ORTOMED is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthognathic surgery treatment planning and communication as well as case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.

Device Description

Ortomed is an imaging software designed for use by specialized dental practices for capturing, storing and presenting patient's dental images and for assisting in treatment planning and case diagnosis, specifically cephalometric tracing for orthodontic and orthognathic cases. Results produced by the software's diagnostic and treatment planning tools must be interpreted by the trained, licensed practitioner. The software features and capabilities include image and management using the Gesden database and Gesimag image management suite and also specific cephalometric analysis functions and treatment simulation. Features and capabilities include:

Cephalometric landmarking and analysis: lateral, frontal, models and soft profile -
Analysis of models: Bolton, Moyers, Dentoalveolar discrepancy analysis -
Lateral tracing superimposition, overlays on patient images -
-CO/CR conversion, growth forecasts, simulation of facial profile growth
VTO (Visual Treatment Objective) treatment simulation for orthodontic cases -
STO (Surgical Treatment Objective) treatment simulation for orthognathic surgical cases -
-Simulation and display of VTO/STO treatments using warping and morphing.

AI/ML Overview

This document is a 510(k) premarket notification from INFOMED SERVICIOS INFORMATICOS S.L. for their device, ORTOMED. The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

The document discusses the device's intended use, its comparison to predicate devices (Dolphin Imaging 11.5 and CS Orthodontic Imaging/CS OMS Imaging Software), and a summary of non-clinical data used to support the submission.

Crucially, this document is a 510(k) premarket notification. It does NOT describe a study that explicitly proves the device meets specific acceptance criteria based on quantifiable performance metrics with a defined test set, ground truth, or expert review process as would be expected for a typical AI/ML device approval.

Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices. This means that the testing performed, primarily non-clinical, aimed to show that the new device has similar technological characteristics and performs comparably to the predicate devices, and that it introduces no new or increased risks.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present or applicable in the way they would be for a typical performance-based evaluation of an AI/ML diagnostic tool.

Here's how to address your request based on the provided text, highlighting what is available and what is not:

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

This document does not present a table of specific quantitative acceptance criteria or reported performance metrics in terms of accuracy, sensitivity, specificity, etc., for automated tasks. The regulatory pathway is substantial equivalence, which focuses on demonstrating the new device is as safe and effective as existing legally marketed devices, rather than meeting novel performance thresholds.

The document focuses on comparing features and functionalities with predicate devices to establish equivalence. The "performance" assessment is qualitative in this context, ensuring the software tools produce results that are to be "interpreted by trained and licensed dental practitioners," similar to how predicate devices function.

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

The document primarily relies on "non-clinical test data" for "adequate safety and performance." It does not specify a distinct "test set" in the context of a clinical performance study with patient data. As this is a substantial equivalence submission, rigorous patient-data-based testing with a defined test set and provenance (like retrospective or prospective cohort studies) is typically not required unless new clinical questions or significant technological changes are present. The document focuses on software validation and verification.

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 is provided on expert involvement for "ground truth" establishment, as this type of performance study (e.g., for diagnostic accuracy) was not described. The device's results are intended to be "interpreted by trained and licensed dental practitioners," implying human oversight rather than automated diagnostic claims requiring ground truth for validation.

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

Not applicable, as no clinical performance test set with a need for ground truth adjudication 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

There is no mention of an MRMC study or any study evaluating the effect of AI assistance on human readers. The device is a "Picture archiving and communications system" and "Radiological Image Processing System" with tools for cephalometric analysis and treatment simulation, which imply computational assistance but not necessarily an AI-driven diagnostic aid that would typically warrant an MRMC study for assessing human performance improvement.

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

The document does not describe standalone algorithm performance for diagnostic claims. The Indications for Use explicitly state: "Results produced by the software tools are to be interpreted by trained and licensed dental practitioners." This indicates that the device is an aid to a human practitioner, not a standalone diagnostic tool.

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

Ground truth, in the context of a performance study for an AI/ML diagnostic, is not discussed because no such study is presented for ORTOMED. The "ground truth" for the software's functionality would be its adherence to specified design requirements and accurate execution of its algorithms (e.g., correct calculation of measurements), which are verified through software testing.

