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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 under 510(k) K151000. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.

This is a special submission for the addition of the following software features:

• Angular Annotation
• Easy Image Transfer
• Enhance Dynamic Range
• Cybersecurity Enhancements

These changes are only changes in software. There are no changes related to radiation performance. There are no changes to the device hardware required for these software changes. These features are described in more detail below and in the Device Description. This software also includes defect corrections.

The O-arm O2 Imaging System consists of two main assemblies that are used together:

• The Image Acquisition System (IAS)
• . The Mobile View Station (MVS)

The two units are interconnected by a single cable that provides power and signal data. The 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 O2 operates off standard line voltage within the following voltages:

• VAC 100, 120 or 240
• Frequency 60Hz or 50Hz
• . Power Requirements 1440 VA

This FDA 510(k) summary focuses on a software update (revision 4.1) for the Medtronic O-arm O2 Imaging System. The submission claims substantial equivalence to the previously cleared device and therefore does not include detailed clinical performance studies to establish new acceptance criteria. Instead, it relies on performance testing to demonstrate that the updated software does not negatively impact the device's intended performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define new acceptance criteria directly related to clinical performance metrics (like sensitivity, specificity, accuracy) for the new software features. Because this is a special 510(k) for software changes, the acceptance criteria are primarily focused on maintaining the safety and effectiveness of the previously cleared device. The "reported device performance" in this context refers to the successful completion of testing according to recognized standards, indicating that the device continues to perform as intended and its safety and effectiveness are not compromised by the software changes.

The performance testing conducted was against these standards to demonstrate that the product "will perform as intended according to the outlined design requirements."

• AAMI/ANSI ES 60601-1:2012 (Basic Safety & Essential Performance)
• IEC 60601-1-2:2007 (Electromagnetic Compatibility)
• IEC 60601-1-3:2008 (Radiation Protection)
• IEC 60601-2-28:2010 (X-ray Source Assemblies & Tube Assemblies Safety)
• IEC 60601-2-43:2010 (X-ray Equipment for Interventional Procedures)
• Risk / Hazard Analysis performed.
• Verification and/or validation activities performed based on Risk/Hazard Analysis with appropriate methods/tests and pass/fail criteria.

Conclusion: "The O-arm O2 Imaging system is similar in technological characteristics, imaging performance and indications for use as the predicate devices listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that 0-arm 02 Imaging System with 4.1 software does not raise new risks of safety and effectiveness when compared to the predicates." |
| Cybersecurity enhancements effectively address identified risks. | Cybersecurity Enhancements (removal of hardcoded passwords, added user authentication, software integrity check) performed within a Risk / Hazard Analysis framework. |
| New software features maintain the safety and effectiveness of the device as compared to the predicate. | Functional testing conducted to FDA recognized standards demonstrates no new risks of safety and effectiveness. |

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

This document does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic or clinical performance of the device's new software features on patient data. The "testing" mentioned refers to engineering and quality assurance tests against recognized standards. Therefore, specific details about sample size (e.g., number of patients/cases) for a clinical test set or data provenance (country, retrospective/prospective) are not provided as they are not relevant to this type of 510(k) submission.

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

Not applicable. As noted above, there was no clinical "test set" or ground truth established by experts for the performance evaluation described in this document. The evaluation focuses on engineering performance, safety, and functionality.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would typically be conducted to evaluate the impact of a device on human reader performance, which is not the focus of this software update notification.

6. Standalone Performance Study

The document does not describe a "standalone" performance study in the sense of evaluating the algorithm's performance on its own against a ground truth. The performance testing conducted was to verify that the upgraded system (hardware + new software) meets safety and performance standards for an imaging device.

7. Type of Ground Truth Used

Not applicable. For this special 510(k) submission focused on software updates, the "ground truth" refers to compliance with engineering standards and predefined design requirements, rather than clinical ground truth (e.g., pathology, expert consensus on images).

8. Sample Size for the Training Set

Not applicable. This document is a 510(k) submission for a software update to an existing medical imaging system. It does not describe the development of a new AI/machine learning algorithm that would require a dedicated training set. The software features added (Angular Annotation, Easy Image Transfer, Enhance Dynamic Range, Cybersecurity Enhancements) are functional improvements, not machine learning algorithms that are "trained" on data.

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

Not applicable, as there was no training set for a new AI/ML algorithm.

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