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 purposes.

Device Description

SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. 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 purposes.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria and the comprehensive study that proves the device meets those criteria. It mentions "Validation testing involved simulated clinical workflows and environment, as well as algorithm testing" and that the product "passed verification testing and was deemed safe and effective for its intended use." However, it lacks specific metrics, study designs, or methodologies that would allow for a complete answer to your detailed questions.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based on the limited information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	"Passed verification testing and was deemed safe and effective for its intended use."
Not specified	"The product was deemed fit for clinical use."
Not specified	"Performed to specifications and works as designed."

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

Sample Size: Not specified. The document mentions "Over 700 test procedures were executed," but this refers to the number of test procedures, not the number of distinct cases or data samples in a test set.
Data Provenance: Not specified. There is no information about country of origin or whether the data was retrospective or prospective.

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.

4. Adjudication method for the test set

Adjudication Method: 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

There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. The device, SciMoCa, is described as an "independent dose calculation algorithm" for quality assurance, not as an AI-assisted diagnostic tool for human readers.

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

Yes, based on the description, the primary validation would likely be standalone performance. The device's function is to "re-calculate the dose with an independent dose calculation algorithm and compare the two doses." This implies the algorithm's output is compared against a reference (the treatment planning system's calculated dose), which is a form of standalone evaluation. However, specific performance metrics for this standalone performance (e.g., accuracy, deviation limits) are not provided in the text.

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

The ground truth for dose calculation in radiotherapy QA typically involves comparing the device's recalculated dose against an established reference dose (e.g., from a validated treatment planning system or a benchmark phantom calculation). The text states SciMoCa "allows a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses," implying the "ground truth" or reference is the dose from the primary treatment planning system. However, the exact methodology for establishing this comparison and what constitutes "ground truth" for the validation itself is not detailed.

8. The sample size for the training set

Training Set Sample Size: Not specified. The document refers to "algorithm testing" but provides no details on training data.

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

Ground Truth Establishment for Training Set: Not specified.

Summary

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April 4, 2018

Radialogica LLC % Ms. Debra Vigil Director of Quality Assurance and Regulatory Affairs 511 N. Garrison Avenue SAINT LOUIS MO 63103

Re: K180595

Trade/Device Name: SciMoCa Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 1, 2018 Received: March 6, 2018

Dear Ms. Vigil:

We have reviewed vour 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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180595

Device Name SCiMoCa

Indications for Use (Describe)

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 purposes.

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 Statement

510(K) Owner

Radialogica, LLC 511 N Garrison Ave. St. Louis, MO 63101 Tel: (800) 515-9132 Fax: (888) 788-5946

Contact person

Debra Vigil debra@radialogica.com Ph: (800) 515-9132, ext. 301

Preparation Date

1 March 2018

Trade Name

SciMoCa

Common Name

Secondary Check QA Software

Classification Name

Accelerator, Linear, Medical 21 CFR 892.5050 Product Code: IYE

Class II

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Predicate Devices

o K140660 Mobius3D (Mobius Medical Systems, LP)
. K161946 Model 1217028 DoseCHECK (Sun Nuclear Corporation)

Device Description:

Intended Use:

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 purposes.

Technological Characteristics:

The primary technological components of SciMoCa and its predicate devices are an independent dose calculation algorithm and functionality that allows comparison between an independently-calculated 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 devices.

Performance Testing Summary:

Validation testing involved simulated clinical workflows and environment, as well as algorithm testing. These are described in detail in section 18. The product was deemed fit for clinical use.

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Non-Clinical Testing Summary:

Verification tests were written and executed, focused on verifying that the product performed to specifications and works as designed. Over 700 tests procedures were executed, including tests to verify requirements for functionality, tests to ensure risk mitigations function as intended, and regression tests to ensure the safety and effectiveness of functionality. SciMoCa passed verification testing and was deemed safe and effective for its intended use.

Conclusion:

SciMoCa is believed to be substantially equivalent to the predicate devices in terms of its indications for use, technical characteristics, and overall performance. The information provided in this submission indicates substantial equivalence to the predicate devices. It is in the opinion of Radialogica, LLC that the medical device, SciMoCa, is as safe, is as effective, and performs as well as the predicate devices.

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.