INDICATIONS FOR USE: The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

Device Description

The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

AI/ML Overview

The provided document, K080043, is a 510(k) summary for ViziLite Eyewear, indicating FDA clearance based on substantial equivalence to a predicate device. This type of submission focuses on demonstrating equivalence rather than comprehensive clinical efficacy studies with predefined acceptance criteria. Therefore, the document does NOT contain the detailed information requested in the prompt regarding acceptance criteria, extensive clinical trial data, or detailed ground truth methodologies that would typically be found in a PMA (Premarket Approval) submission or a more rigorous clinical study report.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly define quantitative acceptance criteria or report specific device performance metrics in the format of a table as typically seen in efficacy studies. The "performance" described is in the context of its intended use to reduce ambient light effects.

Acceptance Criteria (Implied)	Reported Device Performance
Primary: Ability to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available.	The "Instructions for Use" state: "The reusable ViziLite eyewear, as supported by clinical testing, allows a trained health care professional the option to use the evewear throughout the ViziLite Plus with TBlue Oral Lesion Marking Procedure for oral chemiluminescent examination without the need for darkening a room and without altering safety and efficacy." The eyewear is designed to "allow transmission of 430-580nm light," which aligns with the chemiluminescent light source (ViziLite) it's designed to be used with. The functional performance is that it enables the procedure to be performed effectively without a darkened room.
Secondary: Not altering safety and efficacy of the ViziLite Plus with TBlue procedure.	"without altering safety and efficacy."
Functional: Allows transmission of light in the 430-580nm range.	"The ViziLite Eyewear has been designed to allow transmission of 430-580nm light."

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

The document explicitly mentions "clinical testing" in the "Instructions for Use" section but does not provide details about the sample size (number of patients or cases) of the test set.
Data provenance (e.g., country of origin, retrospective or prospective) is not specified.

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 any information on the number of experts used or their qualifications to establish ground truth for any test set. The phrase "trained health care professional" is used in the instructions for use, implying clinical judgment, but no details on expert panels for ground truth determination are given.

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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 comparative effectiveness study is mentioned. The device is an optical filter (eyewear), not an AI-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The comparison is between performing the ViziLite procedure with the eyewear vs. requiring a darkened room, and maintaining diagnostic performance.

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

This question is not applicable as the ViziLite Eyewear is a passive optical filter designed for human use, not a standalone algorithm.

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

The document does not explicitly state the type of ground truth used for its "clinical testing." Given the context of oral lesion identification, clinical assessment and possibly biopsy/histopathology would be the typical ground truth in such evaluations, but this is not detailed.

8. The sample size for the training set

The document does not mention a training set sample size. As this is a 510(k) for an optical accessory, a "training set" in the machine learning sense is not applicable. If "training set" refers to data used to initially establish the eyewear's specifications or demonstrate its function, those details are not provided.

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

This question is also not applicable for the same reasons as point 8.

Summary

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K080043

172

SECTION 12 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS APR - 4 2008

K080043 ViziLite Eyewear

Submitter's Name: Gary Klinefelter

Address: 5227 North 7th Street

Phoenix, AZ 85014-2800

Phone: 602-266-6700

Fax: 602-234-2318

Consultant: Suzanne Parisian, M.D.

MD Assist, Inc.

Device Name: ViziLite Eyewear

Common Name: Oral Examination Light

Classification Name: Operating Light, Dental

Substantial Equivalence: ViziLite Blue Oral Exam Product

1. INTENDED USE:

The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam.

INDICATIONS FOR USE: INDICATIONS FOR USE:

Instructions for Use "VIZILITE EYEWEAR"

The reusable ViziLite eyewear, as supported by clinical testing, allows a trained health care professional the option to use the evewear throughout the ViziLite Plus with TBlue Oral Lesion Marking Procedure for oral chemiluminescent examination without the need for darkening a room and without altering safety and efficacy.

Date of Submission: March 24, 2008

Contact: Mark Bride, DDS

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K080043

2 of 2

Following a conventional oral exam with ambient light, the trained health care professional can put on the ViziLite Eyewear for the ViziLite Plus with TBlue Oral Lesion Marking Procedure to improve oral mucosal lesion identification, evaluation and monitoring in patients at increased risk for oral cancer. The "ViziLite" is the system's chemiluminescent light source used for identification and evaluation of oral mucosal changes which can include atypia, dysplasia, leukoplakia, erythroplakia, genetic change or occult lesions.

While still wearing the ViziLite Eyewear, oral lesions identified by ViziLite can be marked using the TBlue Oral Lesion Identification and Marking System to help preserve the anatomic characteristics. The marking dye, when positive, acts as a lesion marker allowing removal of the ViziLite while preserving the anatomic characteristics of the lesion. Whether a lesion marks with dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination.

The ViziLite Eyewear can be worn throughout the ViziLite and TBlue Oral Lesion Marking procedure without interfering with the examination.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2008

Mark Bride, DDS Vice President, Medical Affairs Zila, Incorporated 5227 North 7th Street Phoenix, Arizona 85014-2800

Re: K080043

Trade/Device Name: VIZILITE EYEWEAR Regulation Number: 872.6350 Regulation Name: Dental Operating Light Regulatory Class: II Product Code: NXV Dated: March 25, 2008 Received: March 27, 2008

Dear Dr. Bride:

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, 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 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.

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Page 2 - Dr. Bride

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.

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 (240) 276-0115. 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,

Suitt. Y. Mckinzie Ovid.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 1- INDICATIONS FOR USE

K080043

510(k) Number: K080043

Device Name: VIZILITE EYEWEAR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	X
(Per 21 CFR 801.109)
OR	Over-The-Counter Use ___________
	(Optional Format 1-2-96)

Signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control & Dental Devices

510(k) Number	K080043
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Regulation Number and Section

§ 872.6350 Ultraviolet detector.

(a)
Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.(b)
Classification. Class II.