The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.

Device Description

The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are available in violet color. The violet tinted lenses contain D & C Violet # 2 and D & C Red #17. The lenses have the following dimensions and characteristics: Material: Paflufocon E, Indication: Daily wear, Water content: < 1%, Dk (35)°: 67*, Light transmittance Violet****: 92%, Wetting Angle***: 16, Hardness: 81.7, refractive index: 1.454, Specific gravity: 1.10, color: violet. Lens Parameters: Chord Diameter: 7.0 to 10.5 mm, Center Thickness: 0.05 to 0.70 mm, Base Curve: 6.50 to 9.00 mm, Powers: 20.00 to +12.00 Diopters, Bifocal Add Powers: +0.25to +4.00 Diopters, Concentric Bifocal Add Diameter: Not Found, Monocentric Bifocal Add Diameter: Not Found, Monocentric Bifocal Prism: 1.0 to 2.5 Diopters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the PVS BASICS™ (paflufocon E) rigid gas permeable contact lenses, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a clinical trial that established the PVS BASICS™ (paflufocon E) material as safe and effective against a predicate device (paflufocon A / FluoroPerm 92™). Specific numerical acceptance criteria are not explicitly stated as pass/fail thresholds in the provided text. Instead, the study's goal was to demonstrate "equivalence" between the new material and the predicate device for several clinical variables.

The tables below summarize the findings related to safety and symptoms, which implicitly serve as the performance data to demonstrate equivalence, meaning the PVS BASICS™ performed comparably to the established predicate.

Assumed Acceptance Criteria (based on predicate equivalence and safety profile):

No statistically significant difference in Visual Acuity compared to predicate.
No statistically significant difference in Comfort compared to predicate.
No statistically significant difference in Lens-Eye Relationship compared to predicate.
No statistically significant difference in Movement compared to predicate.
No statistically significant difference in Slit Lamp Findings compared to predicate.
No statistically significant difference in Functional Wetting compared to predicate.
Low incidence of adverse events, similar to or better than the predicate.
No serious ocular complications (corneal ulcers, iritis).
Low incidence of staining, edema, injection, or neovascularization exceeding Grade 2.
Patient reported symptoms and complaints comparable to the predicate.

Reported Device Performance (PVS BASICS™ (paflufocon E)) vs. Predicate (Paflufocon A):

Parameter	PVS BASICS™ (paflufocon E) Performance	Predicate (Paflufocon A) Performance	Implicit Finding (Equivalence)
Safety
Discontinued Eyes	2 eyes (out of 70)	0 eyes (out of 22)	Comparable (low incidence)
Average Wearing Time	13.58 (no unit provided, likely hours)	14.09 (no unit provided)	Comparable
All Adverse Reactions	0	0	Equivalent (no adverse reactions)
All Corneal Ulcers	0	0	Equivalent (no ulcers)
All Iritis	0	0	Equivalent (no iritis)
Staining Reports > Grade 2	0	0	Equivalent
Edema Reports > Grade 2	0	0	Equivalent
Injection Reports > Grade 2	0	0	Equivalent
Neovascularization Reports > Grade 2	0	0	Equivalent
Symptoms/Complaints (Final Visit)
None	66.2%	63.6%	Comparable
Discomfort	11.8%	27.3%	PVS BASICS™ lower
Itching/Burning	2.9%	18.2%	PVS BASICS™ lower
Variable Vision	7.4%	18.2%	PVS BASICS™ lower
Blurred Vision	2.9%	36.4%	PVS BASICS™ lower
Lens Needs Cleaning	5.9%	9.1%	PVS BASICS™ lower
Dryness	8.8%	27.3%	PVS BASICS™ lower
Total Positive Reports	29 (Number of positive reports, not %)	24 (Number of positive reports, not %)	Individual symptoms lower for PVS

