(179 days)
The NobelProcera IPS e.max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.
NobelProcera IPS e.max CAD Crowns are core superstructures intended for the fabrication of crowns. They are made of lithium disilicate glass-ceramic using a wax-up or CAD design technique.
The Nobel Biocare IPS e.max CAD core superstructure can be designed using traditional wax-up t no nove or using Nobel Biocare crown design software. The core superstructure can be designed using the final anatomic shape or a cut-back technique. Wax-up designs are scanned at the laboratory. Both scanned wax-up and CAD designed core superstructure design information is transmitted electronically to the Nobel Biocare manufacturing facility. The core superstructures are manufactured using CAM techniques and delivered to the laboratory for finishing.
The provided text describes a 510(k) premarket notification for a dental device, the NobelProcera IPS e.max Crown. It does not contain information about a study with acceptance criteria and reported device performance in the context of AI/ML or diagnostic performance. Instead, it focuses on the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence for regulatory approval.
Here's a breakdown based on the information provided and what is missing regarding the requested criteria:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not describe specific numerical acceptance criteria or performance metrics for diagnostic accuracy, sensitivity, specificity, or similar measures typically found in performance studies for AI/ML devices. The "performance" mentioned refers to mechanical testing of the material.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing. No test set, clinical data, or patient data (retrospective or prospective) is described for evaluating the device's diagnostic or clinical performance in the context of your typical AI/ML study. The determination of safety and effectiveness was based on "Non-clinical test data," which refers to mechanical testing.
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)
- Missing. This information is not applicable as no test set requiring expert ground truth or diagnostic assessment is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Missing. Not applicable, as no test set requiring expert adjudication 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
- Missing. No MRMC study or AI assistance is mentioned. This device is a physical dental crown, not an AI/ML diagnostic tool for which such studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. Not applicable, as this is a physical dental device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Instead of "ground truth" for a diagnostic task, the "truth" for this device's safety and effectiveness was established through non-clinical mechanical testing (e.g., aging, biaxial, static, and dynamic load tests) of the material. The conclusion hinges on demonstrating its mechanical properties are comparable to or better than predicate devices.
8. The sample size for the training set
- Missing. Not applicable, as this is a physical device and no AI/ML model or training set is involved.
9. How the ground truth for the training set was established
- Missing. Not applicable, as no training set or AI/ML model is involved.
Summary of Device Acceptance and Study:
The NobelProcera IPS e.max Crown is a physical dental device (core superstructure for crowns) and its "acceptance" for regulatory purposes (510(k) clearance) was based on demonstrating substantial equivalence to existing legally marketed predicate devices (Procera Copings and Pontic, IPS e.max CAD/IPS e.max Zircad).
The "study" that proves the device meets the acceptance criteria (i.e., is safe and effective for its intended use) was non-clinical mechanical testing of the e.max material. These tests included aging, biaxial (ISO 6872), static, and dynamic load tests. The objective was to confirm the material's strength to withstand anticipated mastication forces. The document explicitly states: "Non-clinical test data was used to support the decision of safety and effectiveness."
No clinical trials, human reader studies, or AI/ML performance evaluations were conducted or are relevant for this type of device and regulatory submission.
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510(k) Summary of Safety and Effectiveness 1.4
AUG 2 0 2010
| Submitted by: | Herbert CraneDirector, Global Requlatory Affairs |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-5074 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | February 19, 2010 |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660)Product code EIH |
| Trade or Proprietaryor Model Name: | NobelProcera IPS e.max Crown |
| Legally Marketed Device(s): | Procera Copings and Pontic (K032562)IPS e.max CAD/IPS e.max Zircad (K051705) |
Device Description:
イン
NobelProcera IPS e.max CAD Crowns are core superstructures intended for the fabrication of crowns. They are made of lithium disilicate glass-ceramic using a wax-up or CAD design technique.
The Nobel Biocare IPS e.max CAD core superstructure can be designed using traditional wax-up t no nove or using Nobel Biocare crown design software. The core superstructure can be designed using the final anatomic shape or a cut-back technique. Wax-up designs are scanned at the laboratory. Both scanned wax-up and CAD designed core superstructure design information is transmitted electronically to the Nobel Biocare manufacturing facility. The core superstructures are manufactured using CAM techniques and delivered to the laboratory for finishing.
Indications for Use:
The NobelProcera IPS e max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.
Non-Clinical Testing
Nobel Biocare has performed mechanical testing of the e.max material including ageing, biaxial (ISO 6872), static, and dynamic load tests to ensure the product will be strong enough to withstand the anticipated mastication forces.
Clinical Testing
Non-clinical test data was used to support the decision of safety and effectiveness.
Conclusions
The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate devices.
Nobel Biocare USA Traditional 510(k) Notification NobelProcera IPS e.max Crown February 2010
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Substantial Equivalence Comparison to Predicate Devices
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| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE |
|---|---|---|---|
| Anatomical Site | Nobel Procera IPS e.maxCrown | Procera Copings and Pontic(K032562) | IPS e.max CAD/IPS e.max Zircad(K051705) |
| - Oral Cavity | - Oral Cavity | - Oral Cavity | |
| Material | Lithium disilicate ceramic(IPS e.max CAD blocks) | Aluminum oxide- Zirconium oxide | Lithium disilicate ceramic- Zirconium oxide |
| Indications for Use | The Nobel Procera IPS e.maxCrown is indicated for use ascore structures of crownsthat will be cemented tonatural or artificial toothabutments in the treatment ofpartially edentulous patientsas an aid in prostheticrehabilitation. | Nobel Biocare's Procera®Copings and Pontic are indicatedfor use as core structures of anartificial prosthesis, i.e. a three-unit bridge, for partiallyedentulous patients in the need ofprosthetic oral reconstruction inorder to restore chewing function.The Pontic is indicated as thecore structure of the center unitand the Copings are indicated asthe core structures of the two sidecrowns, thereby forming thethree-unit bridge.- The Copings are alsoindicated for use as singlecrowns that will be cementedto a natural or artificial toothabutment in the treatment ofpartially edentulous patientsin order to restore chewingfunction. | IPS e.max CAD is a CAD/CAMmachinable glass ceramic basedon lithium disilicate for thepreparation of full ceramiccrowns, inlays, onlays, and fullceramic 3-unit anterior bridges.IPS e.max ZirCAD consists ofmachinable zirconia blocks forthe preparation of full ceramiccrowns, onlays and 3- and 4-unitbridges and inlay bridges(anterior and molar). |
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nobel Biocare AB C/O Mr. Herbert Crane Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
AUG 2 0 2010
Re: K100512
Trade/Device Name: NobelProcera IPS e.max Crown Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: July 27, 2010 Received: July 28, 2010
Dear Mr. Crane:
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 ffor 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 mav, 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- Mr. Crane
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 vours.
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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Indications for Use
510(k) Number (if known):
Device Name: NobelProcera IPS e.max Crown
Indications For Use:
The NobelProcera IPS e.max Crown isindicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.
Prescription Use × (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)
Kio Muly Cm MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1
510(k) Number: K100512
§ 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.