Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used radiation oncology personnel for quality assurance purposes.

Device Description

Delta4 Insight is software specifically design for quality assurance of radiotherapy treatment plans generated by a treatment planning system. The device calculates a secondary dose calculation via an independent Monte-Carlo based dose calculation software and compares this to the treatment planning system dose. The device is used as a secondary check for the results of a TPS and not for comparison with a measurement.

Delta4 Insight is a software module within the General Delta4 software. The software module is independent of all other software modules within the Delta4 software. The device is NOT a treatment planning system or a radiation therapy delivery device. It is only used by trained radiation therapy oncology personnel for the purposes of quality assurance in a hospital setting.

Insight supports treatments with MV photons. No other radiation type is supported.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Delta4 Insight device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Used by Predicate)	Reported Delta4 Insight Performance
97% of dose voxels with >5% of maximum dose pass a gamma criteria of 2%/2mm when comparing patient plan dose calculation results to a reference algorithm (Acuros). [Hoffman et al, MedPhys 2018]	Similar gamma pass rate to that of the predicate when comparing patient plan dose calculation results to a reference algorithm (Monaco, Acuros).

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

Sample Size: "Test plans were chosen to span the space of test parameters for the types of treatment types/modalities/energies/TPS/machines that are supported. The variety of plans tested are reflective of common clinical treatments and tumor sites and span many field sizes and tissue depths."
- Interpretation/Clarification: The exact number of test plans used is not specified. However, the description implies a diverse set of clinically relevant plans.
Data Provenance: "The dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared."
- Interpretation/Clarification: The data consists of retrospective, anonymized DICOM patient treatment plans. The country of origin is not specified but is likely from European or North American oncology departments given the context of FDA submission and common practices.

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

The document does not explicitly state that human experts established a "ground truth" for the test set in the traditional sense of clinical assessment.
Instead, the comparison is made against "reference algorithms" (Acuros, Monaco) which themselves are established dose calculation engines. The accuracy of these reference algorithms is implicit, and one (Acuros) is cited with a publication (Hoffman et al, MedPhys 2018).
The study focuses on the agreement between software calculations, not expert visual assessment.

4. Adjudication Method for the Test Set

The concept of "adjudication" (e.g., 2+1, 3+1 expert review) is not applicable to this type of study.
The comparison method used is a gamma comparison between the Delta4 Insight dose results and the original reference TPS dose. Gamma analysis is a common method in radiation oncology for quantitatively comparing dose distributions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done.
This device is a "secondary check QA software" designed for an algorithm-to-algorithm comparison (Delta4 Insight's calculation vs. Treatment Planning System's calculation), not for human reader performance evaluation. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not relevant to this submission.

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

Yes, a standalone performance evaluation was indeed done.
The study explicitly describes comparing "the dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared." This is a direct measure of the algorithm's performance in matching established reference calculations.

7. The Type of Ground Truth Used

The "ground truth" in this context is the dose calculation results from established "reference algorithms" (Monaco, Acuros) within existing Treatment Planning Systems (TPS). It is not pathology, outcomes data, or human expert consensus in the diagnostic imaging sense. It is a comparison against other validated computational models for dose calculation.

8. The Sample Size for the Training Set

The document does not specify a separate training set size.
The description focuses on "validation testing involved testing of clinical treatment plans" and "test plans were chosen to span the space of test parameters." This suggests that the device's algorithms were likely developed and refined using internal data, but the 510(k) summary only describes the validation/test set and its performance.

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

Since a training set is not explicitly mentioned with its own ground truth establishment in this document, this information is not provided.
Typically, for a dose calculation algorithm, "ground truth" during development (training) would involve comparing the algorithm's output against physical measurements (e.g., phantom measurements, ionization chamber data) and/or highly accurate, gold-standard Monte Carlo simulations for a variety of beam configurations and patient geometries. However, this 510(k) summary focuses on the comparative performance against other clinical TPS algorithms for validation.

