(130 days)
The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.
The Zfx Dental CAD system is software that is used to design dental restorative prosthetic devices from digital optical impressions. The software receives topographical characteristics of dental impressions or stone models from a compatible scanning system. The design created in the software is complied into a format enabling manufacturing of a patient specific component at Zimmer Dental. The CAD software is pre-installed on a Windows compatible computer system.
Here's an analysis of the acceptance criteria and study information for the Zfx Dental CAD System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which often focuses on substantial equivalence to predicate devices rather than formal acceptance criteria and detailed clinical study results for a new medical device claiming performance improvements. As such, some of the requested information (like specific quantifiable acceptance criteria, effect sizes, and detailed ground truth acquisition for training data) is not present in this type of submission.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Ability to accept digital scan files from a compatible dental scanner. | System demonstrated acceptance of digital scan files from a compatible dental scanner. |
| Ability to design a patient-specific restoration (e.g., abutment, crown, bridge). | System demonstrated the ability to design patient-specific restorations (abutments, crowns, bridges). |
| Ability for Zimmer to manufacture the patient-specific restoration to the required design specifications. | Verification testing conducted to confirm patient-specific restorations can be manufactured by Zimmer to required design specifications. |
| Software, hardware, and integration verification and validation in accordance with FDA guidance. | Verification and validation testing performed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" sample size in terms of number of patient cases or designs.
- The testing described is verification and validation, implying an internal product development and testing process, rather than a clinical trial with a patient-specific test set.
- Data provenance is not specified regarding country of origin or whether it was retrospective/prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Since no clinical testing was performed, and the testing was focused on software and manufacturing capabilities, the concept of "ground truth" as established by medical experts for diagnostic accuracy doesn't directly apply in the way it would for an AI-diagnostic device. The "ground truth" for the device's function would be its adherence to design specifications and manufacturing capabilities.
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Adjudication method for the test set:
- Not applicable as this was not a clinical study involving human interpretation of medical images or data requiring adjudication. The verification and validation process would involve internal engineering and quality assurance checks against design requirements.
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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:
- No MRMC comparative effectiveness study was done.
- This device is a CAD system for designing dental prosthetics, not an AI-powered diagnostic or interpretation tool for human readers. Its function is to facilitate design, not to assist in human diagnostic decisions.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the "standalone" performance is the device's function. The Zfx Dental CAD System is software that takes digital input and allows a user to design restorations. The verification and validation testing assesses the software's ability to perform these functions accurately (i.e., accept files, allow design, output files for manufacturing). It does not involve a human in a diagnostic loop that would be compared to an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the verification and validation, the "ground truth" would be the design specifications and manufacturing requirements established by Zimmer Dental for patient-specific restorations. The system's output (digital designs) and the subsequent manufactured physical restorations would be compared against these established specifications for accuracy and adherence.
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The sample size for the training set:
- This information is not provided. The Zfx Dental CAD System is described as CAD software for design, not as a machine learning model that undergoes a training phase with a distinct training set of data. Its functionality likely relies on algorithms based on geometric principles and dental design rules, rather than statistical learning from a large training dataset.
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How the ground truth for the training set was established:
- Not applicable as the device is not described as a machine learning system requiring a labeled training set with established ground truth in the typical sense. The "ground truth" for developing such software would be established by engineering requirements, dental prosthetic design principles, and industry standards.
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Image /page/0/Picture/1 description: The image shows a logo for Zimmer Dental. The logo consists of a circle with the letter 'Z' inside, followed by the word 'zimmer' in a stylized font. Below 'zimmer' is the word 'dental' in a smaller, simpler font.
Zfx Dental CAD System
Zimmer Dental
510k No.:
Page No .: . A5-1
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
OCT 19 2012
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
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- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave.Carlsbad, CA 92008 |
| Phone: | 760-929-4300 |
| Contact: | Cecilia Silva |
Date Prepared: October 18, 2012
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- Device Name:
| Trade Name: | Zfx Dental CAD System |
|---|---|
| Regulation Number: | 872.3630 / 872.3661 |
| Classification Code: | NHA / NOF |
| Device Classification Name: | Endosseous Dental Implant Abutment / Optical Impression Systems for CAD/CAM |
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- Predicate Device(s):
Trade Name: etkon™ visual, etkon™ es1, Straumann CARES Regulation Number: 872.3630 / 872.3661 Classification Code: NHA / NOF Device Classification Name: Endosseous Dental Implant Abutment / Optical Impression Systems for CAD/CAM
- Predicate Device(s):
র . Device Description:
The Zfx Dental CAD system is software that is used to design dental restorative prosthetic devices from digital optical impressions. The software receives topographical characteristics of dental impressions or stone models from a compatible scanning system. The design created in the software is complied into a format enabling manufacturing of a patient specific component at Zimmer Dental. The CAD software is pre-installed on a Windows compatible computer system.