Study Details

Sample Size used for the test set and the data provenance:
- Test Set (Clinical Study):
  - PVS BASICS™ (paflufocon E) ("Trial Eyes"): 70 eyes enrolled, 68 completed.
  - Predicate (Paflufocon A / FluoroPerm 92™) ("Control Eyes"): 22 eyes enrolled and completed.
  - Data Provenance: The document does not explicitly state the country of origin, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or under U.S. regulatory standards. The study appears to be prospective, described as a "randomized double-masked controlled trial."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The term "ground truth" as typically used in AI/Machine Learning doesn't directly apply here, as this is a clinical trial involving human subjects and direct observation.
- The "ground truth" or clinical data collection was based on direct patient experience and examination by "eye care practitioners" or clinical investigators. The document doesn't specify the number or qualifications of these practitioners.
Adjudication method for the test set:
- The study is described as a "randomized double-masked controlled trial." This means:
  - Randomized: Subjects were randomly assigned to either the test or control lens group.
  - Double-masked: Neither the patients nor the clinical investigators (those examining the patients and collecting data) knew which lens material the patient was wearing. This masking serves to minimize bias in observations and patient-reported outcomes.
  - The process for resolving discrepancies in clinical findings (if any) or adverse event reporting is not explicitly detailed as an "adjudication method" in the provided text.
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:
- No. This was a clinical trial comparing a new contact lens material to a predicate device in humans, not an AI or imaging-based diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance is not applicable here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a contact lens, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study, the "ground truth" (or primary outcome measures) used a combination of:
  - Patient-reported outcomes: Comfort, symptoms, and complaints (e.g., discomfort, dryness, blurred vision).
  - Clinical observations/measurements: Visual Acuity, Lens-Eye Relationship, Movement, Slit lamp Findings, Functional Wetting, and detailed adverse event reporting (staining, edema, injection, neovascularization, corneal ulcers, iritis).
- For biocompatibility, the ground truth was based on established ISO guidelines for ocular irritation (rabbit model), in vitro cytotoxicity (L-929 mouse fibroblast cells), and guinea pig maximization test for sensitization.
The sample size for the training set:
- This is a clinical trial for a physical device, not an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The "training" for the device's development would involve material science, manufacturing, and preclinical testing.
How the ground truth for the training set was established:
- As there is no AI/ML training set, this question is not applicable. The development relied on established scientific principles, pre-clinical testing (biocompatibility and irritation studies mentioned), and comparative analysis against the predicate device.

Summary

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4/21/99

K 9 8 4 4 3 6

APPENDIX H 510(k) Summary

Company Name: Paragon Vision Sciences Submitter. Address: 945 East Impala Ave. Phone: 602-892-7602 Fax: 602-892-3226 Registration: Owner Operator # 9024618

Manufacturer:

Company Name: Paragon Vision Sciences Address: 945 East Impala Ave. Mesa AZ 85204 Phone: 602-892-7602 Fax: 602-892-3226: Registration. Site Registration #2020433

Official Correspondent: William E. Meyers, Ph.D. % Paragon Vision Sciences Address: 945 East Impala Ave. Mesa AZ 85204 Phone: 602-507-7606 Fax: 602-892-3226 Reason for 510(k) Submission: Material change

Date of submission 12/10/98

Device Identification:

Trade Name: PVS BASICS ™ Common Name: contact lens Classification Name: rigid gas permeable contact lens for daily wear Reference: 21 CFR 886.5916;rigid gas permeable contact lens, Class II- daily wear

Indications For Use:

The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas perical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.

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The lenses have the following dimensions and characteristics:

Parameters	PVS BASICS TM
Material	Paflufocon E
Indication	Daily wear
Water content	< 1%
Dk (35)°	67*
Light transmittance Violet****	92%
Wetting Angle***	16
Hardness	81.7
refractive index	1.454
Specific gravity	1.10
color	violet

Oxygen Permeability 67 x10-11Dk* at 35'C

** (cm2/sec)(mL 02/mL x mm Hg) Method of Irving Fatt, Ph.D.

*** after soaking in conditioning solution

*** +12 D, 7mm OZ, 7.8 BC, .45mm CT, harmonic mean thickness over 7mm = 0.329 mm.

Lens Parameters:

