BOSTON XO (hexafocon A) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and nresbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

Device Description

The BOSTON XO Contact Lens Material, hexafocon A, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer. The color additives conform to 21 CFR part 74.3206. The hexafocon A material has an oxygen permeability, DK of 100, a specific gravity of 1.26, and the lens visible light transmittance of at least 70%. The hexafocon A name has been adopted by the United States Adopted Names Council (USAN).

AI/ML Overview

The provided text describes the BOSTON XO (hexafocon A) Contact Lens Material, and its submission for 510(k) clearance, asserting substantial equivalence to the predicate device, BOSTON ES (enflufocon A). The document focuses on preclinical and clinical studies conducted to support this claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the clinical study in the format of a target value to be met. Instead, it concludes equivalence to the predicate device. The preclinical tests had requirements that were met.

Test Category	Acceptance Criteria/Requirement	Reported Device Performance
Preclinical Testing
In-Vitro Cytotoxicity	Meets requirements of USP XXII for Agar Diffusion Test	"The test article meets the requirements of the Agar Diffusion Test."
Acute Ocular Irritation	No ocular irritation produced	"produced no ocular irritation."
Systemic Injection	Meets requirements of Systemic Injection Test; considered non-toxic	"The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic."
Shelf Life	Not required for clearance (due to <1% water content and dry shipping)	"shelf-life studies are not required for clearance of this material."
Solution Compatibility	No significant changes to lens parameters after 30 cycles of cleaning and conditioning	"There were no significant changes to lens parameters after 30 complete cycles."
Clinical Testing
Overall Safety & Efficacy	Equivalent to predicate device (Boston ES)	"The sponsor concludes that BOSTON XO (hexafocon A) contact lens material is equivalent in safety and efficacy to the predicate device, Boston ES (enflufocon A)."

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

Sample Size (Clinical Study):
- Enrolled: 128 eyes (64 patients)
- Completed Study: 102 eyes (51 patients)
Data Provenance: The document does not explicitly state the country of origin. It does state that "3 Investigators" were involved, which often implies a multi-site study, but specific locations are not provided. The study was prospective, as patients were "entered into the study" and followed.

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

The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for the clinical study in the way one might assess an AI diagnostic device. Instead, the "safety and efficacy measures" were assessed by the clinical investigators. The document mentions "3 Investigators" who entered patients into the study. Their specific qualifications are not detailed beyond "Investigators."

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical study's safety and efficacy measures. The results are presented as conclusions from the study, without mentioning independent adjudication or consensus review of specific findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the evaluation of a contact lens material, not an AI-assisted diagnostic system. Therefore, assessing how much human readers improve with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study

No, a standalone performance study in the context of an "algorithm only" or AI system was not conducted. This document describes the evaluation of a contact lens material, which does not involve an algorithm or AI.

7. Type of Ground Truth Used

For the preclinical tests, the "ground truth" was based on established standard testing methodologies (e.g., USP XXII, Systemic Injection Test requirements) and observable physical changes.

For the clinical study, the "ground truth" for safety and efficacy was established through clinical observations and measurements by the investigators. These included:

Adverse Events (self-reported and observed)
Positive Slit Lamp Findings
Symptoms/Complaints (patient-reported)
Keratometry Changes (objective measurement)
Refractive Changes (objective measurement)
Lens Visual Acuity (objective measurement)
Lens VA Line Changes (objective measurement)
Lens Deposits (objective observation/grading)
Lens Wettability (objective observation/grading)

This constitutes a form of expert assessment and objective measurement in a clinical setting.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a medical device (contact lens material) and its evaluation methods do not involve AI training. Therefore, this information is not applicable.

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

As there is no mention of a training set for an AI system, this question is not applicable.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BOSTON XO

1. SUBMITTER INFORMATION:

Polymer Technology Global Vision Care 1400 N. Goodman Street Rochester, New York 14603-0450

2. CONTACT PERSON:

	Manager, Regulatory Affairs
Address:	1400 North Goodman Street
	P.O. Box 450
	Rochester, New York 14603-0450
Telephone No.:	(716) 338-8638
Fax No.:	(716) 338-0702
E-mail Address:	dketchum@bausch.com

Debra Ketchum

3. DEVICE IDENTIFICATION:

Classification Name:	Rigid Gas Permeable (hydrophobic) ContactLens Material
Proprietary Name:	BOSTON XO (hexafocon A) Contact LensMaterial
Common Name:	fluoro silicone acrylate rigid gas permeablecontact lens material

4. PREDICATE DEVICE:

BOSTON ES (enflufocon A) has been selected as the predicate device for BOSTON XO (hexafocon A).

