remain the same." |
| Acceptable manufacturing process. | The alternative IMT tinting process (using non-reactive D&C Green No. 6) has been shown to be substantially equivalent to the previously approved CTL process (using Vat Blue No. 6). The lens molding manufacturing process will otherwise remain the same as that currently approved. |
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.
§ 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.