Chord Diameter	7.0 to 10.5 mm
Center Thickness	0.05 to 0.70 mm
Base Curve	6.50 to 9.00 mm
Powers	20.00 to +12.00 Diopters
	11:0 -- 1 4 1 1 D ------------------------------------------------------------------------------------------------------------------------------------------------------------

Bifocal Add Powers ... +0.25to +4.00 Diopters Concentric Bifocal Add Diameter ................................................................................................................................................................. Monocentric Bifocal Add Diameter ................................................................................................................................................................. Monocentric Bifocal Prism ..................... 1.0 to 2.5 Diopters

The PVS BASICS 714 (paflufocon E) rigid gas permeable contact lenses are available in violet color. The violet tinted lenses contain D & C Violet # 2 and D & C Red #17.

The PVS BASICS 714 parturocon E) Dk 65 contact lens is substantially equivalent to the FluoroPerin 92 Dk 92 Rigid Gas Permeable Contact Lens marketed by Paragon Vision Sciences which is presently approved for daily wear under PMA (P820063). The physical, optical and chemical properties of the PVS BASICS ™ (paffufocon E) contact lens are substantially equivalent to the FluoroPerm 92 (paflufocon A).

In addition to the physicochemical comparison, toxicity and human clinical studies were conducted.

The test article, PVS Basics (AKA patlufocon E), Batch 234880-6, was extracted in 0.9% sodium chloride USP solution (SC) and cottonseed oil, NF (CSO). These extracts were evaluated for ocular irritation base on the International Organization for Standardization 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization.

A 0.2 ml dose of the appropriate test article extract was instilled in the right eye of three test rabbits. Similarly, the corresponding reagent control was instilled into the left eye of each rabbit to serve as the control conditions were evaluated at 1, 24, 48, and 72 hours after the single exposure.

Under the conditions of this study, there was no evidence of irritation in the test eye or any rabbit.

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The SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbit.

An in vitro biocompatibility test, based on the International Organization (ISO 10993-5) guidelines, was conducted on the test article. PVS Basics (AKA patlufocon E). Lot HS401710-8, in order to determine the potential for in vitro cytotoxicity. A single lens was placed on triplicate agarose surfaces directly overlaying confluent monolayers of L-929 mouse fibroblast cells. Similarly, triplicate negative and positive control wells were presared. After incubating at 37°C in 5% or for 24-26 hours, the cell cultures were examined macroscopically for cell decolorization around the test article and controls to determine the zone of cell lysis (if any). The cultures were then examined microscopically (100X) to verify any decolorized zones and to determine cell morphology in proximity to and beneath the test article.

The negative controls and the positive controls performed. Under the conditions of this study, the test article showed no evidence of causing cell lysis or toxicity. The test article was not cytotoxic and passed this ISO study.

A guinea pig maximization test of PVS Basics (AKA paffuroon E), Batch 234880-6, was conducted to evaluate the potential for delaved dermal contact sensitization. This study was conducted based on the international Organization for Standardization 10993; Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization.

The test article was extracted in 0.9% sodium chloride USP (SC) and contonsed oil. NF (CSO). Each extract was intradermally injected and occlusively patched to test guinea pies (per extract) in an attempt to induce sensitization. The vehicle was similarly injected and occlusively patched to five control guinea pigs (per vehicle). Following a recovery period, the test and control animals received a challenge patch of the appopriate test and the reagent control. All sites were scored at 24, 48 and 72 hours after patch removal.

Under the conditions of this study, the SC and CSO test article extracts showed no evidence of causing delayed demall contact sensitization in the guinea pig.

A clinical evaluation of the safety and effectiveness of the paflufocon E (PVS Basic™) polymer lens was reefformed. This randomized double-masked controlled trial evaluated the clinical performance of lenses produced using the new pathutocon E material in comparison to control lenses made with FDA approved prodicate material, paflufoon A (FluoroPerm 92TN).

Decision criteria were established for the equivalence of the materials these variables were: Visual Acuity, Comfort, Lens-Eye Relationship, Movement, Slit lamp Findings, Functional Wetting,

This clinical trial established Patlufocon E as safe and effective when compared to the currently marketed predicate control material, Paflufocon A (FluoroPerm 92™). The tables below summarize the results of the study.

