(34 days)
Planmeca Promax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. 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 professionals.
The Planmeca Promax 3D is in principle a conventional digital panoramic x-ray system with three-dimensional Cone Beam Computed Tomography (CBCT) 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.
The provided document is a 510(k) summary for the Planmeca Promax 3D, a Cone Beam Computed Tomography (CBCT) x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, several requested sections, particularly those pertaining to detailed study design, sample sizes, and expert adjudication, are not explicitly available in the provided text.
Specifically, K060328 is a 510(k) premarket notification for a new device, and its purpose is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (3D Accu-i-tomo XYZ Slice View Tomograph # K052587). This process typically involves showing that the new device is as safe and effective as the predicate device, often through comparison of design, composition, and technological characteristics, and sometimes through performance data if there are significant differences. However, the exact "acceptance criteria" in the sense of a numerical performance threshold and a detailed study proving the device meets those criteria in an independent clinical trial is not part of this 510(k) summary as provided.
Here's an attempt to answer the questions based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria with numerical thresholds or report detailed device performance metrics against such criteria. The "acceptance criteria" in the context of this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary from Document) |
|---|---|
| Similar in design, composition, and function | "similar in design, composition and function to the... predicate device." (Section: SUBSTANTIAL EQUIVALENCE) |
| As safe and effective as the predicate device | "Planmeca Promax 3D is as safe and effective as the predicate device." (Section: SUBSTANTIAL EQUIVALENCE) |
| Intended Use | "intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." (Section: INTENDED USE) |
| Technology | "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." (Section: INTENDED USE) |
2. Sample size used for the test set and the data provenance
Not specified. The provided document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a study assessing the device's performance against defined acceptance criteria. The claim of substantial equivalence is made based on design and functional similarity to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. As no specific "test set" or explicit ground truth establishment process is detailed in the provided 510(k) summary, information regarding the number or qualification of experts for this purpose is absent.
4. Adjudication method for the test set
Not applicable/Not specified. There is no mention of a test set or an adjudication method in the provided document.
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. The document describes an x-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not specified. This is a hardware device (x-ray system), not an algorithm or AI. Standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used
Not specified. Given that no specific study with defined acceptance criteria and performance data is detailed, the type of ground truth used is not mentioned. The submission relies on claiming equivalence to a predicate device already on the market.
8. The sample size for the training set
Not applicable/Not specified. This is a medical imaging device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI development is not relevant to this 510(k) submission and no information is provided.
9. How the ground truth for the training set was established
Not applicable/Not specified. As this is not an AI/ML device, the concept of a training set and its ground truth establishment is not applicable.
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PLANMECA
ENCLOSURE 12
P. 12-1
KOGO328
MAR 1 5 2006
510K) SUMMARY
DATE February 7, 2006
PRODUCT, CLASSIFICATION NAME
Trade name: Planmeca Promax 3D Common name: Panoramic/Tomography x-ray system Classification: 76 EHD, 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, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. 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 professionals.
PRODUCT DESCRIPTION
The Planmeca Promax 3D is in principle a conventional digital panoramic x-ray system with three-dimensional Cone Beam Computed Tomography (CBCT) 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.
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SUBSTANTIAL EQUIVALENCE
We consider this product modification including a new 3D CBCT x-ray system to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:
3D Accu-i-tomo XYZ Slice View Tomograph # K052587
The comparison of characteristics supports substantial equivalence. Planmeca Promax 3D is as safe and effective as the predicate device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu 6 FI-00880 Helsinki FINLAND
Re: K060328 Trade/Device Name: Planmeca Promax 3D Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral source x-ray system Regulatory Class: II
Product Code: MUH Dated: February 7, 2006 Received: February 9, 2006
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 mav, 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.
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 CJFR 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.
Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
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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 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 irom 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. Bigelow
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):
Planmeca Promax 3D Device Name:
Indications For Use:
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is reconstructed to be viewed in 3D viewing stations welf on is reconstructed to be views the research and other legally qualified 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)
Eötvös L. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Page 1 of 1_
§ 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.