AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck 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.
AccuCheck performs using the TPS Check module to check related parameters in the radiotherapy plan to determine if the plan is executable by the linear accelerator( LINAC).
AccuCheck also performs using the Dose Check module to conduct dose calculation verification for radiation treatment plans before radiotherapy by doing an independent calculation of radiation dose using Monte Carlo algorithm. Radiation dose is initially calculated by a Treatment Planning System (TPS).
AccuCheck performs using the Transfer Check module to verify the integrity of the treatment plan transmitted from TPS to the LINAC to check if errors occur during the transmission.
AccuCheck performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a LINAC's delivery log files to reconstruct executed plan and calculate delivered dose. This is achieved through the software module of the Subject Device called Pre-treatment Check and Treatment Check. The difference lies in the usage scenario, where Pre-treatment Check processes the logs of the first execution of the treatment plan in LINAC without a patient actually being treated, while treatment check processes the logs of the second and subsequent execution of the treatment plan in LINAC with a patient actually being treated. AccuCheck cannot be used for log verification, but rather for dose calculation based on logs such as LINAC delivery log data. The reconstruct of the executed plan and calculation of the delivered dose from delivery logs on LINAC machines, including Varian LINAC and Elekta LINAC, are supported by AccuCheck.
The product provides with multiple tools to assist the analysis, including dose volume histogram, Gamma analysis, target coverage, Gamma passing rate of each ROI, dose statistics and clinical targets evaluation.

AI/ML Overview

AccuCheck: Acceptance Criteria and Performance Study

This document outlines the acceptance criteria for the AccuCheck device and details the study conducted to demonstrate the device's performance against these criteria.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary describes a secondary dose calculation verification test as a key performance evaluation. While explicit numerical acceptance criteria are not presented in a table format, the narrative indicates that "The results of all test cases passed the test criteria". Based on the checked items during the test, the implied acceptance criteria are the accurate and consistent representation of various dose analysis metrics by AccuCheck when compared to FDA-cleared Treatment Planning Systems (TPS).

Table 1: Implied Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Accurate Dose-Volume Histogram (DVH) representation	Passed for all test cases. Differences in DVH limits were checked.
Accurate Dose Index calculation	Passed for all test cases. Differences in dose indices were checked.
Accurate 3D Dose Distribution representation	Passed for all test cases.
Accurate Dose Profile representation	Passed for all test cases.
Accurate Gamma Distribution calculation	Passed for all test cases.
Correct Pass/Fail results for DVH limits	Passed for all test cases.
Accurate 3D Gamma Passing Rate calculation	Passed for all test cases.
Acceptable differences in dose indices compared to FDA-cleared TPS	Passed for all test cases.

2. Sample Size and Data Provenance

Sample Size for Test Set: 20 patients.
Case Distribution:
- 10 samples for Head and Neck cancers.
- 5 samples for Chest cancers.
- 5 samples for Abdomen cancers.
- Specific cancer types mentioned: Brain, Lung, Head and Neck, and GI cancers.
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. However, it mentions that the patients "have been treated with IMRT and VMAT techniques," suggesting the use of retrospective data from actual patient treatments. The joint testing devices included two FDA-cleared LINACs and two FDA-cleared TPS systems, implying that these treatment plans and potentially associated patient data originated from clinical settings where these devices are used.

3. Number and Qualifications of Experts for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the ground truth is established by the "FDA cleared TPS" (Treatment Planning Systems), implying that the generated dose calculations from these cleared systems serve as the reference for accuracy. The expertise is inherently embedded in the design and validation of these cleared TPS and the physics teams operating them in clinical practice.

4. Adjudication Method

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The evaluation appears to be a direct comparison between the AccuCheck's calculations and those of the FDA-cleared TPS, with the "test criteria" seemingly pre-defined based on acceptable differences or concordance metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study described focuses on the device's standalone performance compared to established TPS. There is no information provided regarding human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Secondary Dose Calculation verification test" directly assesses the AccuCheck device's ability to perform secondary dose calculations independently and accurately when compared against established FDA-cleared TPS. The device operates without human intervention in its calculation process for this specific test.

7. Type of Ground Truth Used

The ground truth used for the secondary dose calculation verification test is based on the dose calculations generated by FDA-cleared Treatment Planning Systems (TPS). This implies a reference to established and regulatory-approved dose calculation methods.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set. The descriptions focus solely on the verification and validation (test) phase.

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

The document does not provide information on how the ground truth for any training set was established, as it does not explicitly mention a training phase for the device development. The performance data section describes verification and validation using established TPS as the reference.

