DS Core Diagnosis is a software product for use in dentistry for viewing and interacting with digital or digitized patient media as well as supporting the diagnosis of digital or digitized patient media. Intended users will be able to view and analyze different media types in one viewer.

The Panoramic Curve Proposal feature is intended for patients aged 12 years and older with permanent dentition.

Device Description

DS Core Diagnosis is a cloud-based dental imaging software that provides access to dental media and images via an active internet connection. It is a medical device that can only be used in combination with the DS Core Platform. Classified as a Class II dental imaging software, DS Core Diagnosis allows users to view a variety of media types, including 2D and 3D images (e.g., bitewings, periapicals, panoramic, CBCT, etc.), as well as photos and documentation.

The software includes standard image viewing tools such as annotation, flip, rotate, contrast adjustment, brightness, and magnification.

DS Core Diagnosis also features a Machine Learning enabled panoramic curve proposal algorithm for a proposed panoramic curve of a CBCT scan along the dental arch, which can be adjusted and reviewed by the user. The architecture is a Convolutional Neural Network (CNN) model.

DS Core Diagnosis does not interact directly with patients or control any life-sustaining devices. The software does not perform diagnoses; instead, it provides tools to assist qualified clinicians in interpreting the displayed images and making informed decisions.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for DS Core Diagnosis:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Panoramic Curve Proposal Success Rate (PCPSR): Percentage of cases where the proposed panoramic curve projection layer includes all teeth in the scan.	Dentsply Sirona Scans: PCPSR of 98.81%, with the lower bound of the 95% CI at 94.57%.All Scans (Dentsply Sirona & Third Party): PCPSR of 99%, with 99 of 100 scans considered "successful" and the lower bound of the 95% CI at 95.42%.Various Subgroups: PCPSR range of 97.78-100%, all passing the acceptance criteria.
Clinical Acceptability (Pass/Fail) of Default Panoramic Image: Determine the acceptability of the CBCT reconstructed panoramic images (without user modification) with the panoramic curve proposal generated by the PCP algorithm, to begin working per the standard of care.	Clinical Evaluation Pass Rate: 92.5% pass rate overall for the primary endpoint.
System validation and usability testing for the DS Core Diagnosis device.	All tests successfully passed.

Study Details

Based on the provided text, the following details about the studies can be extracted:

2. Sample size used for the test set and the data provenance:

PCPSR Evaluation:
- Test Set Size (Dentsply Sirona & Third Party): 100 scans (specifically mentioned "99 of 100 scans considered 'successful'").
- Data Provenance: A mix of "Dentsply Sirona Scans" and "Third Party" scans. Specific countries of origin are not detailed, but the inclusion of third-party scans suggests a broader dataset. The text does not explicitly state if it was retrospective or prospective, but given the nature of evaluating existing scans, it's highly likely to be retrospective.
Clinical Evaluation:
- Test Set Size: "a dataset made up of CBCT images". The exact number of cases or images in this dataset is not explicitly stated.
- Data Provenance: Not explicitly stated, but would likely be retrospective CBCT images used for evaluation.

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

PCPSR Evaluation: The text doesn't explicitly state that experts established ground truth for the PCPSR calculation directly. The success rate is described as whether "the proposed panoramic curve projection layer includes all teeth in the scan," which likely refers to an objective assessment based on the image content itself, possibly verified by a technical process rather than subjective expert consensus.
Clinical Evaluation: "clinical experts assessed a dataset". The number of experts is not specified. Their qualifications are described as "clinical experts," implying dental professionals (e.g., dentists, oral and maxillofacial radiologists) but their specific experience levels (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication method for the test set:

The text does not explicitly mention an adjudication method (like 2+1, 3+1). For the clinical evaluation, it states "experts assessed," which could imply independent assessment or consensus, but no specific method is described. For the PCPSR evaluation, the metric seems more objective and less prone to requiring adjudication in the same way.

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 where human readers' performance with and without AI assistance is compared is not explicitly described. The clinical evaluation focuses on the acceptability of the default AI-generated curve, not a comparison of expert performance with and without AI. It emphasizes that users retain full autonomy to adjust the curve.

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

Yes, a standalone performance evaluation was done for the "Panoramic Curve Proposal" feature. The PCPSR evaluation directly assesses the algorithm's ability to propose a curve that includes all teeth, without human intervention in the proposal generation or acceptance. The "clinical evaluation" also assesses the default AI-generated panoramic image "without user modification."

7. The type of ground truth used:

PCPSR Evaluation: The ground truth appears to be an objective determination of whether "all teeth in the scan" are included within the proposed panoramic curve. This would likely be established by a clear definition and potentially manual verification of tooth inclusion. It is closer to expert consensus if human verification was involved, but the description sounds more like an objective technical check.
Clinical Evaluation: The ground truth for this aspect was established by expert consensus/assessment from "clinical experts" on the "clinical acceptability" (pass/fail) of the reconstructed panoramic images.

8. The sample size for the training set:

The document does not provide any information about the sample size used for the training set for the Convolutional Neural Network (CNN) model.

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

The document does not provide any information about how the ground truth for the training set was established. It only describes that the architecture is a Convolutional Neural Network (CNN) model.

