The Orthoscan TAU Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

Device Description

The proposed modifications to Orthoscan TAU Mini C-Arm system models 1000-0015, 1000-0016, 1000-0017 retain identical function as the predicate Orthoscan TAU Mini C-arm (K213113) and the Orthoscan VERSA Mini C-arm (K243452) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees and hips. The system consists of C-arm support attached to the image workstation.

The changes to the Orthoscan TAU Mini C-Arm X-ray system models 1000-0015, 1000-0016, 1000-0017 represent a modification of our presently legally marketed devices Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA Mini C-arm (K243452). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04, revisions to generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead, update to wireless footswitch communication protocol, an alternate detector for Orthoscan TAU Mini C-arm model 1000-0017 and the introduction of an optional 32in. display monitor.

The proposed device replicates the features and functions of the predicate devices without impacting image clarity or dose levels.

For both the predicate TAU (K213113) and proposed device, the following are unchanged; C-arm support of flat panel detector, generator and x-ray controls, mechanical connections, balancing, locking, rotations, work-station platform, main user interface controls, touch screen interface, selectable imaging, X-ray technique control, entry of patient information, wired footswitch operation, interface connection panel and DICOM fixed wire and wireless network interfaces.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Orthoscan TAU Mini C-Arm details a modification to an existing device rather than a new device with novel performance claims. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on demonstrating substantial equivalence to existing predicate devices, particularly in terms of image quality and safety, rather than establishing absolute performance metrics for a completely new clinical claim.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate devices (Orthoscan TAU Mini C-Arm K213113 and Orthoscan VERSA Mini C-arm K243452) in terms of image quality, safety, and functionality, despite the implemented modifications.

Since this is a modification to an existing fluoroscopic X-ray system, the "performance" is assessed relative to the predicate, with the aim of ensuring no degradation, and ideally, slight improvement in certain aspects. The document doesn't provide a table of precise quantitative acceptance criteria for image quality metrics (e.g., spatial resolution in lp/mm, contrast-to-noise ratio) because the primary goal was comparative equivalence, not meeting predefined numerical thresholds for a new claim.

However, the reported device performance, relative to the predicate, is implicitly stated:

Acceptance Criterion (Implicit)	Reported Device Performance (Relative to Predicate)
Image Quality Equivalence/Improvement	"His conclusion was that the image quality at same or similar patient dose rates will result in equivalent or slight improvement in patient care (images) for the proposed modified TAU device over the predicate device.""Image quality acquired using the proposed alternate detector was of equal or slightly improved image quality..."
Dose Rate Equivalence	"the image quality at same or similar patient dose rates...""maintaining or improving image at same or similar dose..."
Safety (Radiation, Mechanical, Electrical, Cybersecurity)	"The proposed modified Orthoscan TAU Mini C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management and controlled by meeting the applicable CDRH 21 CFR subchapter J performance requirements, Recognized Consensus Standards, designing and manufacturing under Ziehm-Orthoscan, Inc. Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.""...cybersecurity controls are improved..."Certified compliant with 60601-1 ED 3.2 series, including IEC 60601-2-54, well as IEC 62304:2006 + A1:2015 Medical device software – Software life cycle processes. Met all applicable sections of 21 CFR Subchapter J performance standards. Software and cybersecurity testing performed to meet requirements from FDA guidances "Content of Premarket Submissions for Device Software Functions" (2023) and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (2023).
Functionality Equivalence	"The proposed device replicates the features and functions of the predicate devices without impacting image clarity or dose levels.""For both the predicate TAU (K213113) and proposed device, the following are unchanged; C-arm support of flat panel detector, generator and x-ray controls, mechanical connections, balancing, locking, rotations, work-station platform, main user interface controls, touch screen interface, selectable imaging, X-ray technique control, entry of patient information, wired footswitch operation, interface connection panel and DICOM fixed wire and wireless network interfaces."

