The Z-Robot™ Patient Positioning System is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.

Device Description

The Z-Robot™ Patient Positioning System (hereinafter referred to as Z-Robot™) is an electro-mechanical robotic arm with the motion capability in six degrees of freedom. These axes allow the couch to be precisely positioned translationally and rotationally within the specified movement limits. Therefore, Z-Robot™ could be used to accurately position patient in radiotherapy and medical imaging.

AI/ML Overview

The requested information is contained within the provided text. The device in question is the "Z-Robot™ Patient Positioning System", which is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a "table of acceptance criteria and reported device performance" for all tests. However, it lists the performance parameters tested and indicates that "All test results were acceptable per the acceptance criteria detailed in the corresponding protocol and test report." It also provides a direct comparison to the predicate device for several key performance metrics, implying these are the relevant acceptance criteria for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implied by Predicate & "Same")	Reported Device Performance (Z-Robot™ Patient Positioning System)
Accuracy	± 0.5 mm and ± 0.2°	± 0.5 mm and ± 0.2° (Same as predicate)
Linear XYZ maximal medical speed	10 cm/s	10 cm/s (Same as predicate)
Linear XYZ maximum maintenance speed	20 cm/s	20 cm/s (Same as predicate)
Angular Yaw Pitch Roll maximum medical speed	5 °/s	5 °/s (Same as predicate)
Angular Yaw Pitch Roll maximum maintenance speed	12 °/s	12 °/s (Same as predicate)
Collision detection	Detection of a 150 N force	Detection of a 150 N force (Same as predicate)
"Overtravel" in case of emergency stop	<5 mm	<5 mm (Same as predicate)
Speed Accuracy	(Not explicitly detailed, but stated "acceptable")	"All test results were acceptable"
Translational Accuracy	(Not explicitly detailed, but stated "acceptable")	"All test results were acceptable"
Rotational Accuracy	(Not explicitly detailed, but stated "acceptable")	"All test results were acceptable"
Repeatability	(Not explicitly detailed, but stated "acceptable")	"All test results were acceptable"

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

The document states that "A series of safety and performance tests were conducted on the subject device, Z-Robot™ Patient Positioning System." It does not specify the sample size for these tests (e.g., number of devices tested or number of times each test was performed). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing of the manufactured device.

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

This information is not applicable and not provided. The testing described is non-clinical performance testing of a physical device, not a diagnostic or AI-based system requiring expert interpretation or ground truth establishment in the typical sense. The "ground truth" for these tests would be the physical measurements taken during the performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the testing is non-clinical performance testing, there's no "adjudication method" in the context of expert review or consensus as there would be for an image classification or diagnostic device.

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 MRMC study was done. The device is a patient positioning system, not an AI-assisted diagnostic or imaging interpretation tool that would typically involve human readers.

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

The device itself is a mechanical system, not an algorithm in the sense of AI. The performance tests ("Reliability test," "Software Validation test," "Electromagnetic compatibility and electrical safety test," and "Performance test") evaluate the standalone performance of the Z-Robot™ Patient Positioning System, as it is a machine.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance tests would be precise measurements obtained through calibrated instruments and established engineering standards. For example, for "Accuracy (± 0.5 mm and ± 0.2°)", the ground truth would be the actual position and orientation measured by high-precision sensors, compared against the commanded movements. This is a form of empirical measurement against a known standard.

8. The Sample Size for the Training Set

This information is not applicable. The Z-Robot™ Patient Positioning System is a mechanical device, not an AI or machine learning model that requires a "training set."

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

This information is not applicable, as there is no "training set" for this device.

Summary

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Image /page/0/Picture/0 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.

