EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are planned to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.

Device Description

EDOSE is a three-dimensional dose verification system making IMRT verification becomes accurate, efficient and fast. This system fully supports Varian and Elekta accelerators; it can verify conventional IMRT, IMRT and VMAT. With Collapsed Cone convolution algorithm, it realizes the reconstruction of the three-dimensional dose and combined with the CT image, making the three-dimensional distribution of the dose at a glance. By using CUDA parallel algorithms, EDOSE quickly and efficiently provide the entire program as well as the calculation results of individual GAMMA radiation field, and visually display GAMMA distribution. Meanwhile, EDOSE provides automatic correction of absolute dose and EPID position to support DVH comparison chart and the move of isodose curve. Through a series of powerful functions, the accelerator quality assurance has become so easy.

AI/ML Overview

The provided text is a 510(k) summary for the EDOSE device, detailing its substantial equivalence to a predicate device, Dosimetry Check with Exit Dose. While it discusses the device's intended use and general characteristics, it does not contain a detailed study with acceptance criteria and reported device performance, nor does it provide information on sample sizes, ground truth establishment, or multi-reader studies.

The document only states the following regarding performance: "Review of ID 3 - Performance, both are the same, so the SE is not affected." This implies that the performance is considered substantially equivalent to the predicate device, but no specific performance metrics or acceptance criteria for EDOSE are presented.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Available	Not Available
(No specific acceptance criteria or performance metrics for EDOSE are mentioned in the provided text. The document only states that the performance of EDOSE is considered "the same" as the predicate device, Dosimetry Check with Exit Dose, implying substantial equivalence without specific data.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not Available
Data Provenance (Country of Origin): Not Available
Data Provenance (Retrospective/Prospective): Not Available

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not Available
Qualifications of Experts: Not Available

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not Available

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

MRMC Study Conducted?: No (Not mentioned or implied in the text. The device is described as an "independent quality assurance (QA) tool," not a reader assistance tool.)
Effect Size: Not Applicable (as no such study was mentioned)

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

Standalone Performance Study Conducted?: Not explicitly stated, however, the device is described as an "independent quality assurance (QA) tool" that "can calculate and check the dose distribution." This strongly suggests standalone functionality, but no specific study or metrics are provided. The text mentions "the software system test and the product design verification are performed as the same single testing activity. During the system test period, all of the product level and software requirements have been tested and verified," which broadly refers to software testing rather than a clinical performance study.

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

Type of Ground Truth: Not Available (The device "verifies that the treatment plan is in fact successfully delivered" and "checks the dose distribution to be or has been delivered," implying comparison against a planned or measured dose, but the specific nature of the ground truth for validation is not detailed.)

8. The sample size for the training set

Sample Size for Training Set: Not Available (No mention of a training set or machine learning model training.)

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

Ground Truth Establishment for Training Set: Not Applicable (No training set or machine learning model is mentioned.)

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2015

Guangzhou Raydose Software Technology, LLC % Mr. Dennis Dong Sales & Marketing Director No.850 East Dongfeng Road, Guangzhou City Guangdong Province, Room 502, Glorious Tower Guangzhou, 510060 P. R. CHINA

Re: K150767

Trade/Device Name: EDOSE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 6, 2015 Received: July 10, 2015

Dear Mr. Dong:

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. 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara For

Robert Ochs, Ph.D. Acting 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) K150767

Device Name

EDOSE

Indications for Use (Describe)

EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are plamed to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR807.92 (a) (1)]

August 13, 2015

2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor:	Guangzhou Raydose Software Technology., LLC.
Address:	Room 502, Glorious Tower, No.850 East Dongfeng Road,Guangzhou city, Guangdong Province, P.R.China
Contact Name:	Dennis Dong
Telephone No.:	+86-20-87764746-8020
Fax No.:	+86-20-87764746-8024
Email Address:	dennis.dong@raydose.com

3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]

Trade Name:	EDOSE
Common Name:	Standalone Software Quality Control System
Classification:	Medical Charged-particle Radiation Therapy System
Product code:	IYE
Classification Panel:	Radiology
Device Class:	II

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

The identified predicates within this submission are as follows:

Math Resolutions, LLC, Dosimetry Check with Exit Dose has been cleared by FDA through 510(k) No.K101503 (Decision Date – August 04, 2010),

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5. Description of the Device [21 CFR 807.92(a) (4)]

With technological development, precise radiotherapy has become the primary means of radiotherapy techniques. However, due to higher requirements that Radiation therapy technology refinement purposed, it also produced a greater risk of potential treatment failure. The greater the level of potential therapeutic accident, which makes quality assurance become a necessary step to ensure that radiotherapy can implement, but also for the quality assurance the work presents a higher demand. EDOSE is a three-dimensional dose verification system making IMRT verification becomes accurate, efficient and fast. This system fully supports Varian and Elekta accelerators; it can verify conventional IMRT, IMRT and VMAT. With Collapsed Cone convolution algorithm, it realizes the reconstruction of the three-dimensional dose and combined with the CT image, making the three-dimensional distribution of the dose at a glance. By using CUDA parallel algorithms, EDOSE quickly and efficiently provide the entire program as well as the calculation results of individual GAMMA radiation field, and visually display GAMMA distribution. Meanwhile, EDOSE provides automatic correction of absolute dose and EPID position to support DVH comparison chart and the move of isodose curve. Through a series of powerful functions, the accelerator quality assurance has become so easy.

