(70 days)
The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with nondiseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only
The BOSTON ES MULTIVISION (enflufocon A) is an aspheric multifocal rigid gas permeable, fluoro silicone acrylate contact lens for daily wear. The BOSTON ES MULTIVISION (enflufocon A) contact lens provides distance and near vision through the use of its back surface design. The central portion of the lens provides the distance vision; the mid-peripheral portion provides the near vision and the far peripheral portion provides the fitting performance of the lens. The aspheric design is a series of ever increasing radius curves from the center of the lens to the periphery which provides the ' add' power for central ellipse for distance vision, a hyperbolic curve in the midperiphery for the near vision, and a fillet and steeper hyperbolic design in the periphery for the fitting design.
The provided document describes a 510(k) summary for the BOSTON® ESTM MULTIVISION (enflufocon A) Contact Lens. It references a clinical study conducted for a previous 510(k) for the same material (K943177) to support the current premarket notification. Therefore, the acceptance criteria and study details are derived from this referenced study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds. However, it implicitly uses visual acuity as a key performance indicator to demonstrate effectiveness.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Acuity | Satisfactory visual acuity (e.g., 20/30 or better) | 95.1% of acuities reported for completed eyes at 20/30 or better |
2. Sample size used for the test set and the data provenance
- Sample Size: 216 patients (432 eyes)
- Data Provenance: Not explicitly stated, but implies multi-site clinical study within the United States given it's a 510(k) submission referencing US regulatory context. It is a retrospective use of data for this specific submission, but the original study was a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts establishing ground truth. The "ground truth" here is the clinical endpoint of visual acuity as measured by standard optometric methods (e.g., Snellen chart readings).
4. Adjudication method for the test set
The document does not describe any specific adjudication method. Standard clinical trials for contact lenses would typically involve trained clinicians (e.g., optometrists, ophthalmologists) following a defined protocol to assess visual acuity.
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 a contact lens approval, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a contact lens approval, not an AI-powered diagnostic device.
7. The type of ground truth used
The ground truth used was clinical outcomes data, specifically:
- Visual acuity measurements (e.g., Snellen chart readings).
- Patient reports of wearing time.
- Discontinuation rates and reasons (absence of adverse reactions).
8. The sample size for the training set
The concept of a "training set" is not applicable as this is not an AI/machine learning device. The 216 patients (432 eyes) represent the clinical studycohort used to evaluate the device performance.
9. How the ground truth for the training set was established
Not applicable as this is not an AI/machine learning device. The clinical study established the performance data through direct patient evaluation.
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POLYMER TECHNOLOGY
1400 N. GOODMAN STREET · ROCHESTER, NEW YORK 14692
Image /page/0/Picture/2 description: The image shows a black and white abstract design. The design features a large, curved shape that takes up most of the image. A smaller, rectangular shape is positioned near the bottom right of the curved shape, creating a contrast between the two forms. The overall composition is simple yet striking, with the stark contrast between black and white enhancing the visual impact.
MAY - 6 1997
510(x) SUMMARY
SUBMITTED BY:
Polymer Technology a division of Wilmington Partners, L.P. ﻴﺘ 1400 North Goodman Street
Rochester, NY 14692
TRADE/PROPRIETARY NAME
BOSTON® ESTM MULTIVISION (enflufocon A) Contact Lens
CLASSIFICATION NAME:
Contact Lens - rigid gas permeable
COMMON/USUAL NAME:
Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material
PREMARKET NOTIFICATION NUMBER:
CONTACT PERSON:
Contact Person:
Telephone No .: Fax No .: E-mail Address:
Douglas J. Fortunato Director, Regulatory Affairs (716) 338-5477 (716) 338-0702 dfortunato@bausch.com
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POLYMER TECHNOLOGY 1400 N. GOODMAN STREET . ROCHESTER, NEW YORK 14692
で
Image /page/1/Picture/2 description: The image is a black and white graphic. The majority of the image is a solid black shape that resembles a semi-circle or a rounded shape. In the lower center of the image, there is a white rectangular shape that extends upwards into the black area. The overall composition is simple, with a strong contrast between the black and white elements.