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Zfx Dental CAD System zummer dental
510(k) No. A5-2 Page No.
5. Indications for Use:
The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.
Device Comparison: റ.
The new device is substantially equivalent to the predicate relative to the software that allows a digital design of patient specific ("customized") abutments, crown, bridge, and components, and the operating software that controls a scanner. The function and intended use of the dental CAD system remains equivalent to the predicate device.
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Zfx Dental CAD System
zomomo@gr
dental
510(k) No. A5-3 Page No. _____________________________________________________________________________________________________________________________________________________________________
-
- Technological Characteristics
| Feature/Components | New Device | Predicate |
|---|---|---|
| Zfx Dental CAD System | etkonTMes1etkonTM_visualStraumann CARES | |
| Indication | The Zfx Dental CAD System isintended to allow the user toacquire patient specific data via ascan or digital file and define theshapes of dental prosthetic devicessuch as dental abutments, crowns,bridges, copings, in-lays, on-lays,and veneers through the use of a3D-CAD tool. Zfx Dental CADSystem creates an output file of therestorations designed by the userthat can be manufactured using aCAM system. | etkon_visual is a software deviceintended to import patient-specificdata from a scanner for CAD(computer aided design) design ofindividual dental restorations likecrowns, bridges, inlays, onlays,veneers and abutments.etkon_visual also facilitates thetransfer of 3D data from a dentallab to a remote milling center byinternet connection and serves asan order management tool. |
| Input | STL file from a scanner | STL file from a scanner |
| Design Options | Dental prosthetic devices:Abutments, crowns, bridges,copings, in-lays, on-lays andveneers. | Individual Dental Restorations:Crowns, bridges, inlays, onlays,veneers and abutments. |
| Output | STL file to a Zimmer Dental millingcenter | STL file to a Straumann CAD/CAMmilling center |
| PC/Monitor | Provided as part of the System | Provided as part of the System |
| Network Cables | Provided as part of the System | Provided as part of the System |
| GUI/OS | Windows®7 64 bit OperatingSystem | Windows®7 64 bit OperatingSystem |
Non-Clinical Testing: 8.
- a) Verification and Validation Testing
.
Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005).
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with the letter Z inside, above the word "zimmer" with a line underneath, and the word "dental" below the line. The text is in a simple, sans-serif font.
Zfx Dental CAD System
510(k) No. Page No. _____________________________________________________________________________________________________________________________________________________________________ A5-3
Verification and validation testing of the Zfx Dental CAD system has been completed. Validation testing has been conducted to demonstrate that the Zfx Dental CAD system can accept a digital scan file from a compatible dental scanner, and design a patient specific restoration, such as an abutment, crown, or bridge. Verification testing has been conducted to verify that a patient specific restoration can be manufactured by Zimmer to the required design specifications.
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ത് Clinical Testing
No clinical testing was performed. -
- Conclusion
Based on our analysis, the device is substantially equivalent to the predicate.
- Conclusion
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer Dental, Incorporated
Ms. Cecilia Silva
Regulatory Affairs
1900 Aston Avenue
Carlsbad, California 92008
OCT 19 2012
Re: K121709
Trade/Device Name: Zfx Dental CAD System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, NOF Dated: September 17, 2012 Received: September 18, 2012
Dear Ms. Silva:
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. Silva
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.
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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Image /page/6/Picture/1 description: The image shows a logo for Zimmer Dental. The logo consists of a circle with the letter "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Below "zimmer", the word "dental" is written in a smaller, sans-serif font.
Indications for Use
21700
510(k) Number (if known):
Device Name: Zfx Dental CAD System
Indications For Use:
The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runez
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121709
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)