ArcherQA is a software product intended to provide quality assurance of a radiation treatment plan generated by a commercial treatment planning system (TPS) by allowing a clinician to re-calculate dose parameters with dose calculation algorithms independent from the commercial TPS and compare the two set of dose information. ArcherQA is not a TPS or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.

Device Description

ArcherQA (v1.0) is a standalone software product used within a radiation therapy clinic for quality assurance ( Q A ) and treatment plan verification via recalculation of the dose with a GPU-based independent Monte Carlo dose calculation algorithm. ArcherQA is neither a radiation delivery device (e.g. a linear accelerator) nor a Treatment Planning System (TPS). ArcherQA cannot design or transmit instructions to a delivery device or control any other medical device. ArcherQA is an analysis tool meant solely for QA purposes when used by trained medical professionals. Being a software-only QA tool, ArcherQA never comes into contact with patients. ArcherQA performs dose calculation verifications for radiation treatment plans by independently calculating radiation dose. Using both algorithm and hardware-enhanced Monte Carlo methods, ArcherQA can verify the final dose for radiotherapy plans. The calculation is based on read-in treatment plans that are initially calculated by a TPS. ArcherQA supports photon and electron dose calculation. The treatment modalities that can be evaluated by ArcherQA include: three-dimensional conformal radiotherapy (3D CRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic radiosurgery (SRS), stereotactic body radiotherapy (SBRT). ArcherQA also performs dose delivery OA by using the measurement data recorded in a linear accelerator's delivery log files to compare with calculated the delivery dose. This is presented to the end user in a software component of ArcherQA called Fraction Check.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for ArcherOA (V1.0):

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA letter and 510(k) summary do not explicitly state quantitative acceptance criteria or a direct comparison table with specific performance metrics (e.g., accuracy percentages, gamma pass rates with thresholds). Instead, the performance is described in a more general qualitative manner, focusing on agreement with a predicate device.

Table 1: ArcherQA Performance Claims

Acceptance Criteria (Implied)	Reported Device Performance
Performs to specifications and works as designed.	"Test results demonstrate conformance to applicable requirements and specifications."
Provides clinical dose verification in radiotherapy equivalent to predicate devices.	"Bench testing against the predicate device SciMoCa with 30 randomly selected samples from available database demonstrates good agreement, proving that both devices can be used as equivalent third-party independent software for clinical dose verification in radiotherapy."
As safe, as effective, and performs as well as predicate devices.	"ArcherQA is believed to be substantially equivalent to predicate devices in terms of its indications for use, technical characteristics, and overall performance." and "The information provided in this submission indicates the subject device is as safe, is as effective, and performs as well as predicate devices."

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

Sample Size for Test Set: 30 randomly selected samples.
Data Provenance: "From available database." The document does not specify the country of origin of this data, nor does it explicitly state whether it was retrospective or prospective. Given it was "available," it is highly likely to be retrospective data.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The comparison was made against a predicate device (SciMoCa) which itself performs dose calculations. The assumption is that the SciMoCa calculations served as a reference or a "truth" proxy for comparison.

4. Adjudication Method for the Test Set

The document describes "bench testing against the predicate device SciMoCa" and demonstrating "good agreement." This implies a direct comparison method rather than an expert adjudication process for the test set ground truth. The predicate device's output was the reference point.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The device (ArcherQA) is a standalone software for quality assurance and dose calculation verification; it does not involve human readers directly improving their performance with or without AI assistance in the way an MRMC study typically assesses. Its purpose is to verify the output of a commercial Treatment Planning System (TPS).

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

Yes, a standalone performance evaluation was done. The "bench testing against the predicate device SciMoCa" directly assesses the algorithm's performance in calculating dose parameters independently, without human intervention in the calculation process.

7. The Type of Ground Truth Used

The "ground truth" for the test set was implicitly the dose calculations generated by the predicate device, SciMoCa. The study aimed to show "good agreement" between ArcherQA's calculations and SciMoCa's calculations.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for any training set. It focuses solely on the validation against the predicate device. As a dose calculation verification software, it might not have a "training set" in the traditional machine learning sense that predicts an outcome, but rather relies on established physics models (Monte Carlo).

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

Since information about a training set is not provided, details on how its ground truth was established are also not available in the supplied text.

Summary

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January 5, 2024

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, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Wisdom Technologies., Inc. % Wei Wang Consultant 11 Longstreet IRVINE, CA 92620

Re: K231273

Trade/Device Name: ArcherOA (V1.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: December 5, 2023 Received: December 5, 2023

Dear Wei Wang:

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).

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

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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 (QS) 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,

Loca 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

Submission Number (if known)

K231273

Device Name

ArcherQA (V1.0)

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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Image /page/3/Picture/1 description: The image shows a logo for Wisdom Tech. The logo features a stylized human figure in blue, standing in front of a yellow and orange sunburst. To the right of the figure are the words "WISDOM TECH" in blue, with some Chinese characters above it. The logo is clean and modern, and the colors are bright and eye-catching.

510(k) Summary

The following information is provided as required by 21 CFR 807.92

I. SUBMITTER

Name: Wisdom Technologies., Inc.

Address: 4th Floor, Building F2, Phase II, Innovation Industrial Park, Hefei, Anhui, China 230088

Phone: +86-0551-65116387

Email: registration(@wisdom-tech.online

Contact Person: Wei Wang, Consultant, Regulatory Affairs Phone: 949-7849283

Date Prepared: April 26, 2023

II. DEVICE

Subject Device Name: ArcherQA v1.0 Common/Trade Name: ArcherQA Product Code and Classification: Medical charged-particle radiation therapy system IYE | 21 CFR 892.5050 | Class II

III. PREDICATE DEVICES

Primary: K180595 SciMoCa (Radialogica LLC) Reference: K203669 Mobius3D (Varian Medical Systems, Inc.)

