The AIRPERM (siflufocon A) Rigid Gas Permeable Spherical, Aspherical, Toric and Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Device Description

THE AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR is an aspheric type multifocal which contains an aspherical (conicoid) curve on either the front or back surface. The lens is manufactured by the same method, i.e., lathing, as that used for the AIRPERM (siflufocon A) RIGID GAS PERMEABLE ASPHERIC CONTACT LENSES FOR DAILY WEAR except that the eccentricity of the lens periphery is made higher in order to impart a multifocal effect into the contact lens. The eccentricity for the aspheric single vision lenses varies from 0 to 0.8 and for the multifocal lenses varies from 0.9 to 1.5. All parameters of the AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR are described and measured in exactly the same way as those for the AIRPERM (siflufocon A) RIGID GAS PERMEABLE ASPHERIC CONTACT LENSES FOR DAILY WEAR. The lenses have the following parameters: Chord Diameter Approximately 6.5 to 11.5 mm, Center Thickness for Low Minus Lens: 0.05 to 0.30 mm, for Plus Lens: 0.10 to 0.70 mm, Base Curve 6.50 to 9.00 mm, Powers -20.00 to +12.00 Diopters, Add Powers +1.00 to + 3.00, Eccentricity 0.1 to 1.5. The physical properties of the lens are: Specific Gravity 1.25, Refractive Index 1.43 (589 nm at 25°), Light Transmittance Clear > 92% (380-780 nm), Tinted >88.0% (380-780 nm), Wetting Angle (CLMA Method) 24.0 ± 2, Water Content <1%, Oxygen Permeability 81 x 10-11Dk at 35°C (cm²/sec) (ml O2 x Hg) Polarographic method of I Fatt, Hardness (Shore) 82. The Airperm (siflufocon A) Multifocal Rigid Gas Permeable Contact Lens is available in the lens material siflufocon A a fluorosilicone acrylate polymer which contains D & C Green #6 as a color additive. The aspheric multifocal functions on the basis of a variation in optical power in the form of increasing plus power from the lens center to the periphery. This serves as a bifocal or multifocal add. The aspheric surface is a member of the conicoid family and is defined by the apical radius and eccentricity, e. The eccentricity value describes the rate of flattening of the posterior aspheric surface or the rate of steepening of the anterior surface. The amount of reading addition is the result of the relationship between the apical radius and the eccentricity value.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving such criteria.

The document describes the:

AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR including its physical properties and parameters.
INDICATIONS (USES) and CONTRAINDICATIONS (REASONS NOT TO USE) for the contact lenses.
PRECAUTIONS related to the lenses.
SELECTION OF PATIENTS for whom these lenses are suitable.
FITTING PROCEDURE OUTLINE detailing steps for pre-fitting examination, initial lens power and diameter selection, and initial base curve selection.
Adjunct Solutions used with the lenses.

Therefore, I cannot extract the requested information regarding acceptance criteria and a corresponding study from this text.

Summary

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8962934, Inc. 4505 Van Nuys Blvd. Sherman Oaks, CA 91403

Image /page/0/Picture/1 description: The image shows the number 21 in bold black font. The number is slightly tilted to the left. There is a black rectangle to the right of the number.

Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 6, 2, 9, 3, and 4. There is also a small number '1' below the number 4.

Mr. Nick Stoyan (Telephone 1-800-626-6839)

SUMMARY

AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR

Chord Diameter	Approximately 6.5 to 11.5 mm
Center Thickness
for Low Minus Lens:	0.05 to 0.30 mm
for Plus Lens:	0.10 to 0.70 mm
Base Curve	6.50 to 9.00 mm
Powers	-20.00 to +12.00 Diopters
Add Powers	+1.00 to + 3.00
Eccentricity	0.1 to 1.5
The physical properties of the lens are:
Specific Gravity	1.25
Refractive Index	1.43 (589 nm at 25°)
Light Transmittance
Clear	> 92% (380-780 nm)
Tinted	>88.0% (380-780 nm)
Wetting Angle (CLMA Method)	24.0 ± 2
Water Content	<1%
Oxygen Permeability	81 x 10-11Dk at 35°C(cm²/sec) (ml O2 x Hg) Polarographic method of I Fatt
Hardness (Shore)	82
The Airperm (siflufocon A) Multifocal Rigid Gas
available in the lens material siflufocon A a fluorosili

Permeable Contact Lens is fluorosilicone acrylate polymer which contains D & C Green #6 as a color additive.

The aspheric multifocal functions on the basis of a variation in optical power in the form of increasing plus power from the lens center to the periphery. This serves as a bifocal or multifocal add.

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The aspheric surface is a member of the conicoid family and is defined by the apical radius and eccentricity, e. The eccentricity value describes the rate of flattening of the posterior aspheric surface or the rate of steepening of the anterior surface. The amount of reading addition is the result of the relationship between the apical radius and the eccentricity value.

