The system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.

Device Description

TaiChiC Rotating Gamma System has been designed to deliver radiation treatments in accordance with a prescribed plan. This system is a stereotactic radiotherapy equipment developed by applying the principle and mature technology of Cobalt-60 rotary focusing. It is suitable for brain and head lesions and tumors requiring radiotherapy, and provides image guided stereotactic radiosurgery and precision radiotherapy.

TaiChiC consists of a gantry with a slip ring, a focusing gamma ray treatment head, image guidance subsystem, couch, power supply and electrical cabinet, main cover and treatment bore etc. TaiChiC combines gamma beam stereotactic radiation therapy technology with contemporary advanced image guidance technology (IGRT) to provide image guided stereiotactic radiotherapy and precision radiotherapy.

AI/ML Overview

The provided text describes the TaiChiC Rotating Gamma System, a teletherapy device for stereotactic radiosurgery and precision radiotherapy, and its substantial equivalence determination by the FDA. However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, detailed study designs, or information about human expert involvement for establishing ground truth.

The performance data section broadly states:

Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
Bench Test: Conformance to various IEC standards (60601-2-11, 60601-1-3, 60601-2-68, 61217, 62274, 62366-1, 60601-1-6), RT2, ISO 15223-1, and ISO 10993-1.
Hardware and Software Verification and Validation Testing: Conducted according to 21 CFR §820, ISO 13485, ISO 14971, and FDA guidance for software in medical devices. The software was considered "major" level of concern.
Animal or clinical test: Not applicable.

The conclusion states that verification and validation testing demonstrated that the device "met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use." One quantitative metric mentioned is "Radiologic accuracy < 0.5mm," which is also the specification for the predicate device.

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

Here's an attempt to fill the table and answer the questions based only on the available information, noting when information is missing:

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

Acceptance Criteria Category	Specific Acceptance Criteria (if stated)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1	Complies with IEC 60601-1
EMC	Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2
Bench Testing	Conformance to various IEC standards (60601-2-11, 60601-1-3, 60601-2-68, 61217, 62274, 62366-1, 60601-1-6), RT2, ISO 15223-1, ISO 10993-1	Successful testing performed in accordance with these standards
Radiologic Accuracy	< 0.5mm (implicitly from predicate comparison)	< 0.5mm
Software Level of Concern	"Major" level of concern requirements met	Considered "major" level of concern, V&V conducted as per FDA guidance
Overall Performance	Met specifications and demonstrated substantial equivalence to predicate	Met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use.

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 specified. The document refers to "bench tests" and "hardware and software verification and validation testing" but does not detail a specific test set of medical images or patient data.
Data Provenance: Not specified, as no specific test set of patient data is described. The tests appear to be engineering and software validation rather than evaluation against a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. The document describes engineering and software validation, not a study involving human experts to establish ground truth for clinical cases.

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

Not applicable/Not specified. There is no mention of human adjudication for a clinical test set.

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. The document explicitly states "Animal or clinical test: Not applicable for TaiChiC." This indicates no clinical study, including MRMC, was performed.

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

The device described, TaiChiC Rotating Gamma System, is a hardware teletherapy device for radiation treatment, not an AI algorithm for diagnosis or image analysis. Therefore, a standalone algorithm performance study as typically understood for AI/CADe devices is not applicable here. The performance data focuses on system level compliance and accuracy.

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

Not applicable/Not specified. For the engineering and software tests described, the "ground truth" would be the specified technical requirements and expected device behavior rather than clinical ground truth (e.g., from pathology or expert consensus).

8. The sample size for the training set

Not applicable/Not specified. This device is a radiation therapy system, not an AI/ML model that requires a training set in the conventional sense.

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

Not applicable/Not specified. As it's not an AI/ML model, the concept of a training set and its ground truth establishment doesn't apply.

Summary

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March 12, 2021

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Our United Corporation % Mr. Qi Liu Regulatory Affairs Engineer Room 10301, 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, No.66 Xi'an, Shaanxi 710018 CHINA

Re: K203250

Trade/Device Name: TaiChiC Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: Class II Product Code: IWB Dated: February 3, 2021 Received: February 10, 2021

Dear Mr. Qi Liu:

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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K203250

Device Name TaiChiC

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Premarket Notification [510(k)] Summary OUR UNITED CORPORATION TaiChiC Rotating Gamma System

The following information is provided following the format of 21 CFR 807.92.