Summary

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July 20, 2023

Image /page/0/Picture/1 description: The image contains 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Manteia Technologies Co., Ltd. % Yingkai Lin RA Manager 1903-1904, B Tower, Zijin Plaza No.1811 Huandao East Road Xiamen. Fujian 361001 CHINA

Re: K223834

Trade/Device Name: AccuCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 22, 2023 Received: June 22, 2023

Dear Yingkai Lin:

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

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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 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,

Lora 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

Enclosure

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Indications for Use

510(k) Number (if known) K223834

Device Name AccuCheck

Indications for Use (Describe)

AccuCheck 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

The following information is provided as required by 21 CFR 807.92.

The assign 510(k) Number: K223834

1. SUBMITTER

Manteia Technologies Co., Ltd.

1903-1904, B Tower, Zijin Plaza, No.1811 Huandao East Road, Xiamen,, China

Establishment Registration Number: 3016686005

Contact Person: Chao Fang

Position: RA&OA Manager

Email: fangchao@manteiatech.com

Date of Preparation: July 20, 2023

2. Identification of Proposed Device

Device/Trade Name: AccuCheck Common Name: Radiotherapy Plan Quality Assurance System Regulatory Information Classification Name: accelerator, linear, medical Classification: II Product Code: IYE Regulation Number: 21CFR 892.5050

3. PREDICATE DEVICE

Review Panel: Radiology

Predicate Device: Mobius 3D v4.0 (K203669) Reference Device: INTDose (K213137)

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510(K) Summary

4. DEVICE DESCRIPTION

AccuCheck performs using the TPS Check module to check related parameters in the radiotherapy plan to determine if the plan is executable by the linear accelerator( LINAC).

AccuCheck also performs using the Dose Check module to conduct dose calculation verification for radiation treatment plans before radiotherapy by doing an independent calculation of radiation dose using Monte Carlo algorithm. Radiation dose is initially calculated by a Treatment Planning System (TPS).

AccuCheck performs using the Transfer Check module to verify the integrity of the treatment plan transmitted from TPS to the LINAC to check if errors occur during the transmission.

AccuCheck performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a LINAC's delivery log files to reconstruct executed plan and calculate delivered dose. This is achieved through the software module of the Subject Device called Pre-treatment Check and Treatment Check. The difference lies in the usage scenario, where Pre-treatment Check processes the logs of the first execution of the treatment plan in LINAC without a patient actually being treated, while treatment check processes the logs of the second and subsequent execution of the treatment plan in LINAC with a patient actually being treated. AccuCheck cannot be used for log verification, but rather for dose calculation based on logs such as LINAC delivery log data. The reconstruct of the executed plan and calculation of the delivered dose from delivery logs on LINAC machines, including Varian LINAC and Elekta LINAC, are supported by AccuCheck.

The product provides with multiple tools to assist the analysis, including dose volume histogram, Gamma analysis, target coverage, Gamma passing rate of each ROI, dose statistics and clinical targets evaluation.

5. INDICATIONS FOR USE

AccuCheck 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.

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6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

AccuCheck designed the corresponding functional modules considering the timeline of radiotherapy treatment. AccuCheck verified the feasibility and dose accuracy of the treatment plan before implementation. After execution, AccuCheck verified the consistency of data transmission and read the accelerator execution log to restore the treatment plan.

The primary technical feature of AccuCheck and its predicate device is to check the information of the plan files according to relative parameters to ensure the quality of the treatment plan. The verification of dose is an important part of ensuring the quality of treatment plan. When verifying the dose of the treatment plan, AccuCheck and its predicate device are used to perform a secondary dose calculation on the read or imported file and compare with the original plan dose, and present the results in various ways. The technological characteristics are believed to be substantially equivalent to the predicate device. The following comparison table "Device Comparison Table" provides a detailed comparison.

Comparison item	Subject Device	Predicate Device	Reference Device
Regulatory Information
Indication for use	AccuCheck is a qualityassurance software usedfor data transfer integritycheck, secondary dosecalculation with MonteCarlo algorithm, andtreatment plan verificationin radiotherapy.AccuCheck also providesindependent doseverification based onLINAC delivery log afterradiotherapy planexecution.AccuCheck is not atreatment planning systemor a radiation deliverydevice. It is to be usedonly by trained radiationoncology personnel forquality assurancepurposes.	Mobius 3D (K203669)Mobius3D software isused for qualityassurance, treatment planverification, and patientalignment and anatomyanalysis in radiationtherapy. It calculatesradiation dosethree-dimensionally in arepresentation of apatient or a phantom. Thecalculation is based onread-in treatment plansthat are initiallycalculated by a treatmentplanning system and mayadditionally be based onexternal measurements ofradiation fields fromother sources such aslinac delivery log data.Patient alignment andanatomy analysis is	INTDose (K213137)INTDose is a softwareproduct intended tosupport the radiationtherapy treatmentplanning process byproviding independentdose verificationthrough Monte Carlosimulation.INTDose is not atreatment planningsystem or a radiationdelivery device andshould only be used bytrained radiationoncology personnel asa quality assurancetool.

