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, and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. 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 absorher.

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 lenses may also be supplied clear (no tint).

AI/ML Overview

The provided text describes information for the "BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON XO® (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES". However, it is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way a clinical trial would for a novel medical device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size) are not applicable or not provided in this type of document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail sense against pre-defined thresholds. Instead, it reports the physical/optical properties of the lenses, which are implicitly accepted given their substantial equivalence claim. The reported properties are presented below:

Property	BOSTON ES	BOSTON EO	BOSTON XO
Specific Gravity	1.22	1.23	1.27
Refractive Index	1.443	1.429	1.415
Visible Light Transmittance	> 85%	> 85%	> 92%
Water Content	<1%	<1%	<1%
Wetting Angle	52°	49°	49°
Oxygen Permeability (Dk)***	3618*	8258*	140100*

gas to gas method
polarographic method (ISO/Fatt)
***(x 10⁻¹¹ (cm³ O₂ • cm)/ (cm² • sec • mmHg) @ 35° C}

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission based on substantial equivalence to existing predicate devices, not a clinical trial with a "test set" in the context of AI/software performance. The safety and efficacy were previously demonstrated in earlier 510(k) clearances.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a 510(k) submission.

4. Adjudication method for the test set

Not applicable. This is a 510(k) submission.

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 device, not an AI-based diagnostic tool requiring MRMC studies.

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

Not applicable. This is a contact lens device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document supports the safety and effectiveness of the device by demonstrating its physical/optical properties and clinical indications are substantially equivalent to previously cleared predicate devices. The "ground truth" here is regulatory acceptance based on comparisons to established, safe, and effective devices, as well as adherence to recognized material property standards.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical device, not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. This is a 510(k) submission for a physical device, not an AI algorithm.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The document itself is the "study" in the context of a 510(k). It states:

"The safety and efficacy of BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses was demonstrated in 510(k) Premarket Notifications as follows: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively. The most recent Premarket Notification for all three materials (Boston ES, EO, and XO) was 510(k) K013762, cleared April 3, 2002, for a new indication for keratoconus."
"BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, including an indication for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplastv."

This means the "study" is a historical chain of prior 510(k) clearances and the demonstration that the current devices' physical properties and indications are substantially equivalent to those already cleared. There is no new clinical trial data presented in this specific 510(k) summary (K053124) to validate performance against novel acceptance criteria. Instead, the "acceptance criteria" are effectively met by demonstrating that the device is the same or very similar to already approved predicate devices.

Summary

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JAN 3 0 2006

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND DOSTON 20 - (Smidloodl A), DOSTON EO - (ennutocon 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: Lisa Graney Manager, Global Regulatory Affairs Telephone No .: (585) 338-6612

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 DEVICES

Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufiocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, have been selected as the predicate devices for the BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses.

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 lenses may also be supplied clear (no tint).

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lenses for Daily Wear

Property	BOSTON ES	BOSTON EO	BOSTON XO
Specific Gravity	1.22	1.23	1.27
Refractive Index	1.443	1.429	1.415
Visible Light Transmittance	> 85%	> 85%	> 92%
Water Content	<1%	<1%	<1%
Wetting Angle	52°	49°	49°
Oxygen Permeability (Dk)***	3618*	8258*	140100*

The physical / optical properties of the lenses are:

gas to gas method

**polarographic method (ISO/Fatt) ***(x 101'' (cm³ O₂ • cm)/ (cm² • sec • mmHg) @ 35° C}

5. INDICATIONS FOR USE

6. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE

The safety and efficacy of BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses was demonstrated in 510(k) Premarket Notifications as follows: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively. The most recent Premarket Notification for all three materials (Boston ES, EO, and XO) was 510(k) K013762, cleared April 3, 2002, for a new indication for keratoconus.

BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, including an indication for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplastv.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2006

Bausch and Lomb Incorporated c/o Ms. Lisa Graney Manager, Global Regulatory Affairs 1400 North Goodman St. Rochester, NY 14609

Re: K053124

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: HOD Dated: November 4, 2005 Received: November 15, 2005

Dear Ms. Graney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, True, 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 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 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 comply with 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. Lisa Graney

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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, M.D.

Acting Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo and address of Bausch & Lomb. The address is 1400 North Goodman Street, Rochester, NY 14609. The logo is a stylized version of the company name.

Indications for Use Statement

510(k) Number (if known): K 05 3124

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

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 (mynpia, hyperopia, astigmatism, presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

Prescription Use √ AND/OR Over-The-Counter Use __
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Myna Smith

(Division Sign-Off)

ivision of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K053124

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.