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical "sample size" in terms of number of unique phantoms or individual images. It states "Numerous image comparison sets were taken" and "Images collected included phantom motion that was representative of typical clinical use". For the alternate detector evaluation, "Images collected included phantom motion... These images were reviewed by a Certified Radiologist who confirmed that the image quality acquired using the proposed alternate detector was of equal or slightly improved image quality...".
- Data Provenance: The data was generated through "Non-clinical image and dose lab testing" and "bench testing". This implies controlled laboratory conditions, not patient data. Country of origin for data generation is not explicitly stated but can be inferred as likely being in the US, given the US-based company and FDA submission. The study was inherently prospective in that new images were generated for the purpose of the comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a Radiologist" (singular) performed an assessment of individual images.
- Qualifications of Experts: "Certified Radiologist". No further details on years of experience are provided, but "Certified" implies meeting professional board certification standards.
Adjudication method for the test set:
- The document states "a Radiologist performed an assessment of individual images arranged in groups of image sets." There is no mention of an adjudication method involving multiple readers, as only a single radiologist was used for the image quality assessment.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. The document explicitly states: "Orthoscan TAU Mini C-arm system did not require live human clinical studies to support substantial equivalence...". The image quality assessment was performed by a single certified radiologist using phantom images. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported, as AI assistance is not the subject of this 510(k) (it's a hardware/OS/component modification, not an AI diagnostic tool).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the context of this 510(k). The device is an imaging system (C-arm), not an AI algorithm that performs standalone diagnoses. Its performance is assessed in terms of image generation quality, which is then interpreted by a human user (physician).
The type of ground truth used:
- The "ground truth" for the image quality comparison was established by expert assessment (a Certified Radiologist's qualitative judgment) of images generated from anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms. This is considered a "phantom-based" ground truth, which is a common approach for demonstrating equivalence in imaging system modifications where clinical studies are not deemed necessary.
The sample size for the training set:
- Not applicable. The document describes modifications to an existing fluoroscopic X-ray system, including an OS upgrade and hardware changes. There is no indication of a machine learning or AI component that would require a "training set" in the conventional sense of data used to train an algorithm. The development involved risk analysis, design reviews, component testing, integration testing, performance testing, safety testing, and product use testing of the system itself.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI algorithm in this context.

Summary

FDA 510(k) Clearance Letter - Orthoscan TAU Mini C-Arm

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U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

July 2, 2025

Ziehm-Orthoscan, Inc.
℅ Kevin Bridgman
VP of Regulatory Affairs and Quality Assurance
14555 N. 82nd St.
SCOTTSDALE, AZ 85260

Re: K250587
Trade/Device Name: Orthoscan TAU Mini C-Arm
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OXO, JAA, MQB
Dated: June 5, 2025
Received: June 5, 2025

Dear Kevin Bridgman:

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.

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K250587 - Kevin Bridgman Page 2

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 (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250587 - Kevin Bridgman Page 3

assistance/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,

Lu Jiang

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K250587

Device Name
Orthoscan TAU Mini C-Arm

Indications for Use (Describe)
The Orthoscan TAU Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

510(k) Premarket Notification Submission- Ziehm-Orthoscan, Inc. TAU Mini C-Arm

Submitter: Ziehm-Orthoscan, Inc.
14555 N 82nd St.
Scottsdale, AZ 85260
Phone: (480) 503-8010
Fax: (480) 503-8011
Primary Contact: Kevin Bridgman; Kevin.bridgman@ziehm-orthoscan.com
Secondary Contact: TuAnh Ngo; tuanh.ngo@ziehm-orthoscan.com
Date: June 30, 2025

In accordance with the requirements of 21 CFR 807.92 the following 510(k) summary of information is provided:

Device Trade Name: Orthoscan TAU Mini C-Arm
510(k) Number: K250587
Common/Usual Names: Fluoroscopic X-Ray System, Mobile Mini Mobile C-arm, Mini C-arm
Regulation: 21 CFR 892.1650
Device Class: Class II
Regulation Names: Image-intensified fluoroscopic x-ray system
Device: Image-intensified fluoroscopic x-ray system, mobile
Product Codes: OXO, JAA, MQB

Primary Predicate: Orthoscan TAU Mini C-Arm
510(k) Number: K213113
Regulation: 21 CFR 892.1650
Device Class: Class II
Regulation Names: Image-intensified fluoroscopic x-ray system
Product Code: OXO, JAA, MQB

Secondary Predicate: Orthoscan VERSA TAU Mini C-Arm
510(k) Number: K243452
Regulation: 21 CFR 892.1650
Device Class: Class II
Regulation Names: Image-intensified fluoroscopic x-ray system
Product Code: OXO, JAA, MQB

General Description:

The proposed modifications to Orthoscan TAU Mini C-Arm system models 1000-0015, 1000-0016, 1000-0017 retain identical function as the predicate Orthoscan TAU Mini C-Arm (K213113) and the Orthoscan VERSA Mini C-arm (K243452) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees and hips. The system consists of C-arm support attached to the image workstation.

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The proposed device replicates the features and functions of the predicate devices without impacting image clarity or dose levels.

