(125 days)
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.
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.
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:
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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.
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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.
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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.
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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).
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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).
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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.
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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.
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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.
§ 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.