DEVICE DESCRIPTION IV.

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ArcherQA performs dose calculation verifications for radiation treatment plans by independently calculating radiation dose. Using both algorithm and hardware-enhanced Monte Carlo methods, ArcherQA can verify the final dose for radiotherapy plans. The calculation is based on read-in treatment plans that are initially calculated by a TPS. ArcherQA supports photon and electron dose calculation. The treatment modalities that can be evaluated by ArcherQA include: three-dimensional conformal radiotherapy (3D CRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic radiosurgery (SRS), stereotactic body radiotherapy (SBRT).

ArcherQA also performs dose delivery OA by using the measurement data recorded in a linear accelerator's delivery log files to compare with calculated the delivery dose. This is presented to the end user in a software component of ArcherQA called Fraction Check.

INDICATIONS FOR USE V.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

The primary technological components of ArcherQA and its predicate devices are independent dose calculation algorithms and functionalities that allow comparison between an independently-calculated dose information and those generated by a commercial TPS for the purpose of quality assurance. Both are software devices that receive inputs related to radiological images to estimate absorbed dose using the well-established algorithms; Both are software devices for prescription use in a professional environment with no patient contact.

There are no known differences in technological characteristics between the subject device and the predicate devices that raise any questions of safety or effectiveness. The technological characteristics of the subject device are believed to be substantially equivalent to the predicate devices.

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Substantial Equivalence Comparison Table

Area of	Subject Device-	Primary-	Reference-Mobius3D
Comparison	ArcherQA	SciMoCa(K180595)	(K203669)
RegulationNumber/code	21 CFR 892.5050 IYE	21 CFR 892.5050 IYE	21 CFR 892.5050 IYE
RegulationName	Medical charged-particleradiation therapy system	Medical charged-particleradiation therapy system	Medical charged-particleradiation therapy system
Indicationsfor Use	ArcherQA is a softwareproduct intended toprovide quality assuranceof a radiation treatmentplan generated by acommercial treatmentplanning system (TPS) byallowing a clinician to re-calculate dose parameterswith dose calculationalgorithms independentfrom the commercial TPSand compare the two set ofdose information.ArcherQA is not a TPS or aradiation delivery device. Itis to be used only bytrained radiation oncologypersonnel for qualityassurance purposes.	SciMoCa is a softwareproduct intended to providequality assurance of aradiotherapy dosecalculated by a treatmentplanning system by allowinga clinician to re-calculate thedose with an independentdose calculation algorithmand compare the two doses.SciMoCa is not a treatmentplanning system or aradiation delivery device. Itis to be used only by trainedradiation oncologypersonnel for qualityassurance purposes.	Mobius3D software is used forquality assurance, treatmentplan verification, and patientalignment and anatomyanalysis in radiation therapy. Itcalculates radiation dosethree-dimensionally in arepresentation of a patient ora phantom. The calculation isbased on read-in treatmentplans that are initiallycalculated by a treatmentplanning system and mayadditionally be based onexternal measurements ofradiation fields from othersources such as linac deliverylog data. Patient alignmentand anatomy analysis is basedon read-in treatment planningimages (such ascomputed tomography) andread-in daily treatmentimages (such as registeredcone beam computedtomography).Mobius3D is not a treatmentplanning system. It is only tobe used by trained radiationoncology personnel as aquality assurance tool.
Algorithm	Monte Carlo	Monte Carlo	Collapsed ConeConvolution/Superposition
Input	Plan parameters	Plan parameters	Plan parameters
Output	3D dose calculation	3D dose calculation	3D dose calculation
Dose MapFormat	DICOM RT3.0	DICOM RT3.0	DICOM RT3.0
types of dosecalculations	photon, electron	photon, electron	photon, electron
Types ofimage filessupported	CT images	CT images	CT images
Treatmenttypes	3D, IMRT, VMAT,SBRT, SRS	3D, IMRT, VMAT,SBRT, SRS	IMRT, VMAT, dynamic /virtual wedge, SRS
Analysismodes	• DVH Graph• Target Coverage• DVH Limits• 3D Gamma• Beam Information• ROI Overview• Notes and Approvals	• DVH Graph• Target Coverage• DVH Limits• 3D Gamma• Beam Information• ROI Overview• Notes and Approvals	• DVH Graph• Target Coverage• DVH Limits• 3D Gamma• Beam Information• ROI Overview• Notes and Approvals
UsageEnvironment	for prescription use in aprofessional environmentby trained radiationoncology personnel	for prescription use in aprofessional environment bytrained radiation oncologypersonnel	for prescription use in aprofessional environment bytrained radiation oncologypersonnel
PatientContact	None	None	None

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PERFORMANCE DATA VII.

Software verification and validation were conducted, and the process was documented per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Verification and Validation tests were executed to verify that the product performed to specifications and worked as designed. Test results demonstrate conformance to applicable requirements and specifications. Bench testing against the predicate device SciMoCa with 30 randomly selected samples from available database demonstrates good agreement, proving that both devices can be used as equivalent third-party independent software for clinical dose verification in radiotherapy. No animal studies or clinical tests were required for validation of the software.

VIII. CONCLUSION

ArcherQA is believed to be substantially equivalent to predicate devices in terms of its indications for use, technical characteristics, and overall performance. The information provided in this submission indicates the subject device is as safe, is as effective, and performs as well as predicate devices. Therefore, it is in the opinion of Wisdom Technologies, Inc. that the medical device, ArcherOA, is substantially equivalent to 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.