Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm.

The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed.

The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity and maxillofacial area positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.

AI/ML Overview

The provided document is a 510(k) summary for the Planmed Verity, a Computed Tomography X-ray System. It describes the device, its intended use, and comparisons to a predicate device, but it does not contain a table of acceptance criteria and reported device performance as requested. Therefore, I cannot generate the table or directly answer some of the specific questions about acceptance criteria in numerical detail.

However, I can extract information related to the studies performed and general conclusions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific thresholds or reported numerical device performance against those criteria. It states: "All results were equivalent or slightly better in Planmed Verity than in the predicate device." and "the imaging performance of Planmed Verity was found both substantially equivalent to the predicate device and sufficient for clinical use." Without specific metrics defined in the document, a table cannot be constructed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Description: "A clinical study was completed to evaluate the image quality of Planmed Verity's maxillofacial area. The images for this clinical study were selected from patients imaged as part of normal clinical routine in a university hospital in Finland."
Sample Size: The sample size for this clinical study is not specified in the provided text.
Data Provenance:
- Country of Origin: Finland (university hospital).
- Retrospective/Prospective: The phrasing "selected from patients imaged as part of normal clinical routine" suggests a retrospective collection of images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 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

The document describes a clinical study to evaluate "image quality" and compares the new device to a predicate device, focusing on "imaging performance." It does not mention an AI component or evaluate human reader performance with or without AI assistance. Therefore, an MRMC study comparing human readers with AI assistance was not done based on the provided text.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a CT X-ray system, not an AI algorithm. The performance evaluation would be for the imaging system itself, not a standalone algorithm. The clinical study assessed the "image quality" of the system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document states the clinical study was to evaluate "image quality." It does not explicitly define the "ground truth" method used for this evaluation beyond stating that the "results show that the imaging position... gives a clinically sufficient image quality." This usually implies expert assessment/consensus of the images for diagnostic quality, but the specifics are not detailed.

8. The sample size for the training set

This information is not applicable as the document describes a CT imaging device evaluation, not a machine learning model's training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

May 14, 2015

Planmed Ov % Lars Moring Regulatory Affairs Manager Sorvaaiankatu 7 Helsinki, 00880 FINLAND

Re: K143435

Trade/Device Name: Planmed Verity Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, JAK Dated: April 24, 2015 Received: April 29, 2015

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,

Robert A Ochs

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

Enclosure

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Indications for Use

510(k) Number (if known) K143435

Device Name Planmed Verity

Indications for Use (Describe)

Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area.

The device is to be operated and used by legally qualified health care professionals.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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ENCLOSURE 2 P. 2-1

510(K) SUMMARY

DATE April 24th, 2015

PRODUCT, CLASSIFICATION NAME

Trade Name: Planmed Verity Common Name: Computed Tomography X-ray System Classification Name: Computed Tomography X-ray System Product codes: OAS (primary), JAK (secondary) Class: II Regulation: 21 CFR 892.1750

MANUFACTURER

Planmed Oy Sorvaajankatu 7 00880 Helsinki, Finland Phone: +358 20 7795 300 Fax: +358 20 7795 396 Contact person: Lars Moring

UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)

Planmed USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 894 2200 Fax: (630) 894 4271 Contact person: Bob Pienkowski

INTENDED USE

Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area.

The device is to be operated and used by legally qualified health care professionals.

PRODUCT DESCRIPTION

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ENCLOSURE 2

P. 2-2

The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed.

PREDICATE DEVICE

We consider this product to be similar in design, composition to the following device introduced into commercial distribution after May 28. 1976:

510(k) # K061834 Xoran xCATTM

SUBSTANTIAL EQUIVALENCE

The intended use of Planmed Verity and the predicate device is similar. Planmed Verity is intended to be used for imaging anatomies within upper and lower extremities and maxillofacial area. Intended use of the predicate device covers these same areas. Planmed Verity and the predicate device both utilize cone beam computed tomography technology with substantially equivalent technical characteristics for acquiring 3D image data sets of these anatomical areas.

Non-clinical physical laboratory testing studies were completed for the product to compare the imaging performance of Planmed Verity and the predicate device. This testing included a wide range of different physical evaluations for performance, image quality and dose levels. All results were equivalent or slightly better in Planmed Verity than in the predicate device.

A clinical study was completed to evaluate the image quality of Planmed Verity's maxillofacial area. The images for this clinical study were selected from patients imaged as part of normal clinical routine in a university hospital in Finland. The results show that the imaging position, which is different from the one in the predicate device, gives a clinically sufficient image quality.

The safety of selected patient positioning has been analyzed as a part of the risk analysis. As an outcome it is concluded that the selected design methods ensure that the selected patient positioning for head area imaging is safe when used as labeled. The sitting position and open design of Planmed Verity makes it also easy for the patient to move away from the device whenever needed.

CONCLUSIONS

The intended use and technical characteristics are basically the same for both compared devices. The most evident difference is the patient positioning, which has, however, no notable effects on achieved imaging performance characteristics. Both devices are safe when used as labelled.

Based on the non-clinical and clinical studies the imaging performance of Planmed Verity was found both substantially equivalent to the predicate device and sufficient for clinical use.

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Image /page/5/Picture/0 description: The image shows the word "Planned" in large, bold, black font at the top. Below that, in a smaller font, is the text "ENCLOSURE 2" on one line and "P. 2-3" on the next line. The text is centered on the image.

The comparison demonstrates that Planmed Verity 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.