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EYES ENROLLED IN THE STUDY AND DISTRIBUTION AND STATUS

Status		Number of Eyes
		Paflufocon ATOTALS	PVS BasicsTOTALS
Enrolled Dispensed
Completed		22	68
Active
	Dispensing	22	70
	First Follow Up	22	68
	Final Visit	22	68
Total Active		22	68
Discontinued		0	2
Incomplete		0	0
Total Dispensed		22	70
Enrolled Not Dispensed		0	0
Total Enrolled		22	70

SUMMARY OF FINDINGS RELATED TO SAFETY

	Paflufocon ATOTALS	PVS BasicsTOTALS
NUMBER OF EYES	22	68
DISCONTINUED EYES	0	2
AVERAGE WEARING TIME	$14.09$	$13.58$	TMC
ALL ADVERSE REACTIONS	0	0
ALL CORNEAL ULCERS	0	0
ALL IRITIS	0	0
STAINING REPORTS > GRADE 2	0	0
EDEMA REPORTS >GRADE 2	0	0
INJECTION REPORTS >GRADE 2	0	0
NEOVASC. REPORTS >GRADE 2	0	0
VISITS	44	136
MISSED VISITS	0	0

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SUMMARY OF SYMPTOMS PROBLEMS AND COMPLAINTS

Completed Control Eyes

	Initial DispensingVisit		Intermediate Visits
	1		2
Total Eyes at Visit	22		22		22
	Number	Percent	Number	Percent	Number	Percent
None	19	86.4	16	72.7	14	63.6
Discomfort	3	13.6	4	18.2	6	27.3
Excess Tearing *	0	0	0	0	0	0
Photophobia	0	0	0	0	0	0
Halos	0	0	0	0	0	0
Itching/Burning	0	0	1	4.5	4	18.2
Spectacle Blur*	0	0	0	0	0	0
Variable Vision	0	0	0	0	4	18.2
Blurred Vision	2	9.1	3	13.6	8	36.4
Lens Needs Cleaning	2	9.1	3	13.6	2	9.1
Other
Dryness	2	9.1	3	13.6	6	27.3
Total Positive Reports	9		14		24

Completed Trial Eyes

	Initial DispensingVisit		Intermediate Visits
			1		2
Total Eyes at Visit	70		68		68
	Number	Percent	Number	Percent	Number	Percent
None	55	78.6	52	76.5	45	66.2
Discomfort	6	8.6	4	5.9	8	11.8
Excess Tearing	0	0	0	0	0	0
Photophobia	0	0	0	0	0	0
Halos	2	2.9	0	0	2	2.9
Itching/Burning	1	1.4	2	2.9	2	2.9
Spectacle Blur	0	0	0	0	0	0
Variable Vision	0	0	6	8.8	5	7.4
Blurred Vision	4	5.7	4	5.9	2	2.9
Lens Needs Cleaning	0	0	6	8.8	4	5.9
Other	Dryness
Dryness	5	7.1	5	7.4	6	8.8
Total Positive Reports	18		27		29

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1993

William E. Meyers, Ph.D. Vice President, Science & Technology PARAGON VISION SCIENCES 947 East Impala Mesa, AZ 85204

Re: K984436 Trade Name: PVS BASICS ™ (paflufocon E) Rigid Gas Permeable Contact Lenses For Daily Wear (Spherical, Aspheric, Toric and Bifocal) Clear and Violet Tinted (with D&C Violet # 2 and D & C Red # 17) Regulatory Class: II Product Code: 86 HQD Dated: March 2, 1999 Received: March 3, 1999

Dear Dr. Meyers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect

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Page 2 - William E. Meyers, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

510(k) Number (if known):

Device Name: PVS BASICS TM (paflufocon E)Contact Lens

Indications For Use:

The PVS BASICS "M (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over-The Counter Use

(Optional Format 1-2-96)

Erica

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K 984436

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.