The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three- dimensional (3D) digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

Device Description

The Planmeca ProMax 3D Max or Planmeca Maximity -x-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method. In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain preprogrammed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions in the Planmeca Romexis program (on a separate PC system). Ethernet computer networking technology is used.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Planmeca ProMax 3D Max and Planmeca Maximity devices:

The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive acceptance criteria and exhaustive study results in the manner one might find in a full clinical trial report or a performance study for novel AI/standalone devices.

Here's a breakdown of the requested information based on the provided text, with acknowledgments where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device's performance for the expanded indications (ENT region) is clinically usable and comparable to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Clinically usable diagnostic quality for ENT imaging	Images were reviewed by a specialist and deemed to be of a clinically usable diagnostic quality.
Substantial equivalence to predicate device in technical features	Imaging technology, FOV, imaging parameters, resolution, and other basic characteristics closely match the predicate device. Differences are small and have no practical effect on performance.
Conformance to international performance standards	Both devices conform to given international performance standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document states "clinical images for nose, sinuses, airways, middle ear, temporal bone and vertebrae" were taken, implying a collection of images, but the exact number is not provided.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical images" suggests they were acquired from human subjects, but details are lacking.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: "a specialist" (singular).
Qualifications of Experts: Only stated as "a specialist." No further details (e.g., radiologist, years of experience, specific sub-specialty) are provided.

4. Adjudication Method for the Test Set

Adjudication Method: "a specialist" reviewed the images. This implies a single-reader assessment rather than a consensus or adjudication process involving multiple readers (like 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported or implied. The device is an imaging system, not explicitly an AI diagnostic tool in this context, and the evaluation focused on image quality for diagnostic use.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No, a standalone algorithm-only performance study was not explicitly reported. The evaluation described is of the image acquisition and reconstruction system providing images for human interpretation. The "diagnostic support" refers to the images themselves, not an automated diagnostic algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by expert clinical review. The "specialist" deemed the images to be of "clinically usable diagnostic quality," indicating a subjective expert assessment of the image data for diagnostic purposes, rather than being compared to a higher standard like pathology or long-term outcomes data.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not provided. The document describes a traditional imaging device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable/not provided, as there is no mention of an AI/machine learning training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2016

Planmeca Oy % Lars Moring Regulatory Affairs Manager Asentaiankatu 6 Helsinki, 00880 FINLAND

Re: K160506

Trade/Device Name: Planmeca ProMax 3D Max, Planmeca Maximity Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 2, 2016 Received: May 5, 2016

Dear Lars 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.

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

For

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)	K160506
Device Name	Planmeca ProMax 3D MaxPlanmeca Maximity
Indications for Use (Describe)	The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three- dimensional (3D) digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)	Page 1 of 1
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PSC Publishing Services (301) 443-6740 EF

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510K) SUMMARY

DATE

May 2, 2016

PRODUCT, CLASSIFICATION NAME

Trade name: Planmeca ProMax 3D Max or Planmeca Maximity Common name: Computed tomography x-ray system Classification: OAS, Class II Regulation number: 892.1750

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

The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

PRODUCT DESCRIPTION

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PREDICATE DEVICE

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:

Planmeca ProMax 3D Max # K093590 # K103659 Carestream CS 9300

SUBSTANTIAL EQUIVALENCE

The product is principally just the same as in the previous 510(k) #K093590. The indications for use are expanded to include the ENT area.

The expanded intended use of the Planmeca ProMax 3D Max and the predicate device #K103659 is identical. The compared technical features for imaging technology, FOV, imaging parameters, resolution, and other basic characteristics are matching very closely, and the differences are so small that they do not have any effect on performance in practice. Both devices conform to given international performance standards.

The performance testing for ENT imaging applications was carried out taking clinical images for nose, sinuses, airways, middle ear, temporal bone and vertebrae. The images were reviewed by a specialist and were deemed to be of a clinically usable diagnostic quality.

CONCLUSION

The comparison of characteristics supports substantial equivalence. Planmeca ProMax 3D Max is as safe and effective as the predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.