INDICATIONS (USES):

CONTRAINDICATIONS (REASONS NOT TO USE)

DO NOT USE the AIRPERM (siflufocon A) Rigid Gas Permeable Spherical, Aspherical, Toric and Multifocal Contact Lens when any of the following conditions exist:

· Acute and subacute inflammations or infection of the anterior chamber of the eye.
Any eye disease , injury, or abnormality that affects the cornea, conjunctiva or evelids.
· Severe insufficiency of lacrimal secretion (dry eyes)
· Corneal hypoesthesia (reduced corneal sensitivity) if not aphakic.
· Any systemic disease which may affect the eye or be exacerbated by wearing contact lenses.
· Allergic reactions of ocular surfaces or adnexa which may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
Allergy to any ingredient, such as mercury or Thimerosal, in a solution which is to be used to care for the AIRPERM (siflufocon A) Rigid Gas Permeable Spherical, Aspherical, Toric and Multifocal Contact Lenses.
· Any active corneal infection (bacterial, fungal or viral).
· If eyes become red or irritated

Airperm (siflyfocon A) rigid gas permeable Spherical. Caution: Aspheric Toric and Multifocal contact lenses are shipped to the practitioner non-sterile. Clean and condition lenses prior to use.

PRECAUTIONS

Clinical studies have demonstrated that contact lenses manufactured from the AIRPERM (siflufocon A) rigid gas permeable Spherical, Aspheric Toric and Multifocal lens materials are safe and effective for their intended use. However, due to the small number of patients enrolled in clinical investigation of lenses, all refractive powers, design configurations, or lens parameters available in the lens material are not evaluated in significant numbers. Consequently, when selecting an appropriate lens design and parameters, the eyecare practitioner should consider all characteristics of the lens that can affect lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter.

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The potential impact of these factors on the patient's ocular health should be carefully weighed against the patient's need for refractive correction; therefore, the continuing ocular health of the patient and lens performance on the eye should be carefully monitored by the prescribing eyecare practitioner.

III. SELECTION OF PATIENTS:

Patients are selected who have a demonstrated need and desire for a refractive correction with rigid gas permeable contact lenses and who do not have any of the contraindications for contact lenses described in the package insert.

IV. FITTING PROCEDURE OUTLINE:

Fitting Criteria:

Conventional rigid lens fitting techniques are used. This guide is only a general recommendation and the specification for an individual patient will depend on the eyecare practitioner's professional judgement.

Prefitting Examination:

A completed refraction and visual health examination should be performed.

A pre-fitting patient history and examination are necessary to:

determine whether a patient is a suitable candidate for daily . wear contact lenses (consider patient hygiene and mental and physical state.
. make ocular measurements for initial contact lens parameter selection
collect and record baseline clinical information to which postfitting examination results can be compared.

Initial Lens Power Selection:

Standard procedures for determining power of rigid gas permeable contact lenses may be used, including compensation for vertex distance.

Initial Diameter Selection:

Usually lens diameters between 8.8 mm to 10.5 mm are used to maximize centering to the cornea and to minimize lens movement. Lens diameters outside this range are occasionally used for some eyes. This guide is only a general recommendation and the specification for an individual patient will depend on the eyecare practitioner's professional judgement.

Determining Lens Diameter:

lf K is: 42.00 and flatter ...... use 9.8 mm diameter 42.25 to 44.0 .................................... use 9.5 mm diameter 44.25 and steeper ..... use 9.2 mm diameter
Lens diameter is primarily a function of the base curve but may be influenced by power (plus lenses require a larger diameter to compensate for

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weight) and anatomical considerations (small palpebral opening, excessively large pupil, etc.)

Initial Base Curve Selection:

The base curve is generally fitted on the flattest keratometric finding (fitting on "K") but may vary according to the corneal astigmatism or other individual requirements. This guide is only a general recommendation and the specification for an individual patient will depend on the eyecare practitioner's professional judgement.

Determining Lens Base Curve:

The following table can be used to empirically determine the initial lens parameters.

Cylinder	9.2	9.5	9.8
0 to .75	BC = .25 steeper	on K	.25 flatter
1.00 to 1.50	BC = .50 steeper	.25 steeper	on K
> 1.50	BC = .75 steeper	.50 steeper	.25 steeper

As can be seen from the above table, the base curve determination is a function of corneal cylinder and lens diameter. This guide is only a general recommendation and the specification for an individual patient will depend on the eyecare practitioner's professional judgement.

Initial Lens Evaluation.

Movement:

Blink induced lens movement should optimally move downward with the lid motion and then upward with the lid motion. During the interblink period the lens should have little or no motion.

Positioning:

The lens should position centrally or slightly superiorally to minimize both lens movement and lid sensation. Diagnostic lenses are essential in fitting patients whose corneal topography has been distorted by previous contact lens wear.

Adjunct Solutions

The Adjunct Solutions which were used with Airperm (siflufocon A) Rigid Gas Permeable Spherical, Aspherical and Toric Contact Lenses are as follows:

Boston Conditioning Solution For Rigid Gas Permeable Contact Lenses, consisting of a sterile, buffered, slightly hypertonic solution of low viscosity containing a cationic cellulose derivative polymer as a wetting agent, with edetate disodium (0.05 %) and chlorhexidine gluconate (0.006 %) as preservatives.
Boston Cleaner For Rigid Gas Permeable Contact Lenses, consisting of a concentrated, homogeneous surfactant solution containing alkyl ether sulfate and silica gel as cleaning agents, titanium dioxide and fragrance.
Boston Advance Rewetting Drops, a sterile, buffered, slightly hypertonic solution consisting of a hydrophilic polyelectrolyte to neutralize surface ionic charges and preserved with polyaminopropyl biguanide (0.0015%) and edetate disodium (0.05 %).

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.