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.

Device Description

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.

AI/ML Overview

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.

Summary

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Pilkington Barnes HindSunnyvale, California	vasurfilcon A (74%)Contact Lenses
Premarket Notification 510(k) K961299

OCT 1 1996

Summary of Safety and Effectiveness

Indications for Use:

Device Description:

Precision UVMA (vasurfilcon A) soft (hydrophilic) contact lenses are currently marketed domestically and internationally by Pilkington Barnes Hind under PMA P940013. Previously, they were marketed by Pilkington Barnes Hind under Allergan Medical Optic's PMA P790020.

Alternate Procedures:

The purpose of this premarket 510(k) notification is to request clearance to tint Precision UVM (vasurfilcon A) contact lenses using an alternative, non-reactive, light blue-green locator tint (D&C Green No. 6, C.I. No. 61565) in an in-monomer tinting process. On January 24, 1995, PBH received clearance in Premarket 510(k) Notification K946012 to tint molded Precision UVM (vasurfilcon A) with a light blue locator tint (Vat Blue No. 6, C.I. No. 69825) using a post-lens manufacture tinting process, hereafter referred to as the CTL process. The alternative tinting process will substitute the use of Vat Blue No. 6 dye and the associated CTL process with the use of non-reactive D&C Green No. 6. This alternative tinting process will hereafter be referred to as an in-monomer tint or IMT process. The lens molding manufacturing process will otherwise remain the same as that currently approved. Further, the use of D&C Green No. 6 in tinting Precision UVTM (vasurfilcon A) lenses will be in accordance with color additive listing provisions of 21 Code of Federal Regulations § 74.3206. It should be noted that D&C Green No. 6 has previously been used in tinting contact lenses. Specifically, PBH received approval on December 28, 1990 in Supplement 1 to PMA P890020 for Fluorocon 60 (pafflufocon B) daily wear (clear and tinted) contact lenses. Notably, these tinted lenses contained D&C Green No. 6.

A minor labeling change has occurred as a result of the use of D&C Green No. 6 dye. Revised, proposed labeling has been included in Section VII, of this premarket 510(k) notification. The changes are clearly marked on the Package Insert and include only those changes relative to the locator tint description of the lens. The proprietary trade name of the lens, as well as the indications for use, will remain the same as those already identified and approved.

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Summary of Safety and Effectiveness, continued...

Summary of Non-Clinical Laboratory Studies:

The alternative IMT tinting process, which substitutes the use of Vat Blue No. 6 dye and the associated CTL process with the use of non-reactive D&C Green No. 6 in the IMT process has been shown to be substantially equivalent, as evidenced by results of the Non-Clinical Laboratory Studies. These laboratory tests fully demonstrate that this process does not affect the substantial equivalence, compatibility, stability or physical functional qualities of the vasurfilcon A lens. Specifically, data has been included which supports 8 months of stability (2 months at 45°C) for Precision UV™ lenses manufactured with the proposed IMT process change. Future testing will continue at room temperature and at 45°C in order to demonstrate stability for 5 years at room temperature.

Clinical Studies:

It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the vasurfilcon A (74%) contact lens tinted with the in-monomer tint process using D&C Green No. 6 dye. This determination was based on the following:

. The use of D&C Green No. 6 in tinting Precision UV™ (vasurfilcon A) daily wear hydrophilic soft contact lenses will be in accordance with color additive listing provisions of 21 Code of Federal Regulations § 74.3206.
. The batch acceptance testing and final lens release criteria remain the same. The vasurfilcon A (74%) physical properties were measured and the results were compared to clear, untinted lenses manufactured with the current approved procedures and specifications. Both the clear lenses manufactured by the current approved procedures and the lenses manufactured with current approved procedures and tinted with D&C Green No. 6 dye using the IMT process showed no significant differences and met all product specifications, as demonstrated by the Non-Clinical Laboratory Study results found in Section IV.
. D&C Green No. 6 dye has been previously used in tinting contact lenses. Specifically, PBH received approval on December 28, 1990 in Supplement 1 to PMA P890020 for Fluorocon 60 (paflufocon B) daily wear (clear and tinted) contact lenses. Notably, these tinted lenses contained D&C Green No. 6 dye.
. The approval of Supplement 1 to PMA P890020 substantiates the safe and efficacious use of D&C Green No. 6 dye as a locator tint in Precision UV™ (vasurfilcon A) daily wear hydrophilic soft contact lenses. In light of the established precedent accompanying the approved use of D&C Green No. 6 in tinting contact lenses, as well as the toxicology and clinical data encompassed by Supplement 1 to PMA P890020, additional studies of this nature were not performed.

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Pilkington Barnes Hind Sunnyvale, California

vasurfilcon A (74%) Contact Lenses

Premarket Notification 510(k)

Summary of Non-Clinical Laboratory Studies:

Clinical Studies:

. The use of D&C Green No. 6 in tinting Precision UV™ (vasurfilcon A) daily and extended wear hydrophilic soft contact lenses will be in accordance with color additive listing provisions of 21 Code of Federal Regulations § 74.3206.
. The batch acceptance testing and final lens release criteria remain the same. The vasurfilcon A (74%) physical properties were measured and the results were compared to clear, untinted lenses manufactured with the current approved procedures and specifications. Both the clear lenses manufactured by the current approved procedures and the lenses manufactured with current approved procedures and tinted with D&C Green No. 6 dye using the IMT process showed no significant differences and met all product specifications, as demonstrated by the Non-Clinical Laboratory Study results found in Section IV.
. D&C Green No. 6 dye has been previously used in tinting contact lenses. Specifically, PBH received approval on December 28, 1990 in Supplement 1 to PMA P890020 for Fluorocon 60 (paflufocon B) daily and extended wear (clear and tinted) Rigid Gas Permeable contact lenses. Notably, these tinted lenses contained D&C Green No. 6 dye.
. The approval of Supplement 1 to PMA P890020 also substantiates the safe and efficacious use of D&C Green No. 6 dye as a locator tint in Precision UV™ (vasurfileon A) daily and extended wear hydrophilic soft contact lenses. In light of the established precedent accompanying the approved use of D&C Green No. 6 in tinting contact lenses, as well as the toxicology and clinical data encompassed by Supplement 1 to PMA P890020, additional studies of this nature were not performed.

Regulation Number and Section

§ 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.