(90 days)
Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
The Planmeca ProMax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
This document is a 510(k) summary for the Planmeca ProMax 3D Mid, an X-ray system. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria.
Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific performance metrics. The document is a regulatory submission for premarket notification, establishing "substantial equivalence" to predicate devices. It does not contain the detailed technical performance data typically found in a clinical or standalone performance study report.
Therefore, I cannot populate the requested table or provide answers to most of the questions as the information is not present in the provided text.
Here's an overview of what can be extracted based on your request, highlighting the missing information:
1. A table of acceptance criteria and the reported device performance
- No information provided. The document does not specify any quantitative acceptance criteria or report performance metrics (e.g., sensitivity, specificity, resolution, image quality scores) against such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided. No test set or data provenance is mentioned as there is no performance study described.
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)
- No information provided. Ground truth establishment for a test set is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information provided. 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
- No information provided. This device is an X-ray imaging system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No information provided. This is an imaging device, not an algorithm, so this concept is not applicable in this context. No standalone performance data is presented.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- No information provided. No ground truth is discussed as no performance study is detailed.
8. The sample size for the training set
- No information provided. No training set is mentioned.
9. How the ground truth for the training set was established
- No information provided. No training set or ground truth establishment is mentioned.
Summary of available information relevant to regulatory submission:
- Device Name: Planmeca ProMax 3D Mid
- Manufacturer: Planmeca Oy (Helsinki, Finland)
- Intended Use: Panoramic and cephalometric x-ray unit using Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of human teeth, jaws, and skull. Operated by dentists and other legally qualified healthcare professionals.
- Product Description: Conventional digital panoramic/tomography X-ray system with a 3D CBVT add-on. Rotates around the patient, takes still images with a flat panel sensor, and reconstructs a 3D volume image for viewing.
- Predicate Devices:
- Regulatory Classification: Class II, Product Code MUH, Regulation Number 872.1800 (Extraoral Source X-Ray System)
- 510(k) Number: K103689
- Date of Submission: December 14, 2010
- FDA Clearance Date: March 17, 2011
The document's purpose is to demonstrate that the Planmeca ProMax 3D Mid is "similar in design, composition and function" and "as safe and effective" as the predicate devices, thereby establishing substantial equivalence for regulatory clearance without requiring a new, full-scale performance study to meet specific acceptance criteria.
{0}------------------------------------------------
KI 0.3689
PLANMECA
ENCLOSURE 12
P. 12-1
510K) SUMMARY
MAR 1 7 2011
DATE December 14, 2010
PRODUCT, CLASSIFICATION NAME
Trade name: Planmeca ProMax 3D Mid Common name: Tomography x-ray system Classification: MUH, Class II Regulation number: 872.1800
MANUFACTURER
Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Fax: +358 20 7795 396 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)
Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person : Bob Pienkowski
INTENDED USE
Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
PRODUCT DESCRIPTION
The Planmeca ProMax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
{1}------------------------------------------------
PLANMECA
ENCLOSURE 12
P. 12-2
P. 2 of 2
SUBSTANTIAL EQUIVALENCE
We consider this product modification to be similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:
| # K060328 | Planmeca ProMax 3D |
|---|---|
| # K093590 | Planmeca ProMax 3D Max |
The comparison of characteristics supports substantial equivalence. Planmeca ProMax 3D Mid is as safe and effective as the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu 6 Helsinki, Finland F1-00880
MAR 1 7 2011
Re: K103689
Trade/Device Name: Planmeca Promax 3D MID Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: II Product Code: MUH Dated: December 14, 2010 Received: December 17, 2010
Dear Mr. Moring:
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.
{3}------------------------------------------------
Page 2- Mr. Moring
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 yours
Susan Tunne
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
{4}------------------------------------------------
KI03689
p. 11-1
p:1-of1
Indications for Use
510{k) Number (if known):
Device Name:
Planmeca Promax 3D Mid
Indications For Use:
Planmeca Promax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
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 Ruriner
510(k) Number
Page 1 of _
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.