(113 days)
The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
The O-arm® O2 Imaging System is compatible with certain image guided surgery systems.
The O-arm® O2 Imaging System is a mobile x-ray system that provides 3D imaging as well as 2D fluoroscopic imaging. It was originally cleared for market in 2005 via K050996. Additional submissions were made in 2006 (K060344) and 2009 (K092564). The device is classified under primary product code OWB (secondary OXO, JAA) , ref 21 CFR 892.1650.
O-arm® O2 Imaging System, also referred to as “O-arm® O2”, adds an extended field of view imaging mode that offers twice the lateral field of view as the prior design to provide clinicians further visualization options in larger anatomic regions and anatomical structures. It accomplishes this task with essentially the same hardware design as described within.
The system consists of two parts: the O-arm® Image Acquisition System (IAS), comprising of a x-ray generator, amorphous silicon flat panel x-ray detector and the x-ray control user interface and the Mobile View Station (MVS), comprising of the image processors, a user interface for image and patient handling and viewing monitor.
The O-arm® O2 Imaging System consists of two main assemblies that are used together during fluoroscopic imaging:
• The Mobile View Station (MVS)
• The Image Acquisition System (IAS)
The two units are interconnected by a single cable that provides power and signal data. The O-arm® IAS has an internal battery pack that provides power for motorized transportation and gantry positioning. In addition the battery pack is used to power the X-ray tank. The MVS has an internal UPS to support its function when mains power is disconnected.
The O-arm® operates off standard line voltage within the following voltages:
• VAC 100, 120 or 240
• Frequency 60Hz; 50Hz
• Power Requirements 1440 VA
The provided text describes the O-arm® O2 Imaging System and its substantial equivalence to a predicate device, the O-arm® 1000. The information given does not detail specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) that would typically be presented for an AI/ML device, nor does it describe a study specifically designed to prove the device meets such criteria in the context of an AI/ML product.
Instead, the document details performance testing related to electrical safety, electromagnetic compatibility, radiation protection, and software/hardware verification, which are standard for medical imaging devices. It also mentions an "Image Quality Assessment" and a "Cadaver Image Pair Study" for comparison with the predicate device, but without specific acceptance criteria or detailed results of those studies in terms of quantitative performance metrics.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not discernible from the provided text, as the submission appears to focus on demonstrating substantial equivalence to a predicate device through engineering and safety testing rather than a clinical performance study with specific AI-related metrics.
Here is the information that can be extracted or reasonably inferred from the provided text, formatted as requested where possible:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are largely related to compliance with electrical, safety, radiological, and software/hardware engineering standards, and demonstrating image quality comparable to the predicate device. Specific quantitative performance metrics with defined acceptance thresholds (e.g., for diagnostic accuracy, sensitivity, specificity) are not explicitly stated in the provided document. The device performance is generally reported as "will perform as intended" or "meets all prescribed design inputs" through compliance testing and comparative studies.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Compliant with AAMI/ANSI ES 60601-1:2012 |
| Electromagnetic Compatibility | Compliant with IEC 60601-1-2:2007 |
| Radiation Protection | Compliant with IEC 60601-1-3:2008, IEC 60601-2-28:2010, IEC 60601-2-43:2010 |
| Software Verification | Verification and Validation testing confirmed software perform as intended |
| Hardware Verification | Hardware requirements identified for the system perform as intended |
| Image Quality Assessment | Quantitative image quality assessment in comparison to the predicate O-arm® 1000 device was conducted. (Specific results/metrics not provided) |
| Dosimetry | Dosimetry measurements for various modes documented. (Specific results/metrics not provided) |
| Usability | Usability Testing conducted according to FDA guidance. Users conducted imaging functions under simulated use conditions. |
| Clinical Utility | O-arm® Cadaver Image Pair Study evaluated clinical utility compared to predicate O-arm® 1000 and reference Artis Zeego device. (Specific results/metrics not provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- The "O-arm® Cadaver Image Pair Study" is mentioned, which implies a test set of cadaver images. However, the specific sample size (number of cadavers or images) for this study is not provided.
- For other engineering and safety tests, the "test set" would refer to the device itself or components under various test conditions, not patient data.
- Data Provenance:
- The "O-arm® Cadaver Image Pair Study" used cadaver images. Further details on the origin (e.g., country) or whether they were retrospective/prospective are not provided.
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)
This information is not provided in the document. The text does not describe a process for establishing ground truth, especially not with expert readers, for the comparative image quality or clinical utility studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study, particularly in the context of human readers improving with AI assistance, is not described in the document. The "O-arm® Cadaver Image Pair Study" is a comparative study of the device's images against a predicate and reference, not a study of human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an imaging system (hardware and associated software for image acquisition and reconstruction), not a standalone AI algorithm for interpretation. Therefore, a "standalone" AI algorithm performance study as typically understood is not applicable in this context. The closest would be the "Image Quality Assessment," which directly evaluates the system's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for any of its comparative or image quality studies. For an "Image Quality Assessment," the ground truth might be based on physical phantoms with known properties or established image quality metrics. For the "Cadaver Image Pair Study," the ground truth for "clinical utility" would likely refer to the ability to visualize specific anatomical structures or metallic objects, but how this was objectively established is not detailed.
8. The sample size for the training set
The device described is an imaging system (hardware and software) that performs 2D fluoroscopic and 3D imaging and image reconstruction. It is not presented as a machine learning inference algorithm that would typically undergo a "training" phase with a large dataset. Therefore, a "training set sample size" is not applicable in the context of this device description.
9. How the ground truth for the training set was established
As the device is an imaging system and not explicitly described as an AI/ML inference algorithm, the concept of a "training set" and its "ground truth" establishment is not applicable from the provided text.
§ 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.