Indications for Use:

The Orthoscan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

Indications for Use Comparison:

The proposed modifications to Orthoscan TAU Mini C-Arm series do not change the indications for use. The indications for use are the same as the predicate device Orthoscan TAU (K213113) Mini C-Arms.

Technology:

The changes to the proposed device Orthoscan TAU Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA (K243452). With the introduction of a Linux based operating system (OS) upgrade from Ubuntu 16.04 to Ubuntu 20.04, an open source highly secure OS, cybersecurity controls are improved, image quality is maintained or improved, and capability is created for future expansions of the proposed Orthoscan TAU device models. Revisions to generator printed circuit board improve power management efficiency and implementation of an alternate generator radiation shielding material reduces environmental impact of lead. Updating the communication protocol of wireless footswitch from fixed pairing method to code-hopping method maintains state of the art wireless communications and perpetuates free operator movement with fewer cables in the way. Alternate detector(s) for the 1000-0017 to establish an alternate detector supply chain source for Orthoscan TAU model 1000-0017 while maintaining or improving image at same or similar dose, and the addition of an optional 32in. monitor screen provides a larger displayed image.

Summary of Technological Characteristics:

The comparisons of the proposed modifications to Ziehm-Orthoscan, Inc. TAU Mini C-Arm demonstrate that the scientific and technology characteristics indicate substantial equivalence to the predicate device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA Mini C-arm (K243452).

Adverse Effects on Health:

The proposed modified Orthoscan TAU Mini C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management and controlled by meeting the applicable CDRH 21 CFR subchapter J performance requirements, Recognized Consensus Standards, designing and manufacturing under Ziehm-Orthoscan, Inc. Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.

Non-Clinical Testing Summary:

Verification and Validation including hazard mitigations executed resulted in demonstrated system that met Design Input and user needs. The device was tested by certified test laboratory resulting in device being certified compliant with 60601-1 ED 3.2 series, including IEC 60601-2-54, well as IEC 62304:2006 + A1:2015 Medical device software – Software life cycle processes. Further, the device met all applicable

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sections of 21 CFR Subchapter J performance standards. Additionally, software and cybersecurity testing were performed to meet requirements from the FDA guidances "Content of Premarket Submissions for Device Software Functions" (2023) and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (2023), as well as all other applicable software and cybersecurity guidances and regulations. The proposed modified Orthoscan TAU Mini C-Arm development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to;

Risk Analysis
Required reviews
Design reviews
Component testing
Integration testing
Performance testing
Safety testing
Product use testing

Performance bench testing included non-clinical testing methods specific to guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); demonstrating system, and imaging performance. Non-clinical image and dose lab testing were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed, images were taken by both the proposed TAU and the predicate device Orthoscan TAU (K213113). Numerous image comparison sets were taken, and a Radiologist performed an assessment of individual images arranged in groups of image sets. His conclusion was that the image quality at same or similar patient dose rates will result in equivalent or slight improvement in patient care (images) for the proposed modified TAU device over the predicate device. Therefore, Ziehm-Orthoscan, Inc. believes the proposed Orthoscan TAU Mini C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Orthoscan TAU (K213113) and Orthoscan VERSA Mini C-arm (K243452).

Summary of Clinical Test Data:

Orthoscan TAU Mini C-arm system did not require live human clinical studies to support substantial equivalence in accordance with the related guidance documents, Premarket Assessment of Pediatric Medical Devices May 24, 2014 and Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017.

Therefore, Ziehm-Orthoscan, Inc. conducted a lab test image comparison study employing the use of anthropomorphic phantoms in establishing substantial equivalence based on the modifications to the proposed device and the bench data taken in comparison to the predicate Orthoscan TAU Mini C-Arm (K213113) and VERSA (K243452). Images collected included phantom motion that was representative of typical clinical use, as judged by a Certified Radiologist.

Image quality comparisons representative of diagnostic, surgical, and critical emergency care procedures were collected. These images were reviewed by a Certified Radiologist who confirmed that the image quality acquired using the proposed alternate detector was of equal or slightly improved image quality, and that the images evaluated represented typical clinical use and fulfill the requirements stated by the intended use of the device.

Substantial Equivalence Conclusion:

The changes and differences of the proposed Orthoscan TAU Mini C-Arm described do not change the control mechanism, operating principle, energy type, or intended use found on the predicate device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA Mini C-arm (K243452).

Ziehm-Orthoscan, Inc. considers the proposed modified Orthoscan TAU Mini C-arm to be as safe, as effective, and performs substantially equivalent to the predicate device Orthoscan TAU Mini C-arm (K213113) and Orthoscan VERSA Mini C-arm (K243452) in accordance with its labeling.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.