8. The sample size for the training set

Not applicable. This is not a description of an AI/ML model development where a "training set" of data would be used to train a machine learning algorithm. The document describes a software system with computational tools (e.g., for cephalometric analysis and treatment simulation) that are based on predefined algorithms and rules, not learned from data.

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

Not applicable for the same reason as point 8.

Summary of Acceptance Criteria and Study (Based on Provided Document):

The "acceptance criteria" for ORTOMED, as implied by this 510(k) submission, are primarily centered on demonstrating substantial equivalence to predicate devices in terms of:

Intended Use: Matching the intended use of existing, legally marketed devices.
Technological Characteristics: Possessing similar fundamental technological features and functionalities.
Safety and Performance: Demonstrating that the device is as safe and effective as the predicate devices, and that it does not introduce new or increased risks.

The "Study" that Proves Acceptance:

The "study" described is the 510(k) submission process itself, which includes:

Non-clinical Data: The documentation states, "Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device."
Design and Development Compliance: The device "has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA guidance documents:
- Guidance for the Submission of Premarket Notifications for Medical Imaging Management Devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Risk Management: "Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971."
Software Lifecycle Processes: "Integration, verification and validation testing have been successfully completed following standard ISO 62304."

In conclusion, this document primarily details a regulatory submission for substantial equivalence based on
non-clinical software verification and validation, rather than a clinical performance study with predefined acceptance criteria and a detailed statistical analysis of AI/ML performance.

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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

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

August 5, 2014

INFOMED SERVICIOS INFORMATICOS S.L.

% Mr. Santiago Sola General Manager Via Augusta 158, 4th Floor 08006 Barcelona SPAIN

Re: K131348 Trade/Device Name: ORTOMED Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 28, 2014 Received: July 31, 2014

Dear Mr. Sola:

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,

Smhff)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131348

Device Name ORTOMED

Indications for Use (Describe)

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

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HENRY SCHEIN®
infomed
Healthcare Software

510(k) Premarket Notification - Ortomed

Section 5 - 510(k) Summary

DATE OF SUBMISSION:	2013-04-23
SUBMITTER NAME:	INFOMED Servicios Informáticos S.L.
SUBMITTER ADDRESS:	Vía Augusta 158, 4th floor08006 BarcelonaBARCELONASPAIN
CONTACT:	Santiago Solà
TELEPHONE:	+34 934 14 4340
Fax:	+34 932 080809
e-mail:	ssola@infomed.es
DEVICE TRADE NAME:	ORTOMED
COMMON NAME.	Radiological Image Processing System

DEVICE TRADE NAME:	ORTOMED
COMMON NAME:	Radiological Image Processing System
CLASSIFICATION NAME:	Radiological Image Processing System (21 CFR 892.2050)
PRODUCT CODE:	LLZ
REGULATION DESCRIPTION:	Picture archiving and communications system

PREDICATE DEVICE(S):	Dolphin Imaging (K110430)CS Orthodontic Imaging and CS OMS Imaging Software (K122427)
----------------------	-------------------------------------------------------------------------------------------

DEVICE DESCRIPTION:

Cephalometric landmarking and analysis: lateral, frontal, models and soft profile -
Analysis of models: Bolton, Moyers, Dentoalveolar discrepancy analysis -
Lateral tracing superimposition, overlays on patient images -
-CO/CR conversion, growth forecasts, simulation of facial profile growth
VTO (Visual Treatment Objective) treatment simulation for orthodontic cases -
STO (Surgical Treatment Objective) treatment simulation for orthognathic surgical cases -
-Simulation and display of VTO/STO treatments using warping and morphing.

SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, the Software ORTOMED is compared with the following previously cleared device:

Dolphin Imaging 11.5 (K110430)
CS Orthodontic Imaging and CS OMS Imaging Software (K122427)

Comparison of the proposed devices with the predicate device is summarized in the following table:

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Characteristic / Feature	Proposed Device	Predicate Device	Predicate Device
	ORTOMED	DOLPHIN IMAGING 11.5	CARESTREAM CS
510(k) number	Pending	K110430	K122427
General Features
Basic Technology Platform	PC-based software application	PC or Mac	IBM-compatible PC or PC network
Operating System	Windows® 2000/XP, Vista andWindows® 7	Windows XP Pro with SP2, 2003 Server, 2008 Server or Windows 7 (supports both 32 and 64-bit versions)	Microsoft Windows
User Interface	Mouse, Keyboard	Mouse, Keyboard	Mouse, Keyboard
Patient Management	GESDEN module for patient registrationand file managementGESIMAG module for imagemanagement.	Imaging Plus Module for patient registrationand file management	-
Charting and Reports	Customizable report contents and imagelayers.Custom formattingMin: 720 dpi color printer	Printer output:Min: 720 dpi color printerRec: 1440 dpi color inkjet or dyesublimination printer	-
Import / Export capabilities	Paper or electronic formats (PDF orimage formats JPEG, PNG, GIF, BMP.Export of complete studies to anexchange file (.OSE). / Import ofpreviously exported studies.	Export to multiple formats, copy images toWindows clipboard, e-mail imagesDICOM support (optional)	Includes DICOM
Patient Database Engine	Microsoft® SQL®	Microsoft® SQL®	SQL
Image Features
Image Input Sources	- Digital Radiology devices connecteddirectly to the computer.- Scanner (TWAIN) with backlightingfor X-rays.- Digital photography (minimum 3MPcamera recommended)- External files from USB. network or	X-rays, slides and other images- Digital x-ray images (optional)- TWAIN -compliant input devices;- Flatbed scanner - min. 150 dpi forx-rays, 300 dpi for photographs and1600 dpi for slides.- Existing files in industry-standard	Images can be scanned, loaded from digitalcameras or card readers, or imported fromspecific interfaced radiographic imagingdevices.
Characteristic / Feature	Proposed DeviceORTOMED	Predicate DeviceDOLPHIN IMAGING 11.5	Predicate DeviceCARESTREAM CS
	digital camera.	image formats- Creates 2D radiographs fromvolumetric CBCT data usingDolphin 3D software (optional)- Digital photography (minimum 3MPcamera recommended)
Image manipulation tools	PreviewRotateEnhance ((brightness, contrast, gamma,hue, saturation)AlignZoom in/out, Brightness, contrast,sharpness, emboss	PreviewCropRotateEnhance (brightness, contrast, gamma, hue,saturation, red-eye reduction)AlignZoom in/out, Brightness, contrast, sharpness,emboss	Greyscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize, flip,mirror, masking, rotate, annotation,cephalometric tracing, ceph growthprojections, implant simulations.
Image Measurement	Yes (linear distance, angle)	Yes (linear distance, angle)	Yes (linear distance, angle)
Matching / Adjustment ofPhotograph to X-ray	Yes	Yes	-
Analytical and Planning Functional Features
Cephalometric Analyses	In addition to user-configured analysis,standard orthodontic tracing analysesinclude:	Both standard and user-configured analysesmay be used.	In addition to user-configured analysis,standard orthodontic tracing analysesinclude:
	Lateral Analyses:- Ricketts- McNamara- Steiner (Tweed)- Jarabak- Roth- Downs- Bjork-Williams- Holdaway	Lateral Analyses:- Ricketts- McNamara- Steiner (Tweed)- Jarabak- Roth- Sassouni- McLaughlin- Downs-Northwestern	- Downs- Jarabek- McNamara- Ricketts- Roth- Sassouni- Steiner- Tweed
Characteristic / Feature	Proposed Device	Predicate Device	Predicate Device
	ORTOMED	DOLPHIN IMAGING 11.5	CARESTREAM CS
	- Burstone-Legan- ... and many more.	- Bjork- Alexander (Vari-Simplex)- Holdaway- Alabama- Burstone- Gerety- ... more than 400 in all
	Frontal Analyses:- Ricketts Frontal- Frontal M.- HSR Panoramic	Frontal Analyses:- Ricketts- Van Arsdale- Grummons- Grummons Simplified
	Models Discrepancy Studies:- Bolton- Moyers- Schwartz-Korkhaus- Transversal- ADS-ADI Cervera	Arch Analysis (Models Study)- Bolton- Schwarz
	Photo studies of soft tissues- Facial profile- Photo/RadiographSuperimposition, Tracing /photo superimposition	Photo Studies of Soft Tissues:- Photo/Radiograph Superimposition,Tracing / photo superimposition
Cephalometric Tracing	- Automatic landmark insertion,- Manual repositioning oflandmarks and control points- Automated tooth andcephalometric structure	- Automated tooth and cephalometricstructure templates	Yes
Characteristic / Feature	Proposed Device	Predicate Device	Predicate Device
	ORTOMED	DOLPHIN IMAGING 11.5	CARESTREAM CS
	templates
	Superimposition of tracings	Superimposition of tracings
Treatment Planning,Simulation and Follow-up	Orthodontic treatment- Translate, tip and rotate- incisors, reposition molars,- auto-rotate mandible- Arch length discrepancy- worksheet- CO/CR Conversion- Growth Forecast (Ricketts algorithm)- Growth simulation on a traced- x-ray or tracing overlaid on- photograph- Superimpose one or more- growth tracings over original- tracing- VTO - Visual Treatment Objective- SVTO - Surgical Visual Treatment- Objective (orthognathic surgery)- Warping and Morphing	Orthodontic treatment- Translate, tip and rotate incisors,- reposition molars, auto-rotate- mandible- Arch length discrepancy worksheet- CO-CR conversion- Growth Forecast (Bolton or Ricketts growth- algorithms)- Growth simulation on a traced x-ray- or tracing overlaid on photograph- Superimpose one or more growth- tracings over original tracing- VTO- SVTO (Orthognathic surgery)- Movie Morphing	Simulated growth projections on lateralphotos used for patient communication.
Implant module	No	Additional module (IMPLANNER™)	Yes - includes implant libraries.
3D image capabilities	No	Optional conversion from 3D volumetricCBCT data to 2D radiographs.	None - includes interface to 3D imagingsoftware provided with specific systems..Does not view, transfer or process 3Dradiographs.

