Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

Device Description

The Planmeca Viso -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 (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). 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 pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Planmeca Viso, a CT X-ray system. However, the document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving the device meets those criteria, as would typically be seen in a clinical performance study for an AI/CAD device.

The document primarily compares the technical characteristics and intended uses of the Planmeca Viso with its predicate device (Planmeca ProMax 3D Max) and reference devices. It states that "Results from performance bench testing demonstrate that Planmeca Viso produces substantially equivalent image quality compared to the predicate and reference devices," but does not provide specific acceptance criteria or the details of these performance bench tests.

Therefore, based on the provided text, it is not possible to fully answer all aspects of your request, especially regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment in a clinical performance study context for an AI device. The document is a regulatory clearance letter, not a detailed study report.

However, I will extract and infer what information is available and highlight what is missing.

Acceptance Criteria and Device Performance (based on provided text):

The document does not explicitly state quantitative acceptance criteria or corresponding device performance in a table format for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and image quality as determined through "performance bench testing."

Acceptance Criterion (Inferred from document's purpose)	Reported Device Performance (as stated in document)
Substantial Equivalence:	"Planmeca Viso is as safe and effective as the predicate device."
Image Quality:	"Results from performance bench testing demonstrate that Planmeca Viso produces substantially equivalent image quality compared to the predicate and reference devices."
Intended Use:	"The Indications for Use (IFU) for the subject device are the same as those for the predicate device."
Technological Characteristics:	Comparable technological characteristics (CBCT, 2D imaging, X-ray tube, detector, software) to the predicate device are presented in Table 1.

Study Details (as much as can be inferred from the provided text):

Sample size used for the test set and the data provenance:
- The document mentions "performance bench testing" but does not specify the sample size of images or patients used for these tests.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document refers to "diagnostic support for pediatric and adult patients" at the "direction of healthcare professionals," but it does not detail the process of establishing ground truth for evaluating device performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided.
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 does not describe an MRMC study or any AI components, nor does it discuss human reader improvement with or without AI assistance. The device is a "Computed tomography x-ray system" (hardware).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document focuses on the imaging system itself (hardware) rather than an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable or discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided. For an imaging device, ground truth for image quality often involves quantitative metrics (e.g., spatial resolution, contrast-to-noise ratio, dose efficiency) derived from phantoms or objectively evaluated clinical images against a reference standard, but the specific methods are not detailed here.
The sample size for the training set:
- This information is not applicable as the document describes a hardware device (CT X-ray system), not a machine learning/AI algorithm that would typically have a "training set."
How the ground truth for the training set was established:
- This information is not applicable for the same reason as above.

Summary of Missing Information (Critical for a complete answer to your prompt):

The provided document is a 510(k) clearance letter for an imaging device (Planmeca Viso). It confirms the device's substantial equivalence to a predicate device. It lacks the detailed clinical study information (acceptance criteria, specific metrics, sample sizes, ground truth establishment, expert involvement, and reader studies) that would typically be required for evaluating the performance of an AI-driven diagnostic device. The "performance data" mentioned is stated to be from "bench testing" demonstrating image quality equivalence, rather than a clinical performance study with human readers or diagnostic accuracy metrics.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

September 13, 2018

Planmeca Oy Lars Moring Regulatory Affairs Specialist Asentajankatu 6 FI-00880 Helsinki FINLAND

Re: K181576

Trade/Device Name: Planmeca Viso Regulation Number: 21 CFR 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: August 15, 2018 Received: August 17, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Rodgers

Digitally signed by Jeffrey J. Ballyns -S DN· c=US o=US Government ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=20005697 25, cn=Jeffrey J. Ballyns -S Date: 2018.09.13 16:30:25 -04'00'

for Robert A. Ochs, Ph.D. 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) K181576

Device Name Planmeca Viso

Indications for Use (Describe)

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)

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510K) SUMMARY

I. SUBMITTER

MANUFACTURER

Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Contact person: Lars Moring

U.S. DESIGNATED AGENT

Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 894 2300 Contact person : Bob Pienkowski

Date prepared: September 7, 2018

PRODUCT, CLASSIFICATION NAME II.

