K Number
K231396
Device Name
CEPHX- Cephalometric Analysis Software
Manufacturer
Date Cleared
2024-01-31

(261 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CEPHX - Cephalometric Analysis Software is indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. Results produced by the software's diagnosic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for use on patients 14 years old and above.
Device Description
CEPHX – Cephalometric Analysis Software uses cephalometric x-ray images to help dentists study the relationships between bone and soft tissue landmarks and can be used to diagnose facial abnormalities throughout an orthodontic treatment. As a first step, the user uploads a 2D cephalometric image and the software generates 99 cephalometric landmark points. The landmarks are important points in a lateral radiographic view of the teeth, jaws and base of the skull, and are used in multiple cephalometric analyses, which have proven to be a useful aid in basic orthodontic differential diagnosis. Once the landmark points are created, the user can generate a full report by choosing from a large selection of built-in analysis methods or create a customed analysis using the Analysis Wizard. The report can be printed or downloaded according to the user selection.
More Information

Not Found

Yes
The summary explicitly mentions "Artificial-Intelligence (AI) computer generated landmarks" and "Al-based cephalometric analysis software" and describes a study verifying the accuracy of the AI-generated landmarks.

No
The device is a software for image analysis and simulation to aid in diagnosis and treatment planning by dentists, not a device that directly administers therapy or performs a therapeutic function.

Yes

Explanation: The "Intended Use / Indications for Use" section states that the software is for "diagnostic, treatment planning and simulation tools". Additionally, the "Device Description" explicitly mentions that it "can be used to diagnose facial abnormalities throughout an orthodontic treatment."

Yes

The device description explicitly states "CEPHX – Cephalometric Analysis Software" and details its function as software processing uploaded images. There is no mention of accompanying hardware components required for its primary function.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • CEPHX Function: CEPHX analyzes images (cephalometric x-rays) of the patient's anatomy. It does not perform tests on biological samples.
  • Intended Use: The intended use is for image analysis, simulation, and treatment planning based on these images, not for analyzing biological samples.

Therefore, CEPHX falls under the category of medical image analysis software rather than an In Vitro Diagnostic device.

No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked as "Not Found."

Intended Use / Indications for Use

CEPHX - Cephalometric Analysis Software is indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. Results produced by the software's diagnosic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for use on patients 14 years old and above.

Product codes

QIH

Device Description

CEPHX – Cephalometric Analysis Software uses cephalometric x-ray images to help dentists study the relationships between bone and soft tissue landmarks and can be used to diagnose facial abnormalities throughout an orthodontic treatment.

As a first step, the user uploads a 2D cephalometric image and the software generates 99 cephalometric landmark points. The landmarks are important points in a lateral radiographic view of the teeth, jaws and base of the skull, and are used in multiple cephalometric analyses, which have proven to be a useful aid in basic orthodontic differential diagnosis. Once the landmark points are created, the user can generate a full report by choosing from a large selection of built-in analysis methods or create a customed analysis using the Analysis Wizard. The report can be printed or downloaded according to the user selection.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

X-ray or CT

Anatomical Site

Dental, Maxilla, Mandible

Indicated Patient Age Range

14 years old and above.

Intended User / Care Setting

dentists who provide orthodontic treatment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A study for Verification of Artificial-Intelligence (AI) computer generated landmarks in cephalometric tracing versus manual landmarks provided by orthodontic specialists was conducted. In general, The study aimed to verify the accuracy of Al-generated landmarks in cephalometric tracing compared to manually generated landmarks by orthodontic specialists. CephX, the Al-based cephalometric analysis software, was evaluated for its reliability and precision in detecting critical cephalometric landmarks compared to three experienced orthodontic specialists. The study design involved the comparison of 21 clinically significant landmarks detected automatically by the Al algorithm to the manually detected landmarks by the three orthodontic specialists, with a margin of up to 2.0mm considered "pass" and a margin above this range considered "fail".

The results showed that 99% of landmarks were identified, meeting the study endpoint and predefined hypothesis. The secondary endpoints also showed very good accuracy without any outliers. The device's stand-alone performance was established against the ground truth, and the acceptance criteria of at least 85% of cases meeting the "pass" criteria were satisfied.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K220903

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

January 31, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Orca Dental AI LTD % Daniel Abraham CEO 10 Hamanofim Street HERZLIYA, PO 4672561 ISRAEL

Re: K231396

Trade/Device Name: CEPHX- Cephalometric Analysis Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: January 4, 2024 Received: January 5, 2024

Dear Daniel Abraham:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K231396

Device Name CEPHX - Cephalometric Analysis Software

Indications for Use (Describe)

CEPHX - Cephalometric Analysis Software is indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. Results produced by the software's diagnosic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for use on patients 14 years old and above.

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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3

Image /page/3/Picture/0 description: The image shows the logo for CEPHX by Orca Dental AI. The word "CEPHX" is written in large, blue, sans-serif font. The "X" in CEPHX is stylized with a blue curve on the left and a black curve on the right. Below the word "CEPHX" is the phrase "BY ORCA DENTAL AI" in a smaller, sans-serif font.