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Image /page/6/Picture/0 description: The image contains the logo for Henry Schein Infomed Healthcare Software. The logo features the text "HENRY SCHEIN" in a blue font at the top left. Below this text is a red square with a white spine-like design. To the right of the red square is the word "infomed" in a large red font, and below that is the text "Healthcare Software" in a smaller, gray font.

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Image /page/7/Picture/0 description: The image shows the logo for Henry Schein Infomed Healthcare Software. The logo features the text "HENRY SCHEIN" in a blue and black font, with a red square containing a white spine graphic. To the right of the square, the word "infomed" is written in red, with the words "Healthcare Software" in a smaller, gray font below it.

Table 5.1 Summary comparison of characteristics and features – proposed and predicate devices.

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510(k) Premarket Notification – Ortomed

Image /page/8/Picture/1 description: The image contains the logo for Henry Schein Infomed Healthcare Software. The logo features the text "HENRY SCHEIN" in a smaller font above the word "infomed" in a larger, bold, red font. Below "infomed" is the text "Healthcare Software" in a smaller font. To the left of the text is a red square with a white design.

Section 5 – 510(k) Summary

INTENDED USE:

As established in the Indications for Use Statement:

ORTOMED is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthgnathic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.

Ortomed has similar intended uses as the predicate devices and has very similar technological characteristics.

SUMMARY DISCUSSION OF NON-CLINICAL DATA:

The proposed device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA quidance documents:

Guidance for the Submission of Premarket Notifications for Medical Imaging -Management Devices
-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971. Integration, verification and validation testing have been successfully completed following standard ISO 62304.

SUMMARY DISCUSSION OF CLINICAL DATA:

Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.

CONCLUSIONS:

We believe the intended use, the indications for use and performance of the Ortomed software is substantially equivalent to the intended use, indications for use and performance of the predicate device. We also believe that the Ortomed software does not suppose any new or increased risk compared with the predicate device. Based on the information included in this submission, we conclude that Ortomed is substantially equivalent to the listed legally marketed predicate devices.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).