The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Device Description

The BOSTON ES® (enflufocon A) and BOSTON EO® (enflufocon B) are Rigid Gas Permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.

BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.

The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BOSTON ES®, BOSTON EO®, and BOSTON® XO Rigid Gas Permeable Contact Lenses.

It's important to note that this document is a 510(k) summary, which often points to prior submissions and substantial equivalence rather than detailing a new comprehensive clinical study for the specific device being cleared.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to a predicate device (BOSTON® II itafocon A). This means that the new devices are considered safe and effective because they are as safe and effective as a legally marketed device.

The "performance" for these new devices is presented not as a comparison against specific numerical targets, but as their fundamental physical and optical properties, which are then implicitly considered acceptable because they fall within the parameters of what is deemed safe and effective for rigid gas permeable contact lenses, similar to the predicate.

Acceptance Criteria Category (Implicit)	Specific Criteria (from predicate/general RGP lens standards)	Reported Device Performance (BOSTON ES, EO, XO)
Substantial Equivalence to Predicate Device	Safety and efficacy equivalent to BOSTON® II (itafocon A) lens.	Achieved through similarity in materials, indications for use, and general design.
Material Composition	Appropriate for RGP contact lenses, including UV absorber.	BOSTON ES/EO: aliphatic fluoroitaconate siloxanyl methacrylate copolymer with UV absorber. BOSTON XO: siloxanyl fluoromethacrylate copolymer with UV absorber. Color additives conform to 21 CFR Part 74/73.
Physical/Optical Properties	Within acceptable ranges for RGP lenses (specific gravity, refractive index, light transmittance, water content, oxygen permeability).	BOSTON ES: Specific Gravity: 1.22 Refractive Index: 1.443 Light Transmittance: C.I.E. Y value - at least %
Indications for Use	Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and non-aphakic persons with non-diseased eyes; chemical disinfection only.	Matched to predicate device's indications, as stated in the submission.

Notes:

Specific numerical acceptance criteria for each physical/optical property are not explicitly stated in this 510(k) summary, but are implied to be acceptable based on the predicate and general RGP lens standards.
The "at least %" for Light Transmittance in BOSTON ES and EO is an incomplete entry in the original document.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The safety and efficacy of BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas PermeableContact Lenses was demonstrated in 510(k) Premarket Notifications: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively."

This means that the current 510(k) (K013762) is leveraging previous clearances. The specific details of the test sets (sample sizes, prospective/retrospective, country of origin) for those earlier 510(k)s are not provided in this summary document. This 510(k) relies on the fact that those previous submissions adequately demonstrated safety and efficacy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For 510(k) submissions, particularly for devices with a clear predicate, detailed expert adjudication for ground truth (as might be seen in AI/diagnostic device studies) is generally not required unless there's a novel aspect requiring new clinical data. The primary "ground truth" here is the established safety and efficacy of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided in the summary.

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

No MRMC study was done or is mentioned. This type of study is specifically relevant for AI-powered diagnostic devices where human interpretation interacts with AI output. These contact lenses are a medical device, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a contact lens, not an algorithm. Its performance is inherent in its physical and material properties, and its interaction is directly with the human eye, not through an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary "ground truth" for these contact lenses, as presented in this 510(k) summary, is:

Substantial Equivalence to a Predicate Device: The established safety and efficacy of the BOSTON II (itafocon A) Rigid Gas Permeable Contact Lens, which was approved under a Premarket Application (PMA P820065). This implies that the predicate device underwent comprehensive clinical trials and demonstrated safety and efficacy through clinical outcomes data, which then serves as the benchmark.
Physical and Optical Property Characterization: The physical properties of the new lenses (e.g., oxygen permeability, refractive index) are measured and implicitly compared against accepted standards for RGP lenses, which are themselves derived from years of clinical experience and outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI algorithm.

Summary

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APR 0 3 2002

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON® XO (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES

1. SUBMITTER INFORMATION

Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609

Contact Person:	Debra Ketchum
	Manager, Regulatory Affairs
Telephone No.:	(585) 338-8638

2. DEVICE NAME

Classification Name: rigid gas permeable (hydrophobic) contact lens

Proprietary Name: BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses

3. PREDICATE DEVICE

The BOSTON® II (itafocon A) Rigid Gas Permeable Contact Lens approved in Premarket Application, P820065, on November 17, 1983, has been selected as the predicate device for the BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses.

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DESCRIPTION OF DEVICE 4.

BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.

The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).

Property	BOSTON ES	BOSTON EO	BOSTON XO
Specific Gravity	1.22	1.23	1.27
Refractive Index	1.443	1.429	1.415
Light Transmittance	C.I.E. Y value	C.I.E. Y value	C.I.E. Y value
	- at least %	- at least %	- at least 92%
Water Content	<1%	<1%	<1%
Oxygen Permeability (Dk)	36*	82*	140*
	18**	58**	100**

The physical / optical properties of the lens are:

*gas to gas

*ISO/Fatt

5. INDICATIONS FOR USE

The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and notaphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE 6.

The safety and efficacy of BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas PermeableContact Lenses was demonstrated in 510(k) Premarket Notifications: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively.

BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to BOSTON II (itafocon A) Rigid Gas Permeable Contact Lenses approved in Premarket Application, P820065, on November 17, 1983 including an indication for keratoconus.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra Ketchum Bausch and Lomb Inc. 1400 N. Goodman St. Rochester, NY 14609

APR 0 3 2002

Re: K013762

Trade/Device Name: Boston ES® (enflufocon A), Boston EO® (enflufocon B) and Boston® XO (hexafocon A) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: February 28, 2002 Received: March 1, 2002

Dear Ms. Ketchum:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it 11 70ar device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Debra Ketchum

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

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

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510(K) PREMARKET NOTIFICATION 510(K) PREMARKET NOTIFICATION
BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), and BOSTON® XO (hexafocon A) RGP Contact Lens

Bausch & Lomb 1400 North Goodman Street . Rochester, NY 14609

Indications for Use Statement

K013762 510(k) Number (if known):

Device Name:

BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON® XO (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES

Indications for Use:

(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

Mira Smith
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number: K 013762

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.