Summary

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January 16, 2024

Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

ScandiDos AB % Daniel Pederson QA & RA Manager Dag Hammarskjölds väg 52A Uppsala, Uppland 752 37 SWEDEN

Re: K223234

Trade/Device Name: Delta4 Insight Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: December 1, 2023 Received: December 12, 2023

Dear Daniel Pederson:

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 (OS) 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 (OS) 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 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,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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) K223234

Device Name Delta4 Insight

Indications for Use (Describe)

Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment dose calculation.

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

1 APPLICANT

510(k) owner's Name	ScandiDos AB
Street address	Dag Hammarskjölds väg 52A
Postal Code, City	SE-75237 Uppsala
Country	Sweden
Phone Number (mobile)	+46-73-502 81 50
Fax Number	+46-18-10 74 02
Name of official correspondent	Daniel Pederson
Date the summarywas prepared (yyyy-mm-dd)	2023-12-01

ମ DEVICE

Trade Name	Delta4 Insight
Common/Usual Name	Secondary Check QA Software
Device Classification Name	Medical charged-particle radiation therapy system(§892.5050)
Product code	IYE

3 PREDICATE DEVICES/

Predicate Devices	RegisteredEstablishment Number	510(k) Premarket submissionnumber
SciMoCa	3009140718	K180595

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4 DESCRIPTION OF THE DEVICE

Insight supports treatments with MV photons. No other radiation type is supported.

5 INTENDED USE OF THE DEVICE

Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment plans by an independent dose calculation.

Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used only by trained radiation oncology personnel for quality assurance purposes.

The intended use of the new device is contained within the intended use of the predicate device.

6 SAFETY AND ESSENTIAL PERFORMANCE

The following standards apply to the device (general use): IEC 62304:2006/A1:2016

7 PERFORMANCE DATA

The following performance data were provided in support of substantial equivalence:

Software verification and validation testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Validation testing involved testing of clinical treatment plans and simulated clinical workflows and environment. Verification tests were performed to verify the product performed to specification and functions as it was designed. These tests include tests to verify requirements for functionality, accuracy,

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compatibility, tests to ensure risk mitigations function as intended, and regression tests to ensure the safety and effectiveness of functionality.

Test plans

Non-clinical testing was conducted in accordance with the FDA guidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]." The dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared. Test plans were chosen to span the space of test parameters for the types of treatment types/modalities/energies/TPS/machines that are supported. The variety of plans tested are reflective of common clinical treatments and turnor sites and span many field sizes and tissue depths. The results were analyzed using a gamma comparison between Insight dose results and the original reference TPS dose.

Summary

The device passed verification and validation testing and was deemed safe and effective for its intended use. All test plans passed using a similar criteria to that of the predicate. Based on results of this testing the device was found to have a safety and effectiveness profile similar to the predicate device, supporting the claim of substantial equivalence.

8 TECHNOLOGICAL COMPARISON WITH THE PREDICATE DEVICES

The primary technological components of the device and its predicate device are an independent dose calculation algorithm and functionality that allows comparison between an independentlycalculated dose and a dose generated by a treatment planning system, all for quality assurance purposes. The technological characteristics are believed to be substantially equivalent to the predicate device. This is summarized in the table below:

Area	SciMoCa (primary predicate Device)	Delta4 Insight
Intended Use	SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance	Delta4 Insight is a software intended to provide quality assurance of the radiotherapy treatment process by an independent dose calculation. Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to modify or influence radiation treatments. Delta4 Insight is to be used only by trained radiation oncology personnel for quality assurance purposes.
	purposes.
Intended User	The intended user is ahealth care professional inthe field of radiotherapylike a medical physicist ora dosimetrist who havebeen educated in the safeuse of the device.	Same as predicate device
Spatial use context	The device is a softwareprogram used on acomputer in a radiotherapydepartment	Same as predicate device
Social use context	Only health careprofessionals have accessto the software. See"Intended user"	Same as predicate device
Hygienic use context	N/A- Software program	Same as predicate device
Physical use context	The device is a softwareprogram installed on acomputer in a radiotherapydepartment. Radiotherapydepartments have highlycontrolled environmentalconditions to allow forpatient comfort. Thetemperature is typically verystable at about 22 C°. Also,the humidity is typicallycontrolled (non condensing,30-70%),	Same as predicate device
Activity use context	Independent calculation ofradiotherapy dose is set upto calculate automatically.User can access andanalyze results using theprogram just like anyother PC program- oftenby sitting in front of thescreen and interacting witha mouse and short phrasesof text. No furtherphysical interaction isrequired.	Same as predicate device
Biocompatibility	N/A- Software program	Same as predicate device
Communication	TCP/IP protocol betweenserver and clients throughhospital network. Inputfiles sent to server viaDICOM protocol.	Same as predicate device
Energy delivered	No energy is delivered.	Same as predicate device
	Device is a software
Intended medical indication	See “Intended Use”	See “Intended Use”
Intended patient population	Verification of treatment plans of patients undergoing radiotherapy treatments-typically curative or palliative treatments	Same as predicate device
Intended part of the body or type of tissue applied to or interacted with	The device is never applied to a body part. No patients ever interact with the device. No patients are ever intended to touch the PC.	Same as predicate device
Intended user profile	The device is a software.See “Intended user”	See “Intended user”
Intended condition of use (environment, including hygienic requirement, frequency of use, location, mobility)	See “IntendedUse environment”	See “Intended Use environment”
Sterile or non sterile	N/A the device is a software. PC (not part of the device) is non-sterile	Same as predicate device
Single or re-usable	N/A device is a software	Same as predicate device
Hospital or home use	The device is used in a radiotherapy device in a hospital	Same as predicate device
Measured quantity	Software uses input from the treatment planning system for an independent dose calculation.	Same as predicate device
Operating Principle	The software is independent of any measuring device or treatment planning system. The software receives data from the treatment planning system and independently calculates dose. The user can then analyze the dose calculated with the software and compare with the dose from the treatment planning system.	Same as predicate device
	Various metrics areavailable for analysis.
Software analysis	Comparing TPS dose withdose calculated from PCprogram	Same as predicate device
Dose calculation enginetype	Monte Carlo	Same as predicate device
Dose calculation engine& viewing stationarrangement	Dose calculated on aserver inside hospital.User can access resultsfrom multiple deviceswhich are on the samenetwork.	Same as predicate device
Main inputs	TPS dose, plan, CT, andstructures. Beam modelinformation and CT todensity table.	Same as predicate device
Commissioning datacollection	Machine specific beaminformation (proprietarybeam modeling)	Same as predicate device
Dose reporting type	Dose to water or dose tomedium	Same as predicate device
Accuracy/Performanceof calculation	When comparing the dosecalculation results ofpatient plans to a referencealgorithm (Acuros), 97%of the dose voxels withmore than 5% of themaximum dose pass agamma criteria of2%/2mm [Hoffman et al,Validation of the Acuros XBdose algorithm versus MonteCarlo for clinical treatmentplans. MedPhys 2018 June 16].	Calculation results ofpatient plans to a referencealgorithm (Monaco,Acuros) have a similargamma pass rate to that ofthe predicate.

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Although proprietary details of the calculation algorithms differ, the technological characteristics of the device are the same as the predicate. The intended use of the new device is contained within the intended use of the predicate device. Performance test plans using the device passed with a similar gamma criteria to that of the predicate.

CONCLUSIONS 9

The non-clinical performance data support the safety of the device and the software verification and validation demonstrate that the device performs as intended in the specified use conditions.

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Performance test plans using the device passed with a similar gamma criteria to the predicate, demonstrating that the device performs comparably to the predicate device that is currently marketed for a comparable intended use. It is the opinion of Scandidos AB that the device, Delta4 Insight, is as safe, is as effective, and performs as well as the predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.