Document name: 510(k) Summary CEPHX - Cephalometric Analysis Software

Page 3 of 9

K231396

1. SUBMITTER NAME AND ADDRESS:

Orca Dental Al Ltd. 10 Hamanofim street, Herzliya, PO 4672561, Israel

2. CONTACT DETAILS

a. Primary contact person details: Name: Daniel Abraham

Title: CEO

Email: danny@orca-dental.ai

Phone Number: +972 52 333 3776

Office: +972 52 333 3776

b. Secondary contact person details: Name: Chen Porat

Title: VP Sales & Marketing

Email: chen@cephx.com

Phone Number: +972 543129939

Office: +972 543129939

    1. DEVICE DETAILS:

Device Trade Name (proprietary name):

CEPHX – Cephalometric Analysis Software

Device Common Name:

Medical Imaging Software

Product Classification:

  • Name: Medical image management and processing system ●
  • . Product code: QIH

4

Image /page/4/Picture/0 description: The image shows the logo for CEPHX by Orca Dental AI. The word "CEPHX" is written in large, blue, sans-serif font. Below the word "CEPHX" is the phrase "BY ORCA DENTAL AI" in a smaller, sans-serif font. The last letter of CEPHX is stylized with a black curve on the right side.

Document name: 510(k) Summary CEPHX - Cephalometric Analysis Software

Page 4 of 9

  • Regulation No: 892.2050
  • Class: II
  • Panel: Radiology
    1. PREDICATE DEVICE(S):

Device Trade Name (proprietary name):

WebCeph

Clearence No .:

K220903

Device Common Name:

Medical Imaging Software

Product Classification:

  • Name: Medical image management and processing system
  • Product code: LLZ
  • Regulation No: 892.2050
  • Class: II

Panel: Radiology

5. DEVICE DESCRIPTION

CEPHX – Cephalometric Analysis Software uses cephalometric x-ray images to help dentists study the relationships between bone and soft tissue landmarks and can be used to diagnose facial abnormalities throughout an orthodontic treatment.

As a first step, the user uploads a 2D cephalometric image and the software generates 99 cephalometric landmark points. The landmarks are important points in a lateral radiographic view of the teeth, jaws and base of the skull, and are used in multiple cephalometric analyses, which have proven to be a useful aid in basic orthodontic differential diagnosis. Once the landmark points are created, the user can generate a full

5

Image /page/5/Picture/0 description: The image shows the header of a document. The header includes the logo for CEPHX by Orca Dental AI, the document name, the date issued, and the page number. The document name is "510(k) Summary CEPHX - Cephalometric Analysis Software", the date issued is "28/01/2024", and the page number is "5 of 9".

report by choosing from a large selection of built-in analysis methods or create a customed analysis using the Analysis Wizard. The report can be printed or downloaded according to the user selection.

INDICATIONS FOR USE & INTENDED USE: 6.

CEPHX - Cephalometric Analysis Software is indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for use on patients 14 years and above.

Patient population:

Patients 14 years old and above.

Intended users:

The software is to be used by qualified dentists.

Before any use of the software, the user has to be trained on proper and safe use of the software.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

ParameterCEPHXWebCeph K220903Comparison
Indication for UseCEPHX - Cephalometric Analysis
Software is a software indicated
for use by dentists who provide
orthodontic treatment for image
analysis, simulation, profilogram,
VTO (Visual Treatment Objective)WebCeph is a software
indicated for use by dentists
who provide orthodontic
treatment for image analysis,
simulation, profilogram,
VTO/STO (Visual TreatmentDifferent -
Has no safety or
security impact on
the product. The
STO and age
ParameterCEPHXWebCeph K220903Comparison
and patient consultation. Results
produced by the software's
diagnostic, treatment planning
and simulation tools are
dependent on the interpretation
of trained and licensed
practitioners or dentists. The
device is only for use on patients
14 years old and above.Objective) and patient
consultation. Results produced
by the software's diagnostic,
treatment planning and
simulation tools are dependent
on the interpretation of trained
and licensed practitioners or
dentists. The device is only for
the use of patients above 7
years old.differences are
detailed below.
PlatformIBM-compatible PC or PC networkIBM-compatible PC or PC networkSame
Operating SystemMicrosoft Window 7, 8, 10Microsoft Window 7, 8, 10Same
User InterfaceMouse, KeyboardMouse, KeyboardSame
CPU processor typex64-based processor or higherx64-based processor or higherSame
Image Communication StandardBMP, JPG, PNGBMP, JPG, PNGSame
Modality SupportX-ray or CTX-ray or CTSame
ComponentClient (Internet Browser)Client (Internet Browser)Same
Database
CompatibilityMySQLPostgreSQLDifferent -
Has no safety,
security or
performance
impact on the
product. The
difference is
explained and
detailed below.
Image Measurement
toolsLinear distance, angleLinear distance, angleSame
Image viewingFull, side by side, thumbnail,
Zoom in / out, template.Full, side by side, thumbnail,
Zoom in / out, template.Same
Image manipulationBrightness, contrast, flip, rotate,
annotation, cephalometric
tracing.Brightness, contrast, flip, rotate,
annotation, cephalometric
tracing.Same
ParameterCEPHXWebCeph K220903Comparison
Cephalometric
tracingIn addition to the user-configured
analysis, standard orthodontic
tracing analysis include: Downs,
Steiner, Jarabek, McNamara,
Ricketts, Eastman, Kim, Wits.In addition to the user-
configured analysis, standard
orthodontic tracing analysis
include: Downs, Steiner,
Jarabek, McNamara, Ricketts,
Eastman, Kim, Wits.Same
Implant moduleNoneNoneSame
3D imaging capabilityNoneNoneSame
Image annotationPaint, draw, magnify, line
drawing, distance measure (px or
mm), 3-point angle,
ruler(calibrate), select region
crop.Paint, draw, magnify, line
drawing, distance measure (px
or mm), 3-point angle,
ruler(calibrate), select region
crop.Same
Treatment Planning,
Simulation and follow up-Translate, tip and rotate incisors,
reposition molars, rotate
mandible and skeletal structures -
Superimpose one or more growth
tracings over original tracing.-Translate, tip and rotate
incisors, reposition molars,
rotate mandible - Superimpose
one or more growth tracings
over original tracing.Different -
Has no safety or
security impact on
the product. The
Skeletal structure
difference is
explained and
detailed below.
Supported AreaDental, Maxilla, MandibleDental, Maxilla, MandibleSame

