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iGuide CAPPA is intended to be an intraoperative image-guided computer-assisted navigation system for minimally invasive interventions for interventional radiology. iGuide CAPPA can be used combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-arm systems.

It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account.

The device is intended to be used in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.

iGuide CAPPA is a navigation system that assists in the planning of different traiectories to selected targets and the navigated positioning of tools (e.g. biopsy needles, injection needles for vertebroplasty and kyphoplasty procedures) inside these targets. The navigation system can be used within the scope of interventional radiology.

Navigation System:
The navigation station consists of an industrial PC with an integrated touch-screen as user interface and specific navigation software. The PC is mounted on a mobile rack. For image acquisition the navigation system is connected to an imaging system (CT, MRT, C-Arm). A DICOM network application using the DICOM standard protocol provides the communication between the navigation system and the imaging system.

In order to track the navigation devices, an electromagnetic (EM) tracking system is used. This tracking system consists of a field generator producing an alternating electromagnetic field. The EM field induces voltage in the small coils implemented in the tips of the navigation devices. The voltage is measured by the EM tracking system and used to calculate the current position and orientation of the coil, thus determining the sensor's coordinates in five degrees of freedom (DoF).

The navigation hardware (PC, monitor, rack and tracking system) is combined to form NaviBase, a hardware and software platform for navigation applications.

Accessory Needles:
Electromagnetic needles with small coils embedded in their tips are used as navigation devices. For image-to-patient registration a reference plate (RP) is used. This plate makes it possible to map the patient image data to the actual physical data.

Motion Sensor:
Residual patient motion is monitored by an additionally tracked device (motion sensor) affixed to the patient's skin. The tracking system detects the motion sensor and sends its position relative to the RP to the navigation system. Patient motion is visualized on the monitor enabling the radiologist to recognize the motion and react accordingly.

The provided text is a 510(k) summary for the iGuide CAPPA device. It focuses on demonstrating substantial equivalence to a predicate device and includes information about the device's intended use and technical specifications. Crucially, the document does not contain explicit acceptance criteria or details of a study designed to prove the device meets specific performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions related to specific study details like sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

The document indicates that the 510(k) submission is primarily for the addition of a new accessory needle (Electromagnetic Tracking Needle Vertebroplasty) to an existing, previously cleared system (NaviStationIrad EMT, cleared by K080624). The main argument for substantial equivalence relies on the new needle being comparable to another marketed needle and the tracking system being identical to the one already cleared.

Here's what can be extracted from the provided text, and what cannot be:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The text does not mention specific acceptance criteria (e.g., accuracy thresholds, success rates) or present data on the device's performance against such criteria. The document is a regulatory submission for substantial equivalence, not a clinical trial report.

2. Sample sized used for the test set and the data provenance:

• Cannot be provided. No specific "test set" or a study with defined sample sizes is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be provided. Since no test set or study is detailed, there's no mention of experts establishing ground truth for such a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. No study or test set is described, so no adjudication method is mentioned.

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:

• Cannot be provided. The document describes a navigation system, not a typical diagnostic AI tool that would involve human readers interpreting images. No MRMC study is mentioned.

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

• Cannot be provided directly as a "standalone study." The device is an "image-guided computer-assisted navigation system" with a human in the loop (the radiologist). Therefore, a standalone algorithm-only study as understood for diagnostic AI is not applicable or described. The system's purpose is to assist, not to make decisions independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot be provided. No specific "ground truth" for a performance study is mentioned in this document.

8. The sample size for the training set:

• Cannot be provided. The document does not describe the development or training of an AI model in the sense of machine learning. It describes a navigation system that uses an electromagnetic tracking system and DICOM communication.

9. How the ground truth for the training set was established:

• Cannot be provided. As above, no training set for an AI model is described.

Summary of what can be extracted:

• Device Name: iGuide CAPPA
• Manufacturer: CAS innovations GmbH & Co. KG
• Intended Use: An intraoperative image guided computer assisted navigation system for minimally invasive interventions in interventional radiology. It assists in planning trajectories and navigating tools (e.g., biopsy needles, injection needles for vertebroplasty/kyphoplasty) using 3D-based imaging systems (CT, C-Arm).
• Predicate Device: NaviStationIrad EMT (K080624) from the same manufacturer.
• Reason for 510(k) submission: Addition of a new accessory needle (Electromagnetic Tracking Needle Vertebroplasty).
• Nature of the Device: A navigation station (PC, touch-screen, software) connected to imaging systems, using an electromagnetic (EM) tracking system for devices and a motion sensor for patient movement.
• Regulatory Basis: Substantial equivalence to the predicate device, especially regarding the tracking system and the new accessory needle's equivalence to existing needles.

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