VELscope is to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities by exciting the tissue with blue light and allowing the direct visualization of the resulting natural tissue fluorescence. VELscope is complimentary to and is intended to be used in combination with a traditional oral mucosal examination with white light.

VELscope is intended to be used by a dentist or heatth-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities.

Device Description

VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.

The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.

AI/ML Overview

It appears that the provided text is a 510(k) summary for the VELscope device, which focuses on demonstrating substantial equivalence to a predicate device (Vizilite) rather than a direct study proving specific acceptance criteria for the new device. As such, many of the requested data points for a clinical or performance study proving acceptance criteria are not present in this document.

However, I can extract the information that is available and highlight what is not provided based on the context of a 510(k) summary.

Analysis of the Provided Text for Acceptance Criteria and Study Details:

The 510(k) summary for VELscope (K060920) explicitly states that the device is "substantially equivalent to Vizilite" and details the similarities and minor differences. It does not provide a standalone study with defined acceptance criteria for the VELscope itself. Instead, it relies on the predicate device's existing market clearance.

The document mentions: "NIH funded scientific studies provide evidence to support that VELscope is effective in enhancing the visualization of oral mucosal abnormalities." However, it does not provide details about these studies, their design, or their specific findings in the context of acceptance criteria for the VELscope device.

Therefore, for many of your specific requests (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details for training/test sets), the information is not available in this 510(k) summary. These details would typically be found in a separate clinical study report or a more detailed performance evaluation document that a 510(k) summary often references but doesn't fully reproduce.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (as per this document)
Enhancement of identification and visualization of oral mucosal abnormalities.	"NIH funded scientific studies provide evidence to support that VELscope is effective in enhancing the visualization of oral mucosal abnormalities." (This is a general statement of effectiveness, not a quantifiable performance metric or a specific criterion met by the VELscope's own detailed study in this document).
Substantial equivalence to predicate device (Vizilite).	The device is deemed "substantially equivalent" to the Vizilite (K003995). The differences noted are: 1. VELscope doesn't require acetic acid rinse. 2. VELscope uses a metal halide light for blue light, while Vizilite uses chemiluminescent diffused blue-white light. 3. VELscope uses filters to block reflected blue light for natural tissue fluorescence visualization.
Function similarly and used for the same purpose as Vizilite.	"The VELscope functions similarly and is used for the same purpose as the Vizilite device."

Missing Information from the Provided Text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions "NIH funded scientific studies" but doesn't detail their methodology, sample size, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 provided. This device is an adjunctive light system, not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. VELscope is a direct visualization system intended to be used by a human practitioner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device with a distinct "training set" in that sense. The efficacy relies on bio-fluorescence properties of tissue.
How the ground truth for the training set was established: Not applicable.

Summary of Study (as per the 510(k) document):

The 510(k) for VELscope relies on establishing substantial equivalence to the predicate device, Vizilite, and general statements about "NIH funded scientific studies" supporting its effectiveness. It does not present a detailed, standalone clinical study with specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies for the VELscope device itself within this document. The FDA's letter confirms substantial equivalence based on the provided information, allowing it to market the device.

Summary

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K060920

Section 5 - 510(k) Summary

ילי" ליינו 17 מינו

Submitter's Name: David Morgan, PhD

201-15047 Marine Dr. Address: White Rock, BC V4B 1C5 Canada

Date of Submission: March 31st 2006

Contact Person: David Morgan, PhD

(604) 541-4614, ext. 262 Phone:

E-mail: david.morgan@led-md.com

(604) 541-4613 Fax:

Device Name: VELscope

Common Name: Oral Examination Light

Classification Name: Operating Light, Dental

Marketed Device of Equivalence: Vizilite

Description of Device:

VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.

Intended Use:

Characteristics of VELscope compared to Predicate Device:

The VELscope System is substantially equivalent to Vizilite, manufactured by Zila, Inc. The 510(k) number of the predicate device is K003995.

Dated: 3/31/2006

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The VELscope functions similarly and is used for the same purpose as the Vizilite device.

Vizilite uses a 1% acetic acid mouth rinse prior to examination. An acetic acid rinse is not necessary for the use of the VELscope system.

Vizilite uses a chemiluminescent light source that produces a diffused blue-white light. The VELscope system uses a metal halide light to produce a blue light that is directed into the mouth via the VELscope Handpiece.

Essentially, the only difference between the VELscope system and the predicate device is that the VELscope system uses filters to block the reflected blue light to allow the visualization of the natural tissue fluorescence.

Clinical Studies:

NIH funded scientific studies provide evidence to support that VELscope is effective in enhancing the visualization of oral mucosal abnormalities.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2006

Dr. David C. Morgan Senior Vice President Product Development Led Medical Diagnostics, Incorporated #210-15047 Marine Drive White Rock, British Columbia V4B 1C5

Re: K060920

Trade/Device Name: VELscope Regulation Number: 872.6350 Regulation Name: Ultraviolet detector Regulatory Class: II Product Code: NXV Dated: March 31, 2006 Received: April 4, 2006

Dear Dr. Morgan:

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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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 continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Snute y. Michael Oms.

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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K060920

Indications for Use

510(k) Number (if known):

Device Name: VELscope

Indications For Use:

VELscope is intended to be used by a dentist or heatth-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Suza Quarty

Dogv Gene

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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.