イヤービュームファイ
INDICATIONS FOR USE:
The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with nondiseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only
STATEMENT OF EQUIVALENCE:
The BOSTON ES MULTIVISION (enflufocon A) contact lens is made of the same material as BOSTON ES (enflufocon A), a daily wear fluoro silicone acrylate contact lens material as cleared under 510(k) Premarket Notification No. K943177. The United States Adopted Name (USAN) enflufocon A is unchanged. Substantial equivalence is also determined by the design equivalence to the BAUSCH & LOMB Occasions " (polymacon) Visibility Tinted Multifocal Contact Lens as approved under PMA N16-895; and the BOSTON ENVISION aspheric single vision, back surface design as cleared under 510(k) Premarket Notification No. K942365. Equivalence in design is determined by both lens designs being aspheric, in which a series of different radius curves from center to edge of the lens are used to describe the back surface of the lens, and create the 'add' effect for the multifocal power.
DEVICE DESCRIPTION:
The BOSTON ES MULTIVISION (enflufocon A) is an aspheric multifocal rigid gas permeable, fluoro silicone acrylate contact lens for daily wear. The BOSTON ES MULTIVISION (enflufocon A) contact lens provides distance and near vision through the use of its back surface design. The central portion of the lens provides the distance vision; the mid-peripheral portion provides the near vision and the far peripheral portion provides the fitting performance of the lens. The aspheric design is a series of ever increasing radius curves from the center of the lens to the periphery which provides the ' add' power for
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OLYMER TECHNOLOGY 1400 N. GOODMAN STREET · ROCHESTER, NEW YORK 14692
Image /page/2/Picture/1 description: The image shows a black and white abstract shape. The shape is mostly black, with a small white portion at the bottom. The black portion is curved on the top and left sides, and has a small rectangular cutout on the right side.
central ellipse for distance vision, a hyperbolic curve in the midperiphery for the near vision, and a fillet and steeper hyperbolic design in the periphery for the fitting design.
The lens parameters available are:
| Chord Diameter: | 7.0 to 11.5 mm (to prescription) |
|---|---|
| Center Thickness: | 0.07 to 0.65 mm (varies with power anddiameter |
| Base Curve: | 5.0 to 9.0 mm in 0.01 mm steps |
| Power: | +20.00 to -20.00 in 0.12 D increments fordistance+1.50 D nominal add |
| Optical Zone: | To prescription |
All physical, optical and chemical properties are equivalent to the BOSTON ES (enflufocon A) material as cleared in 510(k) K943177. See attached summary. The physical properties of the subject contact lens are as follows:
| Oxygen Permeability: | 31 x 10-11 (cm³O₂ • cm)/(cm² • sec • mmHg)@ 35°C (standard deviation=3) |
|---|---|
| Wetting Angle: | 52° ±3 |
| Water Content: | <1% (Gravimetric Method) |
| Index of Refraction: | 1.443±0.003 (Abbe Refractometer) |
| Light Transmittance: | 84.6% at average thickness of 0.15 mm(-3.00) |
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OLYMER TECHNOLOGY
Image /page/3/Picture/2 description: The image shows a black and white abstract design. The design features a large, curved black shape that dominates the left side of the image. A white, T-shaped figure is positioned in the lower right corner, partially overlapping the black shape. The contrast between the black and white elements creates a bold and graphic composition.
CLINICAL:
The clinical study used to support this premarket notification is the clinical study conducted on the same material in support of the spherical indication for myopia and hyperopia as reported in K943177 approved on August 25, 1994.
The study involved eleven investigational sites and 216 patients (432 ー eves) for a period of three months. 217 subjects entered the study and 185 subjects completed the study. Thirty-one subjects were discontinued from the study. No subjects were discontinued from the study for adverse reactions. Subjects recruited into the study ranged in age from 18 to 67, with a mean age of 39.
Completed and discontinued patients reported consistently good visual acuities with 95.1% of acuities reported for completed eyes at 20/30 or better. During the study the average lens wearing time for completed eyes was between 13.7 and 14.2 hours per day.
CONCLUSION:
The results from all non-clinical and clinical studies demonstrate that the BOSTON ES rigid gas permeable contact lens is safe, effective. and performs as well as or better than the predicate device.
§ 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.