(42 days)
Materialise's 3Matic is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.
Software for computer assisted design and manufacturing of medical and dental prostheses.
This 510(k) summary for the 3Matic software does not include a detailed study proving the device meets specific acceptance criteria with reported performance metrics. Instead, it relies on substantial equivalence to predicate devices (SimPlant System and Etkon ES-1) without presenting new performance data for 3Matic itself.
Therefore, many of the requested details about acceptance criteria and study design are not available in the provided document.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available (NA) | NA |
| The document states substantial equivalence to predicate devices but does not define specific performance acceptance criteria for 3Matic or report any quantitative performance metrics for the device. |
2. Sample size used for the test set and the data provenance
-
Sample Size (Test Set): NA
-
Data Provenance: NA
The document does not describe any specific test set or data used to evaluate 3Matic's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
-
Number of Experts: NA
-
Qualifications of Experts: NA
As there is no described test set or ground truth establishment, this information is not applicable.
4. Adjudication method for the test set
-
Adjudication Method: NA
No test set or ground truth adjudication process 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
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MRMC Study: No.
-
Effect Size: NA
The document does not mention any MRMC study or an assessment of human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
-
Standalone Performance Study: No.
No standalone performance study is described for the 3Matic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
-
Type of Ground Truth: NA
No ground truth is described as having been used to evaluate 3Matic.
8. The sample size for the training set
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Sample Size (Training Set): NA
The document does not provide details about a training set for the 3Matic software.
9. How the ground truth for the training set was established
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Training Set Ground Truth Establishment: NA
No training set or its ground truth establishment is described.
Summary of the Document's Approach:
The provided 510(k) summary for the Materialise 3Matic system establishes its safety and effectiveness through substantial equivalence to existing predicate devices (SimPlant System and Etkon ES-1). This means that the manufacturer asserted, and the FDA agreed, that the 3Matic device is as safe and effective as the predicate devices because it shares similar technological characteristics and is intended for the same use.
This regulatory pathway typically does not require new clinical or performance studies if the differences from the predicate device do not raise new questions of safety or effectiveness. Therefore, the document focuses on demonstrating these similarities rather than presenting novel performance data for 3Matic itself against predefined acceptance criteria.
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KD 60950
AY 1 8 2006
SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE SIMPLANT SYSTEM
Proprietary Name:
3Matic
COMMON NAME:
Software for computer assisted design and manufacturing of medical and dental prostheses
Classification Name:
Picture Archiving and Communications System
DEVICE CLASSIFICATION:
21 CFR 892.2050.
REGULATORY CLASS:
Class II
Classification Product Code:
LLZ
SUBSEQUENT PRODUCT CODES:
NOF
SUBMITTER'S NAME AND ADDRESS:
MATERIALISE N. V. Technologielaan 15 B-3001 LEUVEN, BELGIUM
ESTABLISHMENT REGISTRATION NO:
3003998208
Contact Person: Carl Van Lierde, Materialise N.V.
Quality Manager
Summary Preparation Date: March 21, 2006
Predicate Device
3Matic is claimed to be substantially equivalent in material, design, and function to the SimPlant System, which was cleared by FDA under 510(k) K033849 on May 25, 2004.
3Matic is claimed to be substantially equivalent in material, design, and function to the Etkon ES-1 product from Etkon, which was listed with FDA on January 4, 2005.
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Indications for Use
Materialise's 3Matic is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.
STERILIZATION
The 3Matic is provided non-sterile.
SUBSTANTIAL EQUIVALENCE
The 3Matic is considered to be substantially equivalent to the SimPlant System and Etkon ES-1.
CONCLUSION
The 3Matic is considered to be substantially equivalent in design, material and function to the SimPlant System and Etkon ES-1.
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Food and Drug Administration. 9200 Corporate Blvd. Rockville MD 20850
MAY 1 8 2006
Mr. Carl Van Lierde Quality Manager Materialise NV Medical Division Technologielaan 12, Leuven 3001 BELGIUM
Re: K060950
Trade/Device Name: 3Matic Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 27, 2006 Received: April 6, 2006
Dear Mr. Van Lierde:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health
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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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 06 0950
Indications for Use
510(k) Number (if known):
Device Name: 3Matic
Indications For Use:
Materialise's 3Matic is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR
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)
David a. Lyomm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).