(40 days)
Manufacture of all-ceramic inlays, onlays, crowns, and veneers.
GLASS CERAMICS are classified as Porcelain powder for clinical use ( 21 C.F.R. §872.6660). They are glass ceramic blocks intended to manufacture all-ceramic inlays, onlays, crowns, and vencers. GLASS CERAMICS blocks are available in six colors (A1; A2; A3; A3.5; B3; Enamel) and five sizes (I8, 110, 112, I14, V5-12). Like the predicate devices, the glass ccramic blocks "ProCAD® blocks" and "VITABLOCS® Mark II" and the composite block "Paradigm™ MZ 100" blocks, GLASS CERAMICS blocks are grindable blocks for CAD/CAM systems. The allccramic restoration is produced in the dentist's office using the CEREC® system or in a dental laboratory using CEREC® Inlab; both systems are manufactured by the company Sirona, Bensheim, Germany (K012517). The clinical situation is optically scanned and then processed by the CEREC® 3D software. The restoration is fabricated in the CEREC® grinding unit.
This document is a 510(k) summary for "GLASS CERAMICS," a dental product. A 510(k) submission is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device to existing ones rather than extensive clinical studies or establishing detailed acceptance criteria with performance metrics in the way a novel therapeutic or diagnostic device might.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not typically present in a 510(k) submission for a device like this. The primary "study" is a comparison to predicate devices to demonstrate substantial equivalence in terms of composition, performance data, and indications for use.
Here's an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of a 510(k) for this type of device:
Acceptance Criteria and Study for GLASS CERAMICS (510(k) Summary)
The provided document is a 510(k) submission summary for a dental product, "GLASS CERAMICS." For such a device, the primary "acceptance criterion" for regulatory clearance is demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing comparable composition, performance characteristics, and indications for use. Detailed quantitative performance metrics with acceptance limits and formal clinical studies with specific sample sizes, ground truth establishment, and reader adjudications, as might be found for a diagnostic AI device, are not typically reported in this type of submission.
Here's what can be gathered from the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a material (glass ceramic blocks for dental restorations), the "acceptance criteria" are not quantitative performance metrics in the way one might expect for a diagnostic or therapeutic AI device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices in terms of composition, performance data, and indications for use. The document does not provide a table with specific numerical acceptance criteria and corresponding device performance data for metrics like accuracy, sensitivity, or specificity.
The "reported device performance" is implicitly that it performs comparably to the predicate devices, allowing for the manufacture of all-ceramic inlays, onlays, crowns, and veneers using CAD/CAM systems.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a material equivalence claim, a "test set" and its provenance in the context of clinical performance data are not typically described. The comparison is primarily based on material properties and intended use.
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)
This information is not applicable/not provided for this type of 510(k) submission. There is no mention of a "test set" requiring expert-established ground truth for performance evaluation in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for this type of 510(k) submission.
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
This information is not applicable/not provided. The device is a material for dental restorations, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a material, not an algorithm. Its use involves a human dentist or dental laboratory technician using a CAD/CAM system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. Ground truth in the context of clinical diagnostic accuracy is not typically established for a dental restorative material like this in a 510(k) submission. The "ground truth" for the material's properties would be defined by standard material testing protocols, which are not detailed here.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of an AI algorithm described for this device.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary of the "Study" for this 510(k):
The "study" that proves the device meets the "acceptance criteria" (i.e., substantial equivalence) is a comparison to predicate devices based on:
- Composition: Implied to be comparable to "ProCAD® blocks," "VITABLOCS® Mark II," and "Paradigm™ MZ 100" blocks.
- Performance Data: General statement that "performance data" shows substantial equivalence. Specific data is not detailed in this summary. This would typically involve laboratory testing of material properties (e.g., strength, durability, wear resistance) compared to the predicates.
- Indications for Use: The new device shares the same indications as the predicates: "Manufacture of all-ceramic inlays, onlays, crowns, and veneers."
The conclusion states: "Comparison to the predicate devices for composition, performance data and indications for use shows that GLASS CERAMICS are substantially equivalent to the predicate devices. In summary it can be concluded that safety and effectiveness requirements for GLASS CERAMICS arc fully met." The FDA's letter concurs with this substantial equivalence finding.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 1 8 2006
| Submitter | |
|---|---|
| Company: | 3M ESPE AG |
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, |
| Manager Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | andreas.petermann@mmm.com |
| Date: | December 7, 2005 |
traditional 510(k) GLASS CERAMICS
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| Name of Device | |
|---|---|
| Proprietary Name: | GLASS CERAMICS |
| Classification Name | Porcelain powder for clinical use |
| Common Name: | Glass ceramic blocks |
Predicate Devices:
Lava Ccram™ / Lava Frame™ by 3M ESPE (K0113949) Paradigm™ MZ 100 block by 3M ESPE (K9204259) ProCAD® by Ivoclar Vivadent Inc. (presumably K980986) VITABLOCS® Mark II by VITA Zahnfabrik H. Rauter GmbH & Co. KG (presumably K022408)
Description for the Premarket Notification
GLASS CERAMICS are classified as Porcelain powder for clinical use ( 21 C.F.R. $872.6660). They are glass ceramic blocks intended to manufacture all-ceramic inlays, onlays, crowns, and vencers. GLASS CERAMICS blocks are available in six colors (A1; A2; A3; A3.5; B3; Enamel) and five sizes (I8, 110, 112, I14, V5-12).
Like the predicate devices, the glass ccramic blocks "ProCAD® blocks" and "VITABLOCS® Mark II" and the composite block "Paradigm™ MZ 100" blocks, GLASS CERAMICS blocks are grindable blocks for CAD/CAM systems. The allccramic restoration is produced in the dentist's office using the CEREC® system or in a dental laboratory using CEREC® Inlab; both systems are manufactured by the company Sirona, Bensheim, Germany (K012517). The clinical situation is optically scanned and then processed by the CEREC® 3D software. The restoration is fabricated in the CEREC® grinding unit.
Comparison to the predicate devices for composition, performance data and indications for use shows that GLASS CERAMICS are substantially equivalent to the predicate devices. In summary it can be concluded that safety and effectiveness requirements for GLASS CERAMICS arc fully met.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract lines or strokes, possibly representing people or services. The logo is black and white.
JAN 1 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Dr. Sabine Krischer Regulatory Affairs Specialist 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY
Re: K053438
Trade/Device Name: Glass Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 07, 2005 Received: December 09, 2005
Dear Dr. Krischer:
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. Sabine Krischer
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" (21 CFR 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 S. Lin, PhD
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
K053438 510(k) Number (if known):
Device Name: Glass Ceramics Indications for Use:
Manufacture of all-ceramic inlays, onlays, crowns, and veneers.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 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 Ruanes
A (1) 2 (1) 1) nn of Annot Pasielogy, General Hospital, . Fon Control, Dental Devices
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§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.