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The iSYS 1 device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or electrode where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the iSYS device.

The iSYS 1 is a modular needle guidance platform for interventional radiology and related fields. Core components are a 4 DOF micro positioning unit which allows the submillimetric needle positioning from simple needle angulations up to positioning and angulations with adjustable pivot point and a control unit which is directed by a cable connected control panel. The passive macro positioning unit and different table adapters allow different setups of the system around the patient in the region of interest. The needle-guide-kit (manufactured by ECOLAB) provides disposable components that ensure precise and sterile needle guidance.

Planning of the tool position/orientation as well as validation of the correctness of the tool position must be performed with an external planning and measurement system which is not part of the iSYS-1 Interventional Platform. The position of iSYS 1 is visible for most imaging systems due to the used markers. During treatment the tool is controlled by the user.

The iSYS 1 device is a user-controlled electromechanical arm with a needle guide intended to assist surgeons in positioning a needle or electrode using CT and fluoroscopic imaging for trajectory planning and intraoperative tracking.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates general performance aspects that were tested and confirmed. Based on the "Performance Data" and "Non-Clinical Performance Data" sections, the implied acceptance criterion is that the device demonstrates mechanical accuracy, compatibility, stability, and proper functionality within specified operating conditions.

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

The document does not specify a separate "test set" in the context of clinical or image-based evaluations with patient data. The performance studies mentioned appear to be more focused on non-clinical, bench-top testing to verify mechanical and electrical characteristics.

• Sample Size: Not specified for any clinical or image-based test set involving patients. The performance tests refer to "clinical conditions" for accuracy of needle placement, but no sample size or patient count is given.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The tests focus on device performance rather than patient outcomes from a specific country. The manufacturer is iSYS Medizintechnik GmbH from Austria.

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

This information is not provided. The ground truth for performance tests appears to be based on engineering measurements and validation against known standards (e.g., accuracy below 1mm, compliance with electrical safety standards). For "accuracy of the needle placement under clinical conditions," it's not specified how ground truth was established or by whom.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set requiring expert adjudication for ground truth is not detailed in the provided information.

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

Not applicable. The iSYS 1 is a mechanical device for needle guidance, not an AI or image interpretation system for "human readers." Therefore, an MRMC study comparing human readers with and without AI assistance is outside the scope of this device's evaluation as described.

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

Not applicable. The iSYS 1 is an electromechanical arm designed to assist a surgeon (human-in-the-loop). It is not an algorithm-only device. The planning of the tool position/orientation and validation of its correctness are performed with external planning and measurement systems, and the needle/electrode is manually advanced by the surgeon.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data, the ground truth is primarily engineering specifications, physical measurements (e.g., mechanical accuracy below 1mm), and adherence to established electrical and mechanical safety standards (EN ISO 60601-1, EN 60601-1-8) and EMC standards (FCC Part15, ISO 60601-1-2). For "accuracy of the needle placement under clinical conditions," the specific type of ground truth (e.g., imaging confirmation, direct measurement) is not detailed.

8. The Sample Size for the Training Set

Not applicable. The iSYS 1 device is a mechanical system, not an AI or machine learning algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this device.

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