(85 days)
The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.
The provided text is a 510(k) summary for "The InSync Ceramic System" by Jensen Industries. It is a premarket notification to the FDA for a dental porcelain product.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document states: "Independently, the InSync Ceramic System meets the applicable sections of concensus standards ISO 9693 and ISO 6872."
The text does not provide a table of specific numerical acceptance criteria from ISO 9693 and ISO 6872, nor does it report specific numerical device performance against those criteria. It only makes a general statement of compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing or the data provenance. It refers to "Data has been presented to demonstrate that the respective composition, mechanical properties, chemical qualities, and the indications for use make the InSync Ceramic System substantially equivalent to the predicate devices," but no details of this data or its origin are provided.
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 provided in the document. The study described is a comparison of material properties, not an evaluation requiring expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided in the document as it describes a study of material properties, not a study requiring adjudication of expert interpretations.
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
An MRMC comparative effectiveness study was not done. This document describes a dental porcelain system, and the study focuses on its material properties and chemical qualities, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study as typically understood for AI algorithms was not conducted. The device itself is the material (dental porcelain), not an algorithm. The "study" described is the testing of the material's properties against established consensus standards (ISO 9693 and ISO 6872) and comparison to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the material property comparison would be defined by the consensus standards (ISO 9693 and ISO 6872) for mechanical and chemical properties of dental ceramics. The performance of the device (its material properties) is compared against the specifications within these standards and against the properties of the predicate devices.
8. The sample size for the training set
The document does not mention a training set, as this is not an AI/machine learning device. The "training" in this context would be the development and formulation of the ceramic system itself, not a data-driven training process.
9. How the ground truth for the training set was established
The concept of a "training set" and "ground truth for the training set" as it relates to AI/machine learning is not applicable to this device or its reported data. The "ground truth" for the material's development would be established through established scientific principles of material science, chemistry, and engineering validated by industry standards (like ISO).
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Image /page/0/Picture/0 description: The image shows the logo for Jensen Dental. The logo consists of a stylized water droplet shape on the left, followed by the word "JENSEN" in large, bold, sans-serif font. Below the word "JENSEN" is the word "DENTAL" in a smaller, simpler font.
i
1 4 2011
Section E
510(k) SUMMARY
| Submitted by: | Jensen Industries50 Stillman RoadNorth Haven CT 06473(203) 239-2090 phone(203) 234-7630 faxContact: Gary Phelps |
|---|---|
| Date Prepared: | June 14, 2011 |
| Device Name: | The InSync Ceramic System |
| Common Name: | Dental Porcelain |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660) |
| Classification: | Class II |
| Product Code: | EIH |
Predicate Devices
| Ceramics 2in1: 510(k) number K043221 | |
|---|---|
| Willi Geller Creation CP - ZI: 510(k) number K070114 |
Device Description
The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.
Indications for use
The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
Comparison to predicate devices
Data has been presented to demonstrate that the respective composition, mechanical properties, chemical qualities, and the indications for use make the InSync Ceramic System substantially cquivalent to the predicate devices Willi Geller Creation CP-Zi and Ceramics 2in1porcelains The safety and effectiveness of the InSync Ceramic System, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices. Independantly, the InSync Ceramic System meets the applicable sections of concensus standards ISO 9693 and ISO 6872.
(3)
50 Stillman Road, North Haven, CT 06473 JENSEN DENTAL
(203) 239-7630 Fax (203) 239-2090 www.jensendental.com (800) 243-2000
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that resemble snakes intertwined around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gary Phelps Quality Assurance Manager Jensen Industries. Incorporated 50 Stillman Road North Haven. Connecticut 06473
SEP 14 200
Re: K111743
Trade/Device Name: The InSync Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EHH Dated: June 06, 2011 Received: June 21, 2011
Dear Mr. Phelps:
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 111 (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. Phelps
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 331-542 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.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/acm115809.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.lda.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.hun.
Sincerely vours.
hh 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 Radiolo@ical Health
Enclosure
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Indications for Use
510(k) Number (if known):
K | | 743
Device Name: The InSync Ceramic System
Indications for Use: The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
Prescription Use X AND/OR (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 Rooney
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111743
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(2)
§ 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.