I. GENERAL INFORMATION

K203250

Submitter's Name:	OUR UNITED CORPORATION
	Room 10301, 3rd Floor, Unit 1, Block 28, Shou Chuang
	International Business Center, No.66 Fengcheng 12 Road,
	Xi'an Economic & Technological Development Zone, 710018,
	Shaanxi, China.

Contact Person:	Qi Liu
	Phone: +86 15389012257
	Email: qi.liu@ourunited.com

Date Prepared: Oct. 30th 2020

II. DEVICE INFORMATION

Proprietary Name:	TaiChiC
Common/Usual Name:	Rotating Gamma System
Classification Name:	Radionuclide radiation therapy system
Device Regulation:	21 CFR 892.5750
Regulatory Class:	II
Product Code:	IWB

III. PREDICATE DEVICE

Primary Device	Akesis Galaxy RTx (K200050)
Classification Name:	Radionuclide radiation therapy system
Device Regulation:	21 CFR 892.5750
Regulatory Class:	II

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Product Code:	IWB
Reference Device	TaiChiA Medical Linear Accelerator (K193207)
Classification Name:	Medical charged-particle radiation therapy system
Device Regulation:	21 CFR 892.5050
Regulatory Class:	II
Product Code:	IYE

IV. Device Description:

v. Intended Use:

vi. Indications for Use:

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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

TaiChiC and predicate Akesis Galaxy RTx are both Radionuclide radiation therapy system. falling within 21 CFR 892.5750, product code IWB. The proposed TaiChiC is comparable to the predicate device with respect to the intended use, indications for use, technological characteristics and similar performance specifications.

The TaiChiC is also appropriately comparable to another device, TaiChiA Medical Linear Accelerator, cleared under 510(k) K193207. TaiChiA Medical Linear Accelerator is classified as a Medical charged-particle radiation therapy system, falling within 21 CFR 892.5050, product code IYE. This reference device is included as it is similar to TaiChiC with respect to indications for use, imaging techniques, gantry rotation, patient immobilization, couch and other features.

With regards to technological characteristics, the TaiChiC Rotating Gamma System, the predicate device and the reference device all have similar features and components. TaiChiC and the predicate device have same intended use, and both fall within the broader scope of the reference device. TaiChiC and Akesis Galaxy RTx both utilize Cobalt-60 radiation source to generate the treatment beam. All three systems have patient supporting system (couch) to support and position the patient during the treatment. All three systems have control consoles and interface software to control and monitor the systems. All three systems protect the operator and the general public from the radiation from the machine.

The main differences between TaiChiC and the predicate device include the number of sources used, the image guidance and the number of the collimator sets.

Comparing with the predicate device with 30 radioactive sources, TaiChiC has only 18 sources but with higher activities to provide a comparable dose rate at the focal spot, which is appropriate for the intended use.

The CBCT and kV-kV imaging techniques used in TaiChiC are similar as those in the reference device, while the predicate device does not provide this technique.

TaiChiC provides 7 sets of collimators with beam diameter at the focal spot of 6mm, 9mm, 12mm, 16mm, 20mm, 25mm and 35mm. While the predicate device provides 4 sets of collimators ¢ 4 mm, Φ 8 mm, Φ 14 mm and Φ 18 mm. The first four sets of TaiChiC collimators ( d 6mm, o 12mm, φ16mm) are comparable to those of the predicate device and all the collimators of TaiChiC fall within the broad beam collimating sizes of the reference device.

The above differences among the proposed device, the predicate and the reference device do not raise any safety and effectiveness issues.

The comparisons between the proposed TaiChiC Rotating Gamma System and the predicate device Akesis Galaxy RTx, the reference device TaiChiA Medical Linear Accelerator are provided in the table below.