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Image /page/6/Picture/0 description: The image shows the logo for CEPHX by Orca Dental AI. The word "CEPHX" is written in blue, with the "X" stylized with a blue and black design. Below the word "CEPHX" is the text "BY ORCA DENTAL AI".

Document name: 510(k) Summary CEPHX - Cephalometric Analysis Software

Page 6 of 9

7

Image /page/7/Picture/0 description: The image shows the logo for CEPHX by Orca Dental AI. The word "CEPHX" is written in a large, sans-serif font in blue. Below the word "CEPHX" is the phrase "BY ORCA DENTAL AI" in a smaller, sans-serif font. The "X" in CEPHX is stylized with a black curve on the right side.

Document name: 510(k) Summary CEPHX - Cephalometric Analysis Software

Page 7 of 9

8. INDICATION FOR USE COMPARISON:

The subject device doesn't have the STO (Surgical Treatment Objective) - this is a feature to outline soft tissues. Note having this feature doesn't impact the product safety, security or performance. In addition, the phrase "the use of" was changed to "use on" to make it clearer that it is referring to the target patient population. Lastly, the predicate device is intended for use in patients aged 7 and up, while the subject device is intended for use in patients aged 14 and up. This difference does not raise any new questions of safety and effectiveness since we are just excluding the age group we do not have clinical data at this time.

8

Image /page/8/Picture/0 description: The image shows the logo for CEPHX by Orca Dental AI. Below the logo is the document name, which is "510(k) Summary CEPHX - Cephalometric Analysis Software". The image also shows the date issued, which is 28/01/2024, and the page number, which is page 8 of 9.

9. Technological Characteristics

CEPHX - Cephalometric Analysis Software is a software that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software's diagnostic, treatment planning tools are dependent on the interpretation of trained and licensed practitioners or dentists.

The software is a supporting tool, providing recommendation for tracing landmarks on Ceph images, but not replacing the action performed by the clinician.

The technological characteristics are as described in the table above.

10. Performance Data

A study for Verification of Artificial-Intelligence (AI) computer generated landmarks in cephalometric tracing versus manual landmarks provided by orthodontic specialists was conducted. In general, The study aimed to verify the accuracy of Al-generated landmarks in cephalometric tracing compared to manually generated landmarks by orthodontic specialists. CephX, the Al-based cephalometric analysis software, was evaluated for its reliability and precision in detecting critical cephalometric landmarks compared to three experienced orthodontic specialists. The study design involved the comparison of 21 clinically significant landmarks detected automatically by the Al algorithm to the manually detected landmarks by the three orthodontic specialists, with a margin of up to 2.0mm considered "pass" and a margin above this range considered "fail".

The results showed that 99% of landmarks were identified, meeting the study endpoint and predefined hypothesis. The secondary endpoints also showed very good accuracy without any outliers. The device's stand-alone performance was established against the ground truth, and the acceptance criteria of at least 85% of cases meeting the "pass" criteria were satisfied.

9

Image /page/9/Picture/0 description: The image shows the header and footer of a document. The header contains the logo for CEPHX by ORCA Dental AI. The document name is "510(k) Summary CEPHX - Cephalometric Analysis Software". The footer contains the page number, which is page 9 of 9, and the date issued, which is 28/01/2024.

11. Conclusions

The CEPHX - Cephalometric Analysis Software and the predicate device have similar intended use, indication for use, technological features and performance characteristics.

Performance and software validation data demonstrate that the differences between the CEPHX - Cephalometric Analysis Software and the predicate do not raise any new questions of safety and effectiveness.