Name of the device: Common or Usual Name: Classification name: Requlatory Class: Product Code: 510(k) number:

Planmeca Viso Computed tomography x-ray system Computed tomography x-ray system (21 CFR 892.1750) -OAS #K181576

III. PREDICATE DEVICE

Planmeca ProMax 3D Max #K160506

IV. REFERENCE DEVICE

Planmeca ProMax 3D Mid #K103689 RAYSCAN A-EXPERT 3D, #K142247

V. DEVICE DESCRIPTION

VI. INDICATIONS FOR USE

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

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The Indications for Use (IFU) for the subject device are the same as those for the predicate device.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both devices are 3D CBCT imaging system indicated for imaging dento-maxillofacial-, cervical spine- and ENT-regions and offer a variety of 3D fields of view suitable for each application. Both systems also provide 2D imaging capabilities, predicate device only for panoramic and Planmeca Viso both for panoramic and cephalometric imaging.

Both systems are based on fixed anode X-ray tube and a flat panel detector of the same technology. Pixel sizes of the detector differ but voxel sizes on resulting 3D images are the same." Tube voltage range with Planmeca Viso is wider and ranges up to 120kV, providing users with option to utilize even higher X-ray penetration when necessary.

	Planmeca Viso	Predicate device Planmeca ProMax3D Max
Intended use	Planmeca Viso is a system intended toproduce two-dimensional (2D) andthree-dimensional (3D) digital x-rayimages as well as three-dimensional(3D) optical images of the dento-maxillo-facial, cervical spine and ENT(Ear, Nose, and Throat) regions at thedirection of healthcare professionals asdiagnostic support for pediatric andadult patients.	The Planmeca ProMax 3D Max orMaximity is a system intended producetwo-dimensional (2D) and three-dimensional (3D) digital X-ray images othe dento-maxillo-facial, cervical spineand ENT (Ear, Nose and Throat)regions at the direction of healthcareprofessionals as diagnostic support forpediatric and adult patients.
3D Imaging
Technicalcharacteristics	• CBCT (cone beam computedtomography)• 300 - 600 projections over 210° / 360°rotation• Reconstruction time 30 s - 6 min• Voxel size 75-600µm	• CBCT (cone beam computedtomography)• 300 - 600 projections over 210° / 360°rotation• Reconstruction time 30 s - 6 min• Voxel size 75-600µm
Field Of View (FOV)	Ø30x30mm - Ø200x170mm (G5) /Ø300x300mm (G7)	Ø42x48mm - Ø230x260mm
2D Imaging
Technology	• SmartPan panoramic imaging,tomosynthesis• Multiview panoramic imaging,tomosynthesis• Cephalostat	• SmartPan panoramic imaging,tomosynthesis• Multiview panoramic imaging,tomosynthesis• No cephalostat
Imaging systemperformancespecifications
X-ray detector	• Varex Imaging 16x16cm flat panel(G5) / 25x30cm flat panel detector(G7)• aSi with Csl scintillator• 127µm pixel pitch (G5) / 139µm pixelpitch (G7)• Bit depth 16bit• Varian PaxScan 2530C30.2(w)x24.9(h)cm• GADOX scintillator	• Varex Imaging 25x20cm flat paneldetector• aSi with Csl scintillator• 127µm pixel pitch• Bit depth 15bit

Table 1: Comparison with predicate device

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X-ray tube andgenerator
	• Fixed anode X-ray tube focal spot size 0.5 mm• Tube voltage 60-120 kV• Tube current 1-16 mA• Exposure time 0.1–36 sec (pulsed)	• Fixed anode X-ray tube with 0.6mm focal spot• Tube voltage 66-96 kV• Tube current 1-12,5 mA• Exposure time 3–24 sec (pulsed)
Other
Workflow	• Open positioning, doctor facing the patient• Patient seated or standing	• Open positioning, doctor facing the patient• Patient seated or standing
Imaging Software	• Planmeca Romexis	• Planmeca Romexis

Cephalometric scanning feature and detector are identical to those in previously cleared reference devices. The PaxScan 2530C, used for cephalometric imaging in the subject device, was included as a cephalometric detector in a previously cleared 510(k) for the RAYSCAN a-Expert 3D (K142247).

VIII. PERFORMANCE DATA

Results from performance bench testing demonstrate that Planmeca Viso produces substantially equivalent image quality compared to the predicate and reference devices.

IX. CONCLUSIONS

The comparison of characteristics supports substantial equivalence. Planmeca Viso 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.