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The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle.

The system supports a workflow based on automated image registration of spatial mapping from image space to physical space.

The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where is currently used for visualizing such procedures.

The system is not intended for guidance for the head, nervous system and central circulatory system (heart included).

The IMACTIS® CT-NAVIGATION system consists of a navigation station, specific software and a dedicated instrumentation set used in an interventional radiology room during percutaneous interventional radiological procedures performed under Computed Tomography.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance metric explicitly stated for the IMACTIS CT-NAVIGATION system is accuracy. The document compares this to the predicate device.

Conclusion: "IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device in terms of accuracy in rigid conditions." |
| Clinical Accuracy: Accuracy of the complete measurement chain on patients. Implied: Needs to provide sufficient guidance for interventional procedures. | Clinical Accuracy:
Median Accuracy (IMACTIS® CT-NAVIGATION system):

• Per Protocol: 3.8 mm [2.1; 9.9] (Median [P16%; P84%])
• Intention To Treat: 4.1 mm [2.1; 11.7] (Median [P16%; P84%])

Conclusion: "Regarding system registration performance of the predicate device, and the IMACTIS® CT-NAVIGATION system accuracy performance measured on the complete measurement chain, the IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device." |
| Electromagnetic Compatibility & Electrical Safety: Compliance with relevant standards. | Tested according to IEC 60601-1 and IEC 60601-1-2 standards. |
| Biocompatibility: Device components. | Tested according to ISO10993 standards. |
| Sterility: Sterilization of delivered components. | Tested according to ISO11737 and ISO11607 standards. |
| CT Imaging Requirements: Maintained performance across different CT resolutions. | Performance maintained for axial resolutions of 0.5mm/pixel (1mm slice spacing) and 1mm/pixel (2mm slice spacing). |

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

• Clinical Test Set Sample Size: 60 patients.
• Data Provenance: The study was a "clinical testing on patients," implying it was real-world patient data. The country of origin is not explicitly stated, but the manufacturer is based in France, suggesting the study might have been conducted there or in a nearby region. It is prospective in nature, as it collected data during interventions performed with the device.

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

The document does not explicitly state the number of experts used to establish a ground truth for the test set, nor their specific qualifications. The clinical study collected "system accuracy results" by physicians using the system for procedures. The reported accuracy metrics (median, P16%, P84%) suggest that the "ground truth" for the test was likely the actual achieved position during the intervention, which was then compared to the device's measurement. The "ground truth" wasn't established via expert consensus on imagery, but rather by the inherent precision of the physical measurements derived from the actual clinical use. The document does state the system is "intended for use by trained physicians in clinical intervention."

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. Given that the clinical study focused on measuring the system's accuracy during interventions, and not on interpreting images, an adjudication method in the traditional sense (for diagnostic studies) would not be applicable here. The "accuracy" itself is the outcome measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was mentioned. The device provides "intra-operative guidance" to trained physicians, but the study described is a performance/accuracy validation, not a study evaluating human reader performance with or without AI assistance. The device is the assistance in this context, guiding the needle.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The primary performance metric (accuracy) for the IMACTIS® CT-NAVIGATION system was evaluated for the system as a whole, including the localization system, calibration, and registration, and its use in clinical settings. This implies a standalone performance of the device's guidance capabilities output, which the physician then uses. The non-clinical testing performed on a "dedicated test bench" does represent a standalone evaluation of the system's inherent accuracy in a controlled environment, without a human actively making interpretive decisions based on the output.

7. The Type of Ground Truth Used

• Non-Clinical (Rigid conditions): The ground truth was established by comparing the device's measured position to the "known position of the cylindrical hole" on the dedicated test bench. This is an objective, physical measurement-based ground truth.
• Clinical: The "achieved accuracy" was collected for 60 patients. While not explicitly defined as a "ground truth" in the diagnostic sense, it refers to the accuracy of the device's guidance during actual procedures. This implies the ground truth for "accuracy" was the difference between the intended/known target and the actual achieved position after guidance by the system in a real clinical scenario.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This device is an image-guided navigation system, not an AI/machine learning diagnostic tool that requires a separate training set in the conventional sense for model development. Its software design is based on algorithms for image registration and spatial mapping.

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

As no training set is mentioned in the context of typical AI/ML model development, there's no information on how its ground truth would have been established. The device design and software were developed according to internal design control procedures, which would involve verification and validation against specified requirements.

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