6. Indications for Use [21 CFR 807.92(a)(5)]

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7. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

7.1 Intended uses:

ID	ComparisonItem	Proposed DeviceEDOSE	Predicate DeviceDosimetry Check with ExitDose
1	IntendedUse	EDOSE is indicated to beused as an independentquality assurance (QA) toolfor the treatment planningsystem, to verify that thetreatment plan is in factsuccessfully delivered to thepatient. EDOSE is used byoncologist, radiotherapyphysicist and/or radiotherapydosimetrist to check theaccuracy of the delivery byhigh energy linear acceleratorthat are planned to be appliedor have been applied to apatient. By using the specificmeasuring device, theproduct can output the dosedistribution of the patient orphantom based on treatmentfield image data andtheoretical calculation. Theproduct can calculate andcheck the dose distribution tobe or has been delivered. Inaddition, the product may beused to display the dosedistribution on other fusedimage sets which couldprovide additional clinicalinformation to the radiationoncologist regarding thetreatment	The product is to be used byradiation oncologist, dosimet-rist, and radiation therapyphysicist to check thecorrectness of the x-raytreatment fields from high energytreatment machines that areplanned to be or have beenapplied to a patient. This productis to be used in addition to thetreatment planning system toprovide a means for additionaland redundant verification thatthe plan is in fact successfullyaccomplished. This product isnot a treatment planning systemand is not to be used as one. Thisproduct only checks the applieddose based on the measurementof each x-ray field and atheoretical calculation. Thisproduct does not provide anyquality assurance that the fieldsare. in fact correctly applied toand correctly aligned with thepatient anatomy a planned. Inaddition, the product may beused to display the above doseon other fused image sets whichcould provide additional clinicalinformation to the radiationoncologist regarding thetreatment
ID	ComparisonItem	ProposedDeviceEDOSE	Predicate DeviceDosimetry Checkwith Exit Dose
2	General
2.1	Classification Name	Quality Control forMedical Charged-particle RadiationTherapy Systems.	Quality Control forMedical Charged-particle RadiationTherapy Systems.
2.2	Product Code	IYE	IYE
2.3	Regulation Number	892.5050	892.5050
2.4	Panel	General & PlasticSurgery	General & PlasticSurgery
2.5	Class	Class II	Class II
3	Performance
3.1	Pre-treatment images	Yes	Yes
3.2	Exit images	Yes	Yes
3.3	Compute dose to patient	Yes	Yes
3.4	Compare to planning system dose	Yes	Yes
3.5	Used for verifying the correctness ofradiation therapy treatments	Yes	Yes
3.6	Uses a line in the transverse planethrough the radiation field measurementprovided to Dosimetry Check. A priormeasured longitudinal profile is appliedto each detector signal to complete theradiation field.	No	No
3.7	Generates a report as described in theDosimetry Check manual using eitherthe auto-report feature, or the user mayconstruct their own report using theevaluate tools.	Yes	Yes
3.8	Photons (x-ray)	Yes	Yes

Table 1 Intended Use Comparison

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7.2 Comparison table

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ID	ComparisonItem	ProposedDeviceEDOSE	Predicate DeviceDosimetry Checkwith Exit Dose
3.9	Electrons	No	No
3.10	Protons	No	No
3.11	Ability to use the TomoTherapy detectordata measured in a pretreatment dry runwithout the patient and the detector datataken during treatment	No	No
3.12	Operating Systems	MicrosoftWindows XP,Windows 7,Windows 8	Microsoft WindowsXP, Windows Vista.Windows 7, andUbuntu 9.04 (Linux)

7.3 Discussion of Differences:

It is reasonable that there are some differences between our new device and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).

Review of ID 1 - Intended use, both of them are used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy Linear accelerator that are planned to be applied or have been applied to a patient. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected

Review of ID 2 - General, both are the same, so the SE is not affected.

Review of ID 3 - Performance, both are the same, so the SE is not affected.

8. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Guangzhou Raydose Software Technology., LLC. concludes that EDOSE is substantially equivalent to predicate devices with regard to safety and effectiveness.

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Since EDOSE is a software product, the software system test and the product design verification are performed as the same single testing activity. During the system test period, all of the product level and software requirements have been tested and verified.

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.