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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the CEPHX - Cephalometric Analysis Software, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the primary endpoint, the acceptance criterion was at least 85% of cases meeting the "pass" criteria. A "pass" was defined as 21 clinically significant landmarks detected automatically by the AI algorithm being within 2.0mm of the manually detected landmarks.

Acceptance Criteria	Reported Device Performance
At least 85% of cases meeting "pass"	99% of landmarks were identified, meeting the study endpoint.
"Pass" defined as ≤ 2.0mm margin for landmarks	99% of landmarks met the ≤ 2.0mm margin.

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

Test Set Sample Size: The exact number of cases (images) in the test set is not explicitly stated. However, it mentions the comparison of AI-generated landmarks with manually detected landmarks across "21 clinically significant landmarks" per case. To determine "99% of landmarks were identified," a sufficient number of images would have been used.
Data Provenance: Not explicitly stated in the document whether the data was retrospective or prospective, or its country of origin.

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

Number of Experts: Three (3)
Qualifications: "Three experienced orthodontic specialists." Specific years of experience are not mentioned.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

The document states "compared to three experienced orthodontic specialists." This implies that the AI's performance was compared against the consensus or individual assessments of these three specialists. It doesn't detail a specific adjudication method like 2+1 or 3+1 (where differences are resolved by an additional reader). It simply states the AI's results were compared to the specialists' results. Given the wording, it's most likely that the ground truth was established by comparing the AI's output against the collective or individual manual markings of all three. If a strict consensus was used, it's not explicitly 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

No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not conducted or reported. The study focused solely on the standalone performance of the AI algorithm against human-established ground truth.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was Done

Yes, a standalone performance study was done. The document explicitly states: "The device's stand-alone performance was established against the ground truth..."

7. The Type of Ground Truth Used

The ground truth used was expert consensus / manual annotation. Specifically, it was established by "manually generated landmarks by orthodontic specialists." The AI's performance was then compared to these manually detected landmarks.

8. The Sample Size for the Training Set

The sample size for the training set is not mentioned in the provided document. The performance data section only discusses the verification study (testing).

9. How the Ground Truth for the Training Set Was Established

Information on how the ground truth for the training set was established is not provided in this document. The document only details the ground truth methodology for the test set.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K231396

Device Name CEPHX - Cephalometric Analysis Software

Indications for Use (Describe)

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

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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

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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

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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

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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

Parameter	CEPHX	WebCeph K220903	Comparison
Indication for Use	CEPHX - Cephalometric AnalysisSoftware is a software indicatedfor use by dentists who provideorthodontic treatment for imageanalysis, simulation, profilogram,VTO (Visual Treatment Objective)	WebCeph is a softwareindicated for use by dentistswho provide orthodontictreatment for image analysis,simulation, profilogram,VTO/STO (Visual Treatment	Different -Has no safety orsecurity impact onthe product. TheSTO and age
Parameter	CEPHX	WebCeph K220903	Comparison
	and patient consultation. Resultsproduced by the software'sdiagnostic, treatment planningand simulation tools aredependent on the interpretationof trained and licensedpractitioners or dentists. Thedevice is only for use on patients14 years old and above.	Objective) and patientconsultation. Results producedby the software's diagnostic,treatment planning andsimulation tools are dependenton the interpretation of trainedand licensed practitioners ordentists. The device is only forthe use of patients above 7years old.	differences aredetailed below.
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network	Same
Operating System	Microsoft Window 7, 8, 10	Microsoft Window 7, 8, 10	Same
User Interface	Mouse, Keyboard	Mouse, Keyboard	Same
CPU processor type	x64-based processor or higher	x64-based processor or higher	Same
Image Communication Standard	BMP, JPG, PNG	BMP, JPG, PNG	Same
Modality Support	X-ray or CT	X-ray or CT	Same
Component	Client (Internet Browser)	Client (Internet Browser)	Same
DatabaseCompatibility	MySQL	PostgreSQL	Different -Has no safety,security orperformanceimpact on theproduct. Thedifference isexplained anddetailed below.
Image Measurementtools	Linear distance, angle	Linear distance, angle	Same
Image viewing	Full, side by side, thumbnail,Zoom in / out, template.	Full, side by side, thumbnail,Zoom in / out, template.	Same
Image manipulation	Brightness, contrast, flip, rotate,annotation, cephalometrictracing.	Brightness, contrast, flip, rotate,annotation, cephalometrictracing.	Same
Parameter	CEPHX	WebCeph K220903	Comparison
Cephalometrictracing	In addition to the user-configuredanalysis, standard orthodontictracing analysis include: Downs,Steiner, Jarabek, McNamara,Ricketts, Eastman, Kim, Wits.	In addition to the user-configured analysis, standardorthodontic tracing analysisinclude: Downs, Steiner,Jarabek, McNamara, Ricketts,Eastman, Kim, Wits.	Same
Implant module	None	None	Same
3D imaging capability	None	None	Same
Image annotation	Paint, draw, magnify, linedrawing, distance measure (px ormm), 3-point angle,ruler(calibrate), select regioncrop.	Paint, draw, magnify, linedrawing, distance measure (pxor mm), 3-point angle,ruler(calibrate), select regioncrop.	Same
Treatment Planning,Simulation and follow up	-Translate, tip and rotate incisors,reposition molars, rotatemandible and skeletal structures -Superimpose one or more growthtracings over original tracing.	-Translate, tip and rotateincisors, reposition molars,rotate mandible - Superimposeone or more growth tracingsover original tracing.	Different -Has no safety orsecurity impact onthe product. TheSkeletal structuredifference isexplained anddetailed below.
Supported Area	Dental, Maxilla, Mandible	Dental, Maxilla, Mandible	Same

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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

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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

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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.

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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.

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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.

Regulation Number and Section

N/A