Ceramir Crown & Bridge is a hybrid glass ionomer-ceramic dental cement. The liquid and powder are packed are in a capsule format. The capsule is activated and the powder and liquid is mixed in a mixer before use.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way typically found for AI/ML devices.

Instead, this document is a 510(k) summary for a dental cement called Ceramir® Crown & Bridge. The core of its approval is based on demonstrating substantial equivalence to a predicate device, XeraCem™.

Here's a breakdown of why the requested information cannot be fully provided based on the input:

Device Type: The device described is a dental cement, not an AI/ML diagnostic or measurement device. Therefore, the concepts of "test set," "ground truth," "experts," "adjudication," "MRMC studies," or "standalone performance" as they relate to AI/ML devices are not applicable here.
Performance Data Basis: The approval hinges on the new device being "technologically identical" to its predicate device (XeraCem™) in terms of powder and liquid composition and the proportion of these components in the mixed cement. The differences are in packaging and mixing format (capsule vs. hand-mixed).
"Studies have proven the properties...to be substantially equivalent": This is a general statement. The document does not detail specific studies, their methodology, sample sizes, or acceptance criteria in the context of quantitative performance metrics for AI/ML. It refers generally to "properties, including biocompatibility."

Therefore, I cannot populate the table or answer most of your specific questions as they relate to the performance evaluation of an AI-based system.

However, I can provide the following based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (XeraCem™)	Ceramir® Crown & Bridge is "technologically identical" to its predicate device, XeraCem™. The powder and liquid are identical. The proportion between amount of powder and amount of liquid is the same. "Studies have proven the properties, including biocompatibility of the cement to be substantially equivalent to the predicate device."
Same Intended Use as Predicate Device	Ceramir® Crown & Bridge has the same intended use as its predicate device.
Safe and Effective as Predicate Device	Ceramir® Crown & Bridge is "as safe and effective as the predicate device and performs as well as the predicate device."

Explanation: For this type of device (a dental cement), the "acceptance criteria" for regulatory clearance are primarily demonstrating substantial equivalence to a previously cleared product. This means showing that the new device is as safe and effective as the predicate device for its indicated uses, and that any technological differences do not raise new questions of safety or effectiveness. The reported performance is that it meets this standard by being "technologically identical" in crucial aspects and having "substantially equivalent" properties.

The other points are not applicable or cannot be answered from the provided text for this specific device.

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

Not Applicable: This information is not provided because the approval is based on substantial equivalence to a predicate device, not on specific performance metrics derived from a "test set" in the context of an AI/ML algorithm.

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 "ground truth" establishment in the context of expert review for an AI/ML algorithm for this dental cement.

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

Not Applicable: No test set or expert adjudication process for an AI/ML algorithm is described.

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 is a physical dental cement, not an AI-assisted diagnostic tool.

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

Not Applicable: This is a physical dental cement, not an algorithm.

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

Not Applicable: There is no "ground truth" as typically understood for AI/ML devices. The "truth" for this device's performance is established by demonstrating its material properties are equivalent to the predicate device.

8. The sample size for the training set

Not Applicable: This device is not an AI/ML algorithm that requires a training set.

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

Not Applicable: This device is not an AI/ML algorithm that requires a training set or ground truth establishment in that context.

Summary

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K100510

Doxa

13 510(k) Summary

MAR 2 5 2010

13.1 Submitter and manufacturer

Doxa Dental AB Axel Johanssons qata 4-6 SE 754 51, Uppsala, Sweden Phone: +46 18 478 000: Fax: +46 478 001

Contact: Margareth Jorvid, Doxa Dental AB, Axel Johanssons gata 4-6 SE 754 51, Uppsala, Sweden Phone: +46 70 519 2640 Fax: +46 18 478 2001 E-mail: Margareth.jorvid@lsmgroup.se

13.2 Date of Submission

February 18th, 2010

13.3 Device Name

Trade name Ceramir® Crown & Bridge

Common or Usual Name Dental Cement

Classification name

Dental cement other than zinc oxide-eugenol (21 CRF 872.3275)

Product Code

EMA

13.4 Predicate Devices

Trade name	510(k) holder	510(k) No.
XeraCemTM	Doxa Dental AB	K081405

13.5 Indications for Use

Ceramir Crown & Bridge is intended for the permanent cementation of

Porcelain Fused to Metal Crowns and Bridges .
Metal (gold etc.) crowns and bridges .
. Gold inlays and onlays
. Cast or prefabricated metal posts

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. Strengthened core all-zirconia or all-alumina ceramic crowns and bridges

13.6 Technological characteristics

13.7 Performance Data

Ceramir Crown & Bridge is technologically identical to its predicate device. The powder and liquid are identical. The proportion between amount of powder and amount of liquid is the same in the mixed cement. The packaging format and mixing differs; XeraCem is hand mixed while Ceramir Crown & Bridge is packed and mixed in a capsule format. Studies have proven the properties, including biocompatibility of the cement to be substantially equivalent to the predicate device.

13.8 Substantial Equivalence

Ceramir Crown & Bridge is as safe and effective as the predicate device and performs as well as the predicate device. Ceramir Crown & Bridge has the same intended use and technological characteristics as its predicate device.

In summary, the dental luting cement Ceramir Crown & Bridge described in this submission is, in our opinion, substantially equivalent to the predicate device, XeraCem.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Margareth Jorvid Regulatory Affairs Doxa Dental AB Axel Johanssons, Gata 4-6 Uppsala Sweden SE-754 51

MAR 2 5 2010

Re: K100510

Trade/Device Name: Ceramir Crown & Bridge Regulation Number: 21CFR 872,3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 19, 2010 Received: March 22, 2010

Dear Ms. Jorvid:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Jorvid

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K100510

16.4 Attachment 4: Indications for Use, Ceramir Crown & Bridge

Indications for Use, Ceramir Crown & Bridge

510(k) Number:

Device Name: Ceramir Crown & Bridge

Indications for Use:

Ceramir Crown & Bridge is intended for the permanent cementation of

Porcelain Fused to Metal Crowns and Bridges ●
Metal (gold etc.) crowns and bridges .
Gold inlays and onlays
Cast or prefabricated metal posts
Strengthened core all-zirconia or all-alumina ceramic crowns and bridges ●

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R&Atoons for Dr KPMuller

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

510(k) Number: K100510

Special 510(k) Ceramir Crown & Bridge

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.