KAVO EVEREST TITANBLANK by KAVO AMERICA

The provided text is a 510(k) summary for the KaVo Everest Titanblank, a dental product. It does not describe a study involving device performance, acceptance criteria, or AI/human reader efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on material purity.

Therefore, for aspects related to acceptance criteria, device performance, sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details, the answer is "Not applicable / Not provided in the document."

Here's a breakdown based on the information provided in the document:

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

Acceptance Criteria	Reported Device Performance
Not applicable	Not applicable

Explanation: The document states: "Performance Data: None required. The claim of substantial equivalence is based on purity of the titanium (99.5+%)." This indicates that performance data in the typical sense (e.g., accuracy, sensitivity, specificity) was not part of the submission for this type of device. The acceptance criterion was implicitly the material purity matching or exceeding the predicate device, which is stated as 99.5+% pure titanium. However, a specific "acceptance criterion" value for purity is not explicitly called out as an acceptance criterion.

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

Sample size: Not applicable / Not provided.
Data provenance: Not applicable / Not provided.
Explanation: No test set or associated data is mentioned, as performance data was not required.

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)

Number of experts: Not applicable / Not provided.
Qualifications of experts: Not applicable / Not provided.
Explanation: No ground truth establishment was conducted for a test set, as performance data was not required.

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

Adjudication method: Not applicable / Not provided.
Explanation: No test set or related adjudication process is mentioned.

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

MRMC study: No.
Effect size: Not applicable / Not provided.
Explanation: This device (titanium blanks for dental appliances) is a material, not an AI or imaging device, so an MRMC study comparing human readers with and without AI assistance is not relevant to its approval process.

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

Standalone performance: No.
Explanation: This device is a pure material and does not involve an algorithm or "standalone" performance in the context of AI or diagnostic devices.

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

Type of ground truth: Not applicable / Not provided.
Explanation: The approval is based on material purity, not on establishing a "ground truth" for a diagnostic or AI performance evaluation. The "ground truth" for this device would relate to its chemical composition and physical properties, which are inherent to the material itself, rather than requiring expert consensus or pathology data.

8. The sample size for the training set

Sample size: Not applicable / Not provided.
Explanation: There is no training set mentioned or implied for this type of material device.

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

Method of establishment: Not applicable / Not provided.
Explanation: There is no training set for which ground truth would need to be established.

Summary

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K024214

SECTION 9

MAR 1 % 2003

510(k) SUMMAR Y

This 510(k) summary of safety and effectiveness for KaVo Everest Titanblank is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant: KaVo America 340 East Main Street Address: Lake Zurich, IL 60045 CHEMICHL, AG Manufacturer: Landstrasse 114 P.O. 732 VADUZ, LIECHTENSTEIN GERMANY FL 9490 Contact Person: Ms. Jennifer Pottala 847-550-6800 Telephone: 847-550-6825 (Fax) 800-323-8029 Preparation Date: December 2002 (of the Summary) Device Name: KaVo Everest Titanblank Common Name: Titanium metal for use in dentistry Classification: There is no classification regulation for titanium. Base metal alloy: 21 CFR 872.3710 Base metal alloy: Class II Product Code: EJH Panel: 76 Predicate devices: DC Titan Device description: KaVo Everest Titanblank consists of pure (99.5+%) titanium blanks.. KaVo Everest Titanblank is indicated for use in the preparation or Indications: manufacture of permanent or removable dental appliances.

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KaVo proposes that the KaVo Everest Titanblank distributed in the United States be labeled:

"CAUTION: Federal (US) law restricts the use of this device to sale to or on the order of licensed professionals."

Performance Data: None required. The claim of substantial equivalence is based on purity of the titanium (99.5+%).
Based on the information in the notification KaVo America believes that the CONCLUSION: KaVo Everest Titanblank is substantially equivalent to the claimed predicate, DC Titan.

. . . ...

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2003

Ms. Jennifer Pottala New Product Manager KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047

Re: K024214

Trade/Device Name: KaVo Everest Titanblank Regulation Number: 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: December 20, 2002 Received: December 20, 2002

Dear Ms. Pottala:

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 - Ms. Pottala

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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 7 INDICATIONS FOR USE STATEMENT

KO24214 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: KaVo Everest Titanblank________________________________________________________________________________________________________________________________________

Indications for Use Statement:

KaVo Everest Titanblank is indicated for use in the preparation or manufacture of permanent or removable dental appliances.

KaVo proposes that the materials, when intended for distribution in the United States, be labeled:

CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use / (Per 21 CFR 801.109)

Over-The Counter Use ________________________________________________________________________________________________________________________________________________________

Kein Mulkey for USN

General Hospital.

510(k) Number

Regulation Number and Section

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.