used for the temporary restoration of inlay and onlay preparations and all kind of temporary fillings. Spacer™ is easy to handle because it is not sticky. Spacer™ has high elasticity and without any debris in the cavity.

AI/ML Overview

The provided text is a 510(k) summary for a dental temporary filling material called "Spacer™" by Vericom Co., Ltd. It focuses on regulatory approval based on substantial equivalence to a predicate device, rather than performance studies with acceptance criteria as typically found in AI/ML medical device submissions. Therefore, many of the requested categories cannot be directly extracted from this document.

Here's an analysis of the available information and what cannot be provided:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria or specific performance metrics like sensitivity, specificity, accuracy, etc. It mentions properties like "easy to handle because it is not sticky" and "high elasticity and without any debris in the cavity," but these are descriptive statements, not quantified performance criteria with acceptance thresholds. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance study results against predefined acceptance criteria in the way an AI/ML device would.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No information about a test set, sample size, or data provenance is provided. This type of information is typically found in performance studies, which are not detailed in this 510(k) summary.

3. 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 applicable. There is no mention of a test set, ground truth establishment, or experts for this device in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no mention of a test set or adjudication method.

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 device is a dental material, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This device is a dental material, not an algorithm.

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

Not applicable. No ground truth is established or discussed for this dental material.

8. The sample size for the training set:

Not applicable. There is no training set discussed for this dental material; it's a physical product.

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

Not applicable. There is no training set or ground truth established for it.

Summary

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Vericom Co. Ltd. র বাংলাদেশের মাধ্যমে আর অনেক সামগ্রীর সম্পাদক মেয়া হয়ে পারে প Healthy and beautiful teeth with Vericom

510(k) Summary

SEP 2 8 2007

K072069

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 2007

Company making the submission:

	Submitter
Name	VERICOM Co., Ltd.
Address	#606, 5th Dongyoung Venturestel 199-32, Anyang 7-Dong,Manan-Gu, Anyang-Si, Gyeonggi-Do,Republic of Korea 430-817
Phone	+82 31 441-2881
Fax	+82 31 441-2883
Contact	Myung-Hwan Oh

Device :

Proprietary Name - Spacer™ Common Name - Temporary Filling Materials Classification Name - Material, Tooth Shade, Resin

1. Predicate Device : Clip, VOCO GMBH, K926418

Description :
used for the temporary restoration of inlay and onlay preparations and all kind of temporary fillings. Spacer™ is easy to handle because it is not sticky. Spacer™ has high elasticity and without any debris in the cavity.

Indication for use :

Temporary restoration of inlay and onlay preparations
Temporary fillings and sealings

606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea

Image /page/0/Picture/19 description: The image shows a logo for a company called "VERICOM" that produces dental materials. The logo is in black and white and features the company name in a stylized font. The words "Dental materials" are printed in a smaller font below the company name. The logo has a curved shape.

013

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2007

Dr. Albert Rego Consultant Vericom Company, Limited 27001 La Paz Road, Suite 312 Mission Viejo, California 92691

Re: K072069

Trade/Device Name: Spacer™ Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG, EBF Dated: September 8, 2007 Received: September 18, 2007

Dear Dr. Rego:

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. Rego

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.

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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Indications for Use

510(k) Number (if known)

Spacer™ Device Name:

Indication for use:

Temporary restoration of inlay and onlay preparations
Temporary fillings and sealings

Prescription Use
(21CFR801 Subpart D)
OR

Over-The-Counter Use (21CFR801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Gunne

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

510(k) Number: ko 72069

Vericom Co., Ltd.

Indication for use Page # 1 of 1

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.