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based on read-intreatment planningimages (such ascomputed tomography)and read-in dailytreatment images (suchas registered cone beamcomputed tomography).Mobius3D is not atreatment planningsystem. It is only to beused by trained radiationoncology personnel as aquality assurance tool.
IndependentSoftware	Yes	Yes	Yes
Product Code	IYE	IYE	IYE
Intended users	Trained radiationoncology personnel	Trained radiationoncology personnel	Trained radiationoncology personnel
Regulation No.	21 CFR 892.5050	21 CFR 892.5050	21 CFR 892.5050
Patient management features
Displaying Patientand plan list	Yes	Yes	Yes
Displaying of PlanCheck Results	Yes	Yes	Yes
DICOM RT	Yes(The device supports CT/CBCT/ MR/ RTStruct/RTPlan,/ RTDose)	Yes(The device supports CT/CBCT/ RTStruct/RTPlan,/ RTDose)	Yes(The device supportsCT/CBCT/ RTStruct/RTPlan,/ RTDose)
Plan parameters checking features
Supported treatmenttechniques	3D-CRT, IMRT, VMAT,SRS, SBRT	3D-CRT, IMRT, VMAT,SRS, SBRT,Brachythreaphy	TomoTherapy®,3D-CRT, IMRT,VMAT
Displaying ofinspection results	Yes	Yes	Yes
Dose verification features based on imported plan
Supported treatmenttechniques	3D-CRT, IMRT, VMAT,SRS, SBRT	3D-CRT, IMRT, VMAT,Brachythreaphy	TomoTherapy®,3D-CRT, IMRT,VMAT
DICOM datasupported by dosecalculation	CT/CBCT/MR, RTDose,RTStructures, RTPlan)	CT/CBCT, RTDose,RTStructures, RTPlan	CT/CBCT, RTDose,RTStructures, RTPlan

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Beam type	Photon	Photon, Electron	Photon
Dose calculationalgorithm	Monte Carlo algorithm	CCC/S algorithm forphoto, PBRA algorithmfor electron	Monte Carlo algorithm
Dose comparison	Yes	Yes	Yes
Displaying ofinspection results	Yes	Yes	Yes
Plan transmission verification features
Supported treatmenttechniques	3D-CRT, IMRT, VMAT,SRS, SBRT	3D-CRT, IMRT, VMAT,SRS, SBRT,Brachythreaphy	TomoTherapy®,3D-CRT, IMRT,VMAT
Consistency checkon transferred plans	Yes	Yes	No
Displaying of checkresults	Yes	Yes	N/A
Dose verification features based on accelerators' log
LINAC log analysis	Varian's Linearaccelerators' log, Elekta'slinear accelerators' log	Varian's Linearaccelerators' log,Elekta's linearaccelerators' log	N/A
Beam type	Photon	Photon, electron	Photon
Dose calculationalgorithm	Monte Carlo algorithm	CCC/S algorithm forphoto, PBRA algorithmfor electron	Monte Carlo algorithm
Dose comparison	Yes	Yes	Yes
Displaying ofinspection results	Yes	Yes	Yes

7. PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence determination.

Software Verification and Validation Testing (Non-Clinical Testing)

Software verification and validation 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." The software for this device was considered as a "major" level of concern.

Test results demonstrate conformance to applicable requirements and specifications. No animal studies or clinical tests have been included in this premarket submission.

Secondary Dose Calculation verification test

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A verification test for the secondary dose calculation of the subject device was perform for 20 patients that have been treated with IMRT and VMAT techniques. For each tumor location, there are 10 samples for Head and Neck cancers, 5 samples for Chest cancers and 5 samples for Abdomen samples, including Brain , Lung, Head and Neck, and GI cancers. The joint testing devices include two FDA-cleared LINACs and two FDA-cleared TPS systems from different vendors. The results of all test cases passed the test criteria and the following items were checked during the test: The dose - volume histogram (DVH), dose index, 3D dose distribution, dose profile, gamma distribution, pass/fail results for the dose - volume histogram (DVH) limits, the 3D gamma passing rate, and differences in dose indices between the subject device and the FDA cleared TPS.

8. Standards Conformance

The subject device conforms in whole or in part with the following standards:

• IEC 62366-1:2015 Medical device Part 1 - Application of usability engineering to medical devices

· IEC 61217:2011 Radiotherapy Equipment Coordinates, Movements and Scales
· IEC 62304:2006+A1:2015 Medical device software Software life cycle processes

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

9. CONCLUSION

AccuCheck 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.

Therefore, Manteia Technologies Co., Ltd. considers the subject device, AccuCheck, is substantially equivalent to the predicate device Mobius3D v4.0 (K203669).

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.