5. DESCRIPTION OF THE DEVICE:

The BOSTON XO Contact Lens Material, hexafocon A, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer.

The color additives conform to 21 CFR part 74.3206. The hexafocon A material has an oxygen permeability, DK of 100, a specific gravity of 1.26, and the lens visible light transmittance of at least 70%. The hexafocon A name has been adopted by the United States Adopted Names Council (USAN).

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6. INDICATIONS FOR USE:

The BOSTON XO contact lens material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfection system only.

Description of Safety and Substantial Equivalence: 7.

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the BOSTON XO contact lens material. The results of all testing demonstrated that the safety and effectiveness of the BOSTON XO is equivalent to the currently marketed BOSTON ES contact lens material. A summary of these results from the preclinical studies is presented below.

Toxicology:

In-Vitro Cytotoxicity:

USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test.

Acute Ocular Irritation:

Acute Ocular Irritation test was performed and produced no ocular irritation.

Systemic Injection

The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic.

Shelf Life:

The BOSTON XO (hexafocon A) is a hydrophobic rigid gas permeable contact lens material with <1% water content. This material will be shipped dry. The data presented supports substantial equivalence of this BOSTON XO (hexafocon A) contact lens material to the already marketed BOSTON ES (enflufocon A) contact lens material. Based on the Premarket Notification Guidance Document for Daily Wear Contact Lenses, May 12, 1994, shelf-life studies are not required for clearance of this material.

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Solution Compatibility:

Studies were conducted on blue tinted lens material with the ultraviolet light absorber. Lenses were run through 30 cycles of cleaning and light uboorben - Establish the compatibility of the lens material with the conditioning to octabligion. The parameters of ultraviolet and visible light (UV/vis) spectra, base curve, lens diameter, power and surface inguality were recorded prior to and upon completion of 30 cycles. Initial quality were rooorded phot to . There were no significant changes to lens parameters after 30 complete cycles.

Clinical Testing

Below is a summary of the clinical study carried out to evaluate the safety and efficacy of the BOSTON XO (hexafocon A) contact lens material and onloady of a daily wear contact lens for the correction of visual acuity.

A total of 128 eyes (64 patients) were entered into the study by 3 Investigators. Prior to entry into this study each patient was required to read and sign a Statement of Informed Consent. All patients who signed a Statement of Informed Consent are accounted for in this report. Of the 128 eyes (64 patients enrolled), 102 eyes (51 patients) completed the study.

The safety and efficacy measures for this study were:

Safety: Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints and Keratometry Changes

Efficacy: Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Lens Deposits, and Lens Wettability.

The sponsor concludes that BOSTON XO (hexafocon A) contact lens material is equivalent in safety and efficacy to the predicate device, Boston ES (enflufocon A).

SUBSTANTIAL EQUIVALENCE 8.

The BOSTON XO contact lens material is substantially equivalent to the currently marketed BOSTON ES contact lens material, which was cleared in 510(k) Premarket Notification No. K943177 on August 25, 1994. The difference between the two devices is a change in the components.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2000

Ms. Debra L.B. Ketchum Manager. Regulatory Affairs Polymer Technology Global Vision Care 1400 N Goodman Street P.O. Box 450 Rochester, NY 14603-0450

Re: K000795 Trade Name: BOSTON XO Contact Lens Regulatory Class: II Product Code: 86 HQD Dated: March 10, 2000 Received: March 13, 2000

Dear Ms. Ketchum:

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 any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Ms. Debra L.B. Ketchum

This letter will allow you to begin marketing your device as described in your 510(k) premarket This icter will anow you to begin massantial equivalence of your device to a legally marketed notification. The PDAT micing of substantial vqur 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 IT you desire specific active for your avicedevices), please contact the Office of Compliance at (301) additionally 807.10 for in neve angilosas on the promotion and advertising of your device, please 571-0119. Tructionally, rol question (301) 594-4639. Also, please note the regulation entitled, contact the Office of Complantee as to should (21CFR 807.97). Other general information Wisoranding by relettine to premained nombailing in the Division of Small Manufacturers On your responsibilities and in 1000 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Brogdon

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

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Polymer Technology 1400 North Goodman Street P.O. Box 450 Rochester, NY 14603-0450

Indications for Use Statement

510(k) Number (if known): k 000795

Device Name:__________________________________________________________________________________________________________________________________________________________________ BOSTON XO

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

Over-The-Counter-Use_

BnJuss

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_k_000 795

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.