(21 days)
Ionofil Plus AC is intended for the restoration of deciduous teeth; Ionofil Plus AC is intended in the restoration of documents in the dental Repair of cuneiform defects and enamel, as well as root erosions in the dental neck area, including class V fillings; Cavities with carious lesions; Filling of class III and small fillings of class I (including extended fissure sealing), and a Filing of class in and omall millings on s cavity lining.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for a dental cement named "Ionofil Plus AC." It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about the acceptance criteria or a study that proves the device meets such criteria in the context of an AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not available in the provided text as it pertains to AI/ML device evaluation.
However, I can extract the "Indications for Use" from the document, which outlines what the device is intended for. This can be seen as a form of "acceptance criteria" for the device's intended use, rather than performance metrics from a clinical study for an AI/ML product.
Here's a breakdown of what can be extracted based on the provided text, and what cannot due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a regulatory approval letter for a dental cement, not an AI/ML device. It does not report performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC).
Instead, the "acceptance criteria" in this context are the "Indications for Use":
| Acceptance Criteria (Indications for Use) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Restoration of deciduous teeth | The device is deemed substantially equivalent for this use. |
| Repair of cuneiform defects and enamel, as well as root erosions in the dental neck area, including class V fillings | The device is deemed substantially equivalent for this use. |
| Cavities with carious lesions | The device is deemed substantially equivalent for this use. |
| Filling of class III and small fillings of class I (including extended fissure sealing) | The device is deemed substantially equivalent for this use. |
| Cavity lining | The device is deemed substantially equivalent for this use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. This information is not provided in a 510(k) clearance letter for a dental material. Clinical study details (sample size, data provenance) are typically found in the 510(k) submission itself or related study reports, not the FDA's decision letter.
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. This document does not describe a study involving human experts establishing ground truth for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe a study involving expert adjudication for an AI/ML device.
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 document is for a dental cement, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a dental cement, not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. This document is for a dental cement, not an AI/ML device. The "ground truth" for a dental cement would be its physical and chemical properties and clinical efficacy, which are evaluated through different types of studies (e.g., in-vitro tests, clinical trials for safety and effectiveness), not typically by expert consensus on data interpretation.
8. The sample size for the training set
Not applicable. This document is for a dental cement, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This document is for a dental cement, not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
VOCO GmbH C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K042669
Trade/Device Name: Ionofil Plus AC Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: September 27, 2004 Received: September 29, 2004
Dear Mr. Shipps
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 - Mr. Shipps
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 contacthe 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/dsma/dsmamain.html
Sincerely yours,
Chin-Lin, Ph.D.
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): K042669 Ionofil Plus AC Device Name: Indications for Use:
lonofil Plus AC is intended for the restoration of deciduous teeth; lonofil Plus AC is intended in the restoration of documents in the dental
Repair of cuneiform defects and enamel, as well as root erosions in the dental neck area, including class V fillings;
Cavities with carious lesions;
Cavities with carlous lesions,
Filling of class III and small fillings of class I (including extended fissure sealing),
Filling of class III and small fillings of class and a Filing of class in and omall millings on s cavity lining.
AND/OR x Prescription Use _ (Part 21 CFR 801 Subpart D)
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)
Susan Curry
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: FO42669
Page 1 of 1
§ 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.