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NO.	Feature	New Device	PredicateDevice(K200050)	Reference Device(K193207)	Analysis ofDifferences
1	ProductName	OUR TaiChiC RotatingGamma System.	Akesis Galaxy RTx	OUR TaiChiA MedicalLinearAccelerator
2	IntendedUse	TaiChiC is ateletherapy deviceintended to providestereotacticradiosurgery andprecision radiotherapyfor lesions, tumors, andconditions in the brainand head whereradiation treatment isindicated.	The Akesis GalaxyRTx system is ateletherapy deviceintended for thestereotacticirradiation of headstructures.	TaiChiA is a MedicalLinearAccelerator, intended toprovide stereotacticradiosurgery andprecision radiotherapy forlesions,tumors, and conditionsanywhere inthe body where radiationtreatmentis indicated.	The new device hassame intended useas the Predicatedevice,and has sameintended use as theReference devicefor treatment oflesions in the brainand head
3	Indicationsfor Use	ThiChiC is ateletherapy deviceintended to providestereotacticradiosurgery andprecision radiotherapyfor lesions, tumors, andconditions in the brain,and head, whereradiation treatment isindicated.	The Akesis GalaxyRTx system is ateletherapy deviceintended for thestereotacticirradiation of headstructures.	TaiChiA, is a MedicalLinear Accelerator,intended to providestereotactic radiosurgeryand precision radiotherapyfor lesions, tumors, andconditions anywhere inthe body where radiationtreatment is indicated.	The new device hassame intended useas the Predicatedevice,and has sameintended use as theReference devicefor treatment oflesions in the brainand head
4	Radiationsource	Cobalt 60	Cobalt 60	6MV X-ray	The new deviceradiation source isthe same with thePredicate Device
5	Initial Totalactivity	22860 Ci ±5%	6000 Ci ±10%	Treatment beam 6 MVnominal photon beamenergy.	The new devicetotal cobalt-60activity at loading ishigher than thePredicate Device,but the dose rate atthe focal spot is atthe same level.
6	Number ofradiationsources	18	30	Treatment beam 6 MVnominal photon beamenergy.	The radioactivesources of the newdevice have higheractivities, and soless radiationsources are neededcompared withPredicate device
		Initial Doserate at thefocal spot	$\textgreater 3.0Gy / min$	Up to 14 Gy / min	Radiation dose rateat focal spot atloading for the newdevice is verycomparable to thePredicate devicewhich isappropriate for theintended use.
8	Number ofcollimatorsizes(andnominalaperturesize)	7:$φ$ 6mm, $φ$ 9mm,$φ$ 12mm, $φ$ 16mm,$φ$ 20mm, $φ$ 25mmand $φ$ 35mm	4:$φ$ 4 mm, $φ$ 8 mm,$φ$ 14 mm, $φ$ 18 mm	NA	The new deviceutilizes 7 sets ofcollimator cones tocollimate theGamma rays, thecollimator sizes ofthe new devicecollimator sizes( $φ$ 6mm, $φ$ 9mm,$φ$ 12mm, $φ$ 16mm)are similar with thePredicate device.
9	Radiologicaccuracy	$\textless 0.5mm$	$\textless 0.5mm$	$\textless 1.0mm$	The new deviceradiologic accuracyis the same as thePredicate device
10	PatientCouch	Yes	Yes	Yes	All systems have apatient couch tosupport patientduring treatment.
11	Imagingtechniques	CBCT、kV-kV	NA	CBCT、kV-kV	The new deviceimaging techniquesis the same with theReference device.
12	Patientimmobilizationmethod	The Encompass™ SRS	Stereotactic HeadFrame andPositioning System	The Encompass™ SRSImmobilization System	The new devicelesion localizationfalls within therange of thepredicate, and sameas the referencedevice.

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V. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence:

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and electromagnetic compatibility (EMC) testing were conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Bench Test

Successful testing was performed in accordance with following standards:

IEC 60601-2-11: 2013, particular requirements for the basic safety and essential performance of gamma beam therapy equipment

IEC60601-1-3:2013, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic Xray equipment

IEC60601-2-68:2014, Medical electrical equipment - Part 2-68: particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

IEC61217:2011, Radiotherapy equipment - Coordinates, movements and scales

IEC62274 :2005, Medical electrical equipment - Safety of radiotherapy record and verify systems

IEC62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices

IEC60601-1-6:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

RT2:2017 Radiation therapy readiness check

ISO 15223-1: 2016. Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements

ISO10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Hardware and Software Verification and Validation Testing

Hardware and software verification and validation process were conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards.

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Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing 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.

Animal or clinical test

Not applicable for TaiChiC

Summary

The verification and validation testing demonstrated that TaiChiC has met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use.

VI. CONCLUSIONS

The TaiChiC has the same intended use, indications for use, fundamental scientific technology as the predicate device.

The difference among TaiChiC and predicate does not raise any new safety or effectiveness issues. The differences are substantial equivalent to the reference device

The Verification and Validation demonstrates that the device is as safe and effective as the predicate device.

Based on the comparison and analysis above, OUR therefore believes that TaiChiC is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5750 Radionuclide radiation therapy system.

(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.