RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.

Device Description

RTapp™ v2.0 is a stand-alone software medical device. RTapp analyzes and visualizes the day-to-day variations in a radiation therapy patient's individual anatomical structures and the effect of those changes on the treatment dose; it is an aid during use by radiation oncology.
The RTapp software:

Automatically queries and retrieves treatment plan data and images from any DICOM compliant equipment.
Automatically processes all patient's treatment fractions, flagging and presenting an advance warning of treatment plans at risk with an email notification.
Monitors and evaluates treatment plan performance in real time by using the Plan Performance Dose Volume Histogram (DVH). The DVH projects the amount of dose to be delivered.
Displays Deformable Image Registration contours, cross correlation metrics and flagging of large deformations.
Projects when Organs At Risk will exceed dose constraints.
Dose estimation
Generates reports as PDF with images and graphs.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the U.S. FDA for the RTapp™ v2.0 device. This document details the device's indications for use, its comparison to a predicate device, and the general software verification and validation testing performed. However, it does not contain specific acceptance criteria tables or detailed study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance data, or detailed ground truth methodologies) that would typically be associated with a comprehensive study proving a device meets specific performance criteria.

The document states:

"Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The RTapp software is considered a "Major" level of concern."
"Non-clinical, verification and validation (V&V) performance testing was conducted on anonymized, retrospective, clinically-relevant data using computer systems for single and multi-users that met minimum configuration specifications in order to test the device design requirements and user needs."
"RTapp™ v2.0, which includes some off-the-shelf software, underwent V&V testing and regression analysis of manual test suites interfacing with external DICOM servers."
"The following features for comparing DICOM-compliant images were tested: automated and manual workflows, image visualization, alignment, settings for configuring the dashboard and visual displays, user interface, importing and exporting DICOM data, processing and loading time, dose volume histogram graphs, and reports."
"All test protocols passed, and acceptance criteria were met indicating successful verification and validation of the subject device and substantial equivalence to the predicate device."

This information confirms that V&V testing was performed and acceptance criteria were met, but the specific details of these criteria and the associated study data are not provided in this summary document. The document focuses on demonstrating substantial equivalence to a predicate device (RTapp™ v1.0) rather than presenting a detailed clinical performance study with the metrics you've requested.

Therefore,Based on the provided FDA 510(k) summary for RTapp™ v2.0, the document does not contain the detailed information necessary to fully answer your request regarding specific acceptance criteria metrics, study sample sizes, expert qualifications, or detailed ground truth methodologies.

The document states that "All test protocols passed, and acceptance criteria were met indicating successful verification and validation of the subject device and substantial equivalence to the predicate device." However, it does not disclose the specific numerical acceptance criteria or the raw performance data against those criteria.

Here's what can be inferred or stated based on the provided text, and what information is missing:

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

Acceptance Criteria: Not explicitly stated in numerical form. The document generally refers to successful verification and validation of device features related to image comparison, registration, display, workflow, data handling, and reporting.
Reported Device Performance: Not numerically reported. The document only states that "All test protocols passed, and acceptance criteria were met."

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

Sample Size: Not specified.
Data Provenance: "Anonymized, retrospective, clinically-relevant data." The country of origin is not specified.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
The document implies that the ground truth for evaluating features like deformable image registration accuracy or dose estimation would rely on established radiation oncology principles and possibly comparison to the predicate device's known performance.

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

Not specified.

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:

Answer: No, an MRMC comparative effectiveness study is not mentioned. The device, RTapp™ v2.0, is described as an "aid" for radiation oncology professionals and is not a diagnostic AI intended to replace or significantly augment human perception in a way that typically warrants an MRMC study for improved reader performance. Its function is comparison of DICOM-compliant imaging data, registration, and display, with features like flagging at-risk plans and projecting dose constraints. The focus is on functionality and substantial equivalence to a predicate, not on improving human reader diagnostic accuracy.

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

Answer: Yes, or at least implied. The V&V testing likely included automated tests of the software's functionality and accuracy in its core tasks (e.g., image registration, dose volume histogram generation, data import/export), indicating standalone performance assessment. The device is a "stand-alone software."