Chinan Biomedical Technology, Inc. % Mr. James Chinan Chen CEO 6F., No.16, Sec.2 ,Shengyi Rd., Zhubei City Hsinchu County, 302 TAIWAN (R.O.C)

June 27, 2019

Re: K182683

Trade/Device Name: Z-Robot™ Patient Positioning System Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: Class II Product Code: JAI Dated: May 10, 2019 Received: May 20, 2019

Dear Mr. Chen:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 mediation-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 Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Section 4 - Indications for Use Statement

Section 4

Indications for Use Statement

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Z-Robot™ Patient Positioning System

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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Section 5 - 510 (k) Summary

Section 5

510(k) Summary

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Traditional 510(k) Section 5 - 510 (k) Summary K182683

510(k) SUMMARY

5.1. Type of Submission:	Traditional
5.2. Date of Summary:	Sep. 25, 2018
5.3. Submitter:	Chinan Biomedical Technology, Inc.
Address:	6F., No.16, Sec. 2, Shengyi Rd., Zhubei City,Hsinchu County 302, Taiwan (R.O.C.)
Phone:	+886-3-5509118
Contact:	James Chinan Chen (chinan777@gmail.com)

5.4. Identification of the Device: Z-Robot™ Patient Positioning System Proprietary/Trade name: Model Name: Z-KR360 Classification Product Code: JAI Regulation Number: 892.5770 Regulation Description: Powered radiation therapy patient support assembly Review Panel: Radiology II Device Class:

ર.ડ. Identification of the Predicate Device:

Predicate Device Name:	LEONI Orion System
Manufacturer:	LEONI CIA Cable Systems SAS
Classification Product Code:	JAI
Regulation number:	892.5770
Device Class:	II
510(k) Number:	K160518

5.6. Intended use

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5.7. Device description

5.8. Non-clinical testing

A series of safety and performance tests were conducted on the subject device, Z-Robot™ Patient Positioning System.

Reliability test
· Software Validation test
· Electromagnetic compatibility and electrical safety test The Z-Robot™ Patient Positioning System complies with IEC 60601-1 standard
- for safety.
· Performance test

To ensure proper performance in this application, the design input requirements direct that the final products must demonstrate the following properties:

Speed Accuracy
Translational Accuracy -
Rotational Accuracy
-Repeatability

All test results were acceptable per the acceptance criteria detailed in the corresponding protocol and test report.

5.9. Clinical testing

No clinical test data was used to support the decision of substantial equivalence.

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Item	Subject device	Predicate device	Substantiallyequivalence
Proprietary Name	Z-Robot™ Patient PositioningSystem	LEONI Orion System	-
Model Name	Z-KR360	-	-
510(k) No.	-	K160518	-
Intended Use	The Z-Robot™ PatientPositioning System is anelectro-mechanical robotic armfor patient positioning inradiotherapy and medicalimaging. It is designed forpositioning a patient with a highdegree of accuracy andrepeatability.	The LBONI Orion System is anelectro-mechanical robotic armfor patient positioning inradiotherapy and medicalimaging. It is designed forpositioning a patient with a highdegree of accuracy andrepeatability.	Same
Type of use	Prescription Use	Prescription Use	Same
Payload	Rated payload of the robotic arm :360 kgMaximum patient weight: 180 kg	375 kg	Differen1
Accurate treatment volume	400×1,000×500 mm	400×1,000×500 mm	Same
Accuracy	± 0.5 mm and ± 0.2°	± 0.5 mm and ± 0.2°	Same
Speed	• Linear XYZ maximal medicalspeed: 10 cm/s• Linear XYZ maximummaintenance speed: 20 cm/s• Angular Yaw Pitch Rollmaximum medical speed: 5 °/s• Angular Yaw Pitch Rollmaximum maintenance speed:12 °/s	• Linear XYZ maximal medicalspeed: 10 cm/s• Linear XYZ maximummaintenance speed: 20 cm/s• Angular Yaw Pitch Rollmaximum medical speed: 5 °/s• Angular Yaw Pitch Rollmaximum maintenance speed:12 °/s	Same
Item	Subject device	Predicate device	Substantiallyequivalence
Safety
Collision detection	Detection of a 150 N force	Detection of a 150 N force	Same
"Overtravel" in case ofemergency stop	<5 mm	<5 mm	Same

5.10. Substantial equivalence determination

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Different' : Different but does not impact safety and effectiveness of subject device

5.11. Similarity and difference

The subject device has same intended use and similar performance as the predicate device. And the difference between the subject device and the predicate device is the payload. The subject device has undergone performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use and performance claims.

5.12. Conclusion

After analyzing bench tests, device description and intended use, it can be concluded that the Z-Robot™ Patient Positioning System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5770 Powered radiation therapy patient support assembly.

(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.