Summary

FDA 510(k) Clearance Letter - DS Core Diagnosis

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 12, 2025

Dentsply Sirona Inc.
℅ Deepthi Paknikar
Senior Manager, Regulatory Affairs
221 West Philadelphia St.
Suite 60W
YORK, PA 17401

Re: K250755
Trade/Device Name: DS Core Diagnosis
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QIH
Dated: July 9, 2025
Received: July 9, 2025

Dear Deepthi Paknikar:

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.

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K250755 - Deepthi Paknikar
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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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250755 - Deepthi Paknikar
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assistance/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, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

510(k) Number (if known)
K250755

Device Name
DS Core Diagnosis

Indications for Use (Describe)

Indications for Use

DS Core Diagnosis is a software product for use in dentistry for viewing and interacting with digital or digitized patient media as well as supporting the diagnosis of digital and digitized patient media. Intended users will be able to view and analyze different media types in one viewer.

The Panoramic Curve Proposal feature is intended for patients aged 12 years and older with permanent dentition.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

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510k Summary for DS Core Diagnosis-K250755

K250755_510k Summary
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Prepared: 8/11/2025

Contact Details

Applicant Name: Dentsply Sirona Inc.
Applicant Address: 221 West Philadelphia St. Suite 60W York PA 17401 United States
Applicant Contact Telephone: 630-201-1612
Applicant Contact: Dr. Deepthi Paknikar
Applicant Contact Email: deepthi.paknikar@dentsplysirona.com

Device Name

Device Trade Name: DS Core Diagnosis
Common Name: System, Image Processing, Radiological
Classification Name: Medical image management and processing system
Regulation Number: 892.2050
Product Code(s): QIH

Legally Marketed Predicate Devices

Predicate K#: K132773
Predicate Trade Name: Sidexis 4
Product Code: LLZ

Device Description Summary

The software includes standard image viewing tools such as annotation, flip, rotate, contrast adjustment, brightness, and magnification.

Intended Use/Indications for Use

The Panoramic Curve Proposal feature is intended for patients aged 12 years and older with permanent dentition.

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K250755_510k Summary
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Indications for Use Comparison

Both the subject and predicate devices share the same essential indications for use. While there are minor distinctions—such as the subject device's absence of image acquisition and its cloud-based functionality— these differences do not affect the safety and effectiveness of the device. Both devices ultimately serve the same core purpose: to provide a platform for image review and diagnosis by qualified professionals.

Technological Comparison

Both devices are software as a medical device and allow users to view a variety of media types, including 2D and 3D images. The subject device is a cloud-based software as a medical device, whereas the predicate device is a downloaded desktop-based software as a medical device. The subject device does not include image acquisition, whereas the predicate device does. Both devices offer the same fundamental user-defined settings for image viewing, such as brightness, contrast, zoom, gamma, moving content in the media window, and image navigation. Minor differences in the viewer exist, such as the organization of the viewing windows or the appearance of feature (brightness, contrast, etc.) icons. Both devices include a panoramic curve proposal feature that can be manually reviewed and adjusted by the user. The panoramic curve proposal feature is AI/ML enabled in the subject device and is not AI/ML enabled for the predicate device.

Non-Clinical Tests Summary & Conclusions

Nonclinical performance testing results were reviewed as part of this submission. Software verification and validation testing was also completed.

For model-specific performance evaluation, the panoramic curve proposal success rate (PCPSR) was measured. The PCPSR represents the percentage of cases where the proposed panoramic curve projection layer includes all teeth in the scan. The evaluation results showed that the panoramic curve proposal performance met the prespecified acceptance criteria.

Dentsply Sirona Scans: PCPSR of 98.81%, with the lower bound of the 95% CI at 94.57%.

All Scans (Dentsply Sirona & Third Party): PCPSR of 99%, with 99 of 100 scans considered "successful" and the lower bound of the 95% CI at 95.42%. Various subgroups were analyzed, yielding a PCPSR range of 97.78-100%, all passing the acceptance criteria.

An expert clinical evaluation was also conducted that passed all predefined acceptance criteria. In this evaluation, clinical experts assessed a dataset made up of CBCT images, to evaluate the reconstructed CBCT panorama to determine the clinical acceptability of the default panoramic image (without user modification) with the panoramic curve proposal generated by the Panoramic Curve Proposal (PCP) algorithm. The results demonstrated that the predefined primary endpoint acceptance criteria were met, which was to determine the acceptability (pass/fail) of the CBCT reconstructed panoramic images based on the panoramic curve proposal (without user modification) to begin working per the standard of care. The results reported a 92.5% pass rate overall for the primary endpoint of this evaluation, demonstrating that the expert clinical evaluation was successful for the panoramic curve proposal algorithm.

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K250755_510k Summary
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System validation and usability testing for the DS Core Diagnosis device were conducted with clinicians, including the panoramic curve proposal feature in the scope. The results demonstrated that all tests were successfully passed.

In summary, the panoramic curve proposal feature performance met the prespecified acceptance criteria, with a very high success rate and highly generalizable performance across different subgroups. Regardless of this strong performance, the users of the device retain full autonomy and can adjust and review the proposed panoramic curve.

The results of nonclinical performance testing support the determination of substantial equivalence.

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).