(166 days)
The SimPlant system is indicated for use as a is a medical front-end software that can be used The SimPlant system is Indicated for use as a 15 a modion frages. It is indication a software interface and image segmentation system for the transfer of imaging information a soltware interface and inlage segments or a Magnetic Resonace scamer. It is also from a medical scanner such as a CT seamer or a magical implant placement and surgical treatment.
The Materialise SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as a software for simulating / evaluating dental implant placement and surgical treatment options.
This appears to be a 510(k) clearance letter from the FDA for the SimPlant System, and it describes the device, its indications for use, and its substantial equivalence to previously cleared devices. However, this document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.
The nature of a 510(k) submission, especially an older one like this (2004), often relies on demonstrating substantial equivalence to a predicate device rather than presenting new, extensive performance studies with detailed acceptance criteria as one might see for a PMA or more modern 510(k)s.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.
Here's what I can extract based on the information provided, and where information is missing:
1. Table of acceptance criteria and the reported device performance
- Information Missing: This document does not specify any quantitative acceptance criteria or report device performance against such criteria. The clearance is based on substantial equivalence.
2. Sample size used for the test set and the data provenance
- Information Missing: The document does not describe a "test set" or any performance study data as part of this 510(k) submission that would require a sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Information Missing: This information is not present as no test set or ground truth establishment process is described.
4. Adjudication method for the test set
- Information Missing: No adjudication method is described.
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
- Information Missing: No MRMC study or any study involving human readers or AI assistance is mentioned. The device is described as "image processing system" and "preoperative software," not an AI diagnostic tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information Missing: No standalone performance study is described. The device's clearance is predicated on substantial equivalence, implying its performance is comparable to its predicates, not independently verified via a specific study detailed here.
7. The type of ground truth used
- Information Missing: No ground truth is described as no performance study is detailed.
8. The sample size for the training set
- Information Missing: No training set is mentioned. This is a software device cleared via 510(k) through substantial equivalence, not a machine learning model developed with a training set.
9. How the ground truth for the training set was established
- Information Missing: No training set or ground truth for it is mentioned.
Summary of what the document does provide context for:
- Device Name: SimPlant System
- Intended Use: Software interface and image segmentation system for transfer of imaging information from medical scanners (CT, MR) and for simulating/evaluating dental implant placement and surgical treatment options.
- Regulatory Clearance: 510(k) clearance based on substantial equivalence to predicate devices (SIM/Plant product K924810 and CT-Modeller K970617).
- Date of Clearance: May 25, 2004.
To obtain the detailed performance study information you are looking for, one would typically need to review the full 510(k) submission, which is not fully provided here, or look for published clinical studies related to the device, especially if it were a newer, AI-driven device. For older devices cleared via substantial equivalence, detailed performance studies as described in your request were often not a prerequisite for clearance in the way they might be today.
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MAY 2 5 2004
SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE SIMPLANT SYSTEM
Ko 33849
PROPRIETARY NAME
SimPlant System
COMMON NAME:
Image processing system and preoperative software for simulating /evaluating dental implant placement and surgical treatment options
CLASSIFICATION NAME:
This product uses images acquired from Computerized System, Image Processing. Tomography (CT) scanners.
DEVICE Classification
This device has been classified as Class II.
REGULATORY CLASS:
Class II
Product Code
LLZ
MATERIALISE N.V. SUBMITTER'S NAME AND ADDRESS: Technologielaan 15 B-3001 LEUVEN, BELGIUM Applied for ESTABLISHMENT REGISTRATION NO: Carl Van Lierde, Materialise N.V. Contact Person: Quality Manager
November 28, 2003 SUMMARY PREPARATION DATE:
Predicate Device
The SimPlant System is claimed to be substantially equivalent in material, design, and function to the SIM/Plant product which was acquired by Materialise from Columbia Scientific, Inc. and cleared by FDA under 510(k) K924810 on January 15, 1993.
The SimPlant System is claimed to be substantially equivalent in material, design, and function to the CT-Modeller product from Materialise which was cleared by FDA under 510(k) K970617 on April 21, 1997
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DEVICE DESCRIPTION
The Materialise SimPlant System is intended for use as a software interface and The Materialise offinitiation system for the transfer of imaging information from a medical image segmentation of over a Magnetic Resonance scanner. It is also intended scanner odon as a c rovare for simulating / evaluating dental implant placement and surgical treatment options.
STERILIZATION
The SimPlant System is provided non-sterile.
INDICATIONS FOR USE
The Materialise SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical image sogmentation on a Magnetic Resonance scanner. It is also intended scanner suomas a of 50amfor en a ulating / evaluating dental implant placement and surgical treatment options.
SUBSTANTIAL EQUIVALENCE
The SimPlant System is considered to be substantially equivalent to the SIM/Plant product and to the CT-Modeller System.
CONCLUSION
The SimPlant System is considered to be substantially equivalent in design, material and function to the SIM/Plant product and the Ct-Modeller System
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Mr. Carl Van Lierde Quality Manager Materialise N.V. Technologielaan 15 3001 Leuven BELGIUM
Re: K033849
Trade/Device Name: SimPlant System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: April 6, 2004 Received: April 8, 2004
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 (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
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
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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 premainted 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 11 you t the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. lxxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
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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Indications for Use
510(k) Number (if known): _K033849
Device Name: SimPlant System________________________________________________________________________________________________________________________________________________
Indications for Use:
The SimPlant system is indicated for use as a is a medical front-end software that can be used The SimPlant system is Indicated for use as a 15 a modion frages. It is indication a software interface and image segmentation system for the transfer of imaging information a soltware interface and inlage segments or a Magnetic Resonace scamer. It is also from a medical scanner such as a CT seamer or a magical implant placement and surgical treatment.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
(Division Sign Division of Reproductive, and Radiological Device 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).