INTDose is a software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation. INTDose is not a treatment planning system or a radiation delivery device and should only be used by trained radiation oncology personnel as a quality assurance tool.

Device Description

INTDose is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It allows clinicians to perform a second check of a radiotherapy dose generated by a treatment planning system by simulating the transport of ionizing radiation in patients using an independent Monte Carlo algorithm. INTDose is implemented such that one or more clients may communicate calculation requests to a central dose calculation server.

While INTDose operates in the field of radiation therapy, it is neither a treatment planning system nor radiation delivery device. INTDose never comes into contact with patients and cannot control treatment delivery devices or any other medical devices. It is an analysis tool to be used only by trained radiation oncology personnel for quality assurance purposes.

AI/ML Overview

This FDA 510(k) clearance letter and summary describe a software product called INTDose, intended for independent dose verification in radiation therapy treatment planning. However, the provided document does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets those criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: The document states that performance was "evaluated and verified" and "established that the device meets its design requirements," but it does not provide specific quantitative acceptance criteria (e.g., dose accuracy within X%) or the results against those criteria.
Sample sized used for the test set and the data provenance: There is no mention of the size of the test set used for verification and validation, nor the origin (country, retrospective/prospective) of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: The device is described as "independent dose verification through Monte Carlo simulation," a quality assurance tool, and an "analysis tool," but it does not specify an AI component that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance. It's a "secondary check QA software." Therefore, it's highly unlikely an MRMC study in this context would involve human readers in the typical sense of interpreting images for diagnosis.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: While the nature of the device (a dose calculation software) implies independent performance, the study details of this standalone performance (what metrics were used, against what ground truth, sample size, etc.) are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document refers to "independent Monte Carlo algorithm" and "second check of a radiotherapy dose generated by a treatment planning system," implying the "ground truth" or reference for comparison would be another established dose calculation method or physical measurement, but the exact nature or method of ground truth establishment is not detailed.
The sample size for the training set: As a Monte Carlo simulation software, it's not explicitly stated that there's a "training set" in the machine learning sense. If there are underlying models that are trained, this information is not provided.
How the ground truth for the training set was established: See above.

What is mentioned in the document:

Device Type: INTDose is "software product intended to support the radiation therapy treatment planning process by providing independent dose verification through Monte Carlo simulation." It's a "Secondary Check QA Software."
Purpose: Quality assurance tool to perform a "second check of a radiotherapy dose generated by a treatment planning system."
Technology: Uses an "independent Monte Carlo algorithm" to simulate the transport of ionizing radiation.
Performance Evaluation (General): "The safety and performance of INTDose has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing."
Conclusion: "Non-clinical verification and validation test results, including simulation performance and software usability, established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate device, and that no new issues of safety and effectiveness were raised."
Compatibility Testing: Successfully completed with specific treatment delivery machines (Accuray TomoTherapy HDA, Varian TrueBeam, Varian Clinac (21EX-Platinum), Varian Clinac (iX), Varian Halcyon). This indicates a form of performance testing, possibly verifying dose agreement or data transfer capabilities.
Risk Management: "Potential hazards were controlled by a risk management plan including risk analysis, risk mitigation, verification and validation."

In summary, while the document confirms that performance testing was conducted for the INTDose device and asserts that it met design requirements and proved substantially equivalent to its predicate, it lacks the detailed quantitative data, sample sizes, ground truth establishment methods, and expert adjudication information typically found in a comprehensive study report. This level of detail is usually found in the full 510(k) submission, not the public summary or clearance letter.

Summary

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Carina Medical LLC % Dr. Xue Feng Chief Executive Officer 1233 Litchfield Lane LEXINGTON KY 40513

Re: K213137

Trade/Device Name: INTDose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: April 11, 2022 Received: April 11, 2022

Dear Dr. Xue Feng:

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); 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,

Julie Sullivan, Ph.D. Assistant Director DHT 8C: 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

Enclosure

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Indications for Use

510(k) Number (if known) K213137

Device Name INTDose

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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Summary 510(k)

K213137

1. Applicant:

Carina Medical LLC 1233 Lichfield Ln Lexington, KY, 40513 USA Contact Name: Xue Feng - Chief Executive Officer Phone: 434-284-1073 Fax: 855-615-2856 E-mail: xfeng@carinaai.com

2. Device:

Trade Name: INTDose Common Name: Secondary Check QA Software Model Number: 1.0 Product Code: IYE Regulation Description: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.5050 Device Class: II

3. Predicate Device:

Trade Name: SciMoCa Manufacturer: Radialogica, LLC Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Device Class: II Product Code: IYE 510(k) Number: K180595 510(k) Clearance Date: 04/04/2018

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CARINA

4. Preparation Date

September 16, 2021

5. Device Description

6. Intended Use

7. Indications for Use Statement

8. Technological Characteristics

The principal technological characteristic of INTDose and its predicate device is a second check dose calculation algorithm that allows clinicians to compare the dose calculated by a treatment planning system to an independently-calculated second check dose for the purpose of quality

info@carinaai.com

+1 434-284-1073

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CARINA

assurance in a radiation medicine clinic. Detailed technological characteristics and indications for use presented in the full set of submitted documentation for this 510(k) application support the claim that INTDose is substantially equivalent to the predicate devices.

9. Performance Data

The safety and performance of INTDose has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Non-clinical verification and validation test results, including simulation performance and software usability, established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate device, and that no new issues of safety and effectiveness were raised.

The following treatment delivery machines have successfully completed compatibility testing with INTDose

Accuray TomoTherapy HDA (v2.1.4)
Varian TrueBeam (v2.0)
Varian Clinac (21EX-Platinum)
Varian Clinac (iX)
Varian Halcyon (v2.0)

Further, during the development, potential hazards were controlled by a risk management plan including risk analysis, risk mitigation, verification and validation.

10. Substantial Equivalence Conclusion

INTDose is believed to be substantially equivalent to the predicate device in terms of its indications for use, technical characteristics, and overall performance. The information provided in this submission indicates substantial equivalence to the predicate device. It is in the opinion of Carina Medical, LLC that the medical device, INTDose, is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness.

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.