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

"Clinically-relevant data" implies that the ground truth would be based on established clinical benchmarks or calculations for image registration, dose distribution, and other parameters that RTapp™ v2.0 processes. It's not explicitly stated if this involved new expert consensus readings or if it relied on the inherent properties of the DICOM data as processed by accepted clinical standards. Given it's an "aid" for comparison of imaging data for radiation oncology, the ground truth would likely relate to the accuracy of its data analysis and visualization capabilities compared to expected clinical outcomes or calculations.

8. The sample size for the training set:

Not specified. The document refers to V&V testing on "anonymized, retrospective, clinically-relevant data" for the test set. It does not explicitly mention a separate "training set" or how a machine learning model, if any, was trained, as the device's core technology is described as "Deformable Image Registration using an "Optical-Flow" algorithm."

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

Not specified. (See point 8).

In summary, this 510(k) notification confirms that the required software verification and validation testing was performed and met acceptance criteria, demonstrating substantial equivalence to the predicate. However, it does not provide the detailed study specifics or quantitative performance metrics typically found in a clinical performance study summary.

Summary

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SegAna, Inc. % Ms. Jennifer Bosley, Sr. Director of Quality & Regulatory Affairs 3259 Progress Drive ORLANDO FL 32826

Re: K212887

Trade/Device Name: RTapp™ v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 8, 2021 Received: September 10, 2021

Dear Ms. Bosley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212887

Device Name

RTapp™ v2.0

Indications for Use (Describe)

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

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510(k) Summary

I. SUBMITTER

SegAna. Inc. 3259 Progress Drive Orlando, FL 32826 USA

Telephone: 866-347-0898 Contact Person: Jennifer Bosley, MBA, RAC Date Prepared: November 9, 2021

II. DEVICE

510(k) Number:	K212887
Name of Device:	RTapp™ v2.0
Common/Usual Name:	Image Processing Aid to Radiation Therapy Treatment Planning
Classification Name:	Medical Image Management and Processing System
Regulation Number:	21 CFR §892.2050
Regulatory Class:	II
Product Code:	LLZ - System, Image Processing, Radiological

III. PREDICATE DEVICE

RTapp™ v1.0 (K191610, SegAna, Inc.) This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The RTapp software:

Automatically queries and retrieves treatment plan data and images from any DICOM compliant equipment.
Automatically processes all patient's treatment fractions, flagging and presenting ● an advance warning of treatment plans at risk with an email notification.
Monitors and evaluates treatment plan performance in real time by using the Plan ● Performance Dose Volume Histogram (DVH). The DVH projects the amount of dose to be delivered.

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. Displays Deformable Image Registration contours, cross correlation metrics and flagging of large deformations.
Projects when Organs At Risk will exceed dose constraints.
. Dose estimation
Generates reports as PDF with images and graphs.

RTapp is intended for use by radiation oncology professionals in a hospital/clinical setting for any patient undergoing radiation therapy based on a treatment plan. RTapp is NOT intended as a treatment planning software and cannot be used to generate radiotherapy treatment plans.

V. INDICATIONS FOR USE

The Indications For Use statement for RTapp™ v2.0 is identical to the predicate device. Both the subject and predicate devices have the same intended use and indications for use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the subject device and the predicate device are the same, Deformable Image Registration using an "Optical-Flow" algorithm for the comparison of DICOM-compliant imaging data as an aid in radiation oncology. The following difference exists between the subject and predicate device:

. Predicate device only imports data for comparison, while the subject device can import and export data.

VII. PERFORMANCE DATA

Performance data was provided in support of the substantial equivalence determination.

Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The RTapp software is considered a "Major" level of concern.

Non-clinical, verification and validation (V&V) performance testing was conducted on anonymized, retrospective, clinically-relevant data using computer systems for single and multi-users that met minimum configuration specifications in order to test the device design requirements and user needs. RTapp™ v2.0, which includes some offthe-shelf software, underwent V&V testing and regression analysis of manual test

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suites interfacing with external DICOM servers. The following features for comparing DICOM-compliant images were tested: automated and manual workflows, image visualization, alignment, settings for configuring the dashboard and visual displays, user interface, importing and exporting DICOM data, processing and loading time, dose volume histogram graphs, and reports. All test protocols passed, and acceptance criteria were met indicating successful verification and validation of the subject device and substantial equivalence to the predicate device.

VIII. CONCLUSION

Non-clinical performance data show the RTapp™ v2.0 is substantially equivalent to the predicate device. The software verification and validation demonstrate that the RTapp™ v2.0 device should perform as intended in the specified use conditions.

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).