(28 days)
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of instruments during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning based on CT images and is intended to assist the physician in positioning of an instrument, such as a needle, and reviewing instrument position during advancement to the target. The system quides (i.e., positions and steers) the instrument according to a predefined trajectory. The physician controls advancement of the instrument along the trajectory using a foot pedal. The system also allows for monitoring of motion associated with respiration during the procedure.
The XACT ACE Robotic System comprises the following main components:
- XACT ACE Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
- XACT ACE Console which includes a Control Unit, central computer (in the Control Unit) and monitor workstation for user trajectory planning, user interface and review of instrument position.
The XACT ACE Robotic System is a modification of a previously cleared device (XACT Robotic System, ACE Model K201586) to expand the list of supported instruments to include ablation probes. The performance data provided focuses on verifying the compatibility and accuracy of the device when used with these new ablation probes.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document does not explicitly present a table of acceptance criteria with numerical thresholds. Instead, it describes the verification and validation process in terms of meeting performance specifications and demonstrating similar performance characteristics to biopsy introducers. Based on the provided text, the key performance aspects evaluated were:
| Acceptance Criteria (Inferred from study description) | Reported Device Performance |
|---|---|
| Efficiently secures ablation probes. | Instrument Insertion Kit efficiently secures the probes. |
| Advances probes to target without physical damage. | Probes advance to target without any physical damage. |
| Robotic system configured for physical characteristics of probes. | All relevant physical characteristics were adequately measured and configured in the robotic system. |
| Meets performance specifications for steering to targets. | Steering to targets met performance specifications. |
| Meets target accuracy (tip-to-target average accuracy) comparable to biopsy introducers in a simulated clinical environment. | Device meets all of its performance characteristics, with similar performance characteristics (tip-to-target average accuracy) compared to biopsy introducers. |
| No changes to clinical workflow. | Demonstrated no changes to the clinical workflow. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the "Needle Properties" protocol: The document states "each probe" was measured, implying a sample size of 4 ablation probes (corresponding to the four types of ablation probes introduced).
- For the simulated clinical environment test: The document mentions steering "each of the probes to a variety of targets" and "steers the compatible listed ablation probes to a variety of targets." It doesn't specify an exact number of procedures or targets, but it implies a comprehensive evaluation across different scenarios for each of the 4 probe types.
- Data Provenance: The studies were conducted internally as part of the device's verification and validation. The studies were performed in a simulated clinical environment (CT suite using a specific phantom), indicating a controlled, prospective experimental setup rather than retrospective use of human patient data. No country of origin for the data is explicitly mentioned beyond the submitter's address in Israel.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. The ground truth for the simulated clinical environment test appears to be defined by the pre-planned "variety of targets" within the phantom. The evaluation of performance and meeting specifications would likely be overseen by engineers and potentially clinical specialists involved in the test.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The evaluation seems to rely on direct measurements and observations during the automated and user-controlled robotic procedures in the simulated environment, with the system's ability to reach predefined targets being the primary metric.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The study described focuses on the device's performance with new instruments rather than comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The studies described are for a user-controlled positioning system, and the "user advances the instrument along the trajectory using a foot pedal." While the robot autonomously steers, the overall procedure involves human input and control. The performance tests were conducted to demonstrate the robot's ability to steer and position instruments in conjunction with human control and CT imaging for planning and tracking, which is not a purely standalone algorithm-only performance assessment.
7. Type of Ground Truth Used
The ground truth used for the test set was based on predefined targets within a specific phantom in a simulated clinical environment. This is a form of objective physical ground truth established through the experimental setup rather than expert consensus, pathology, or outcomes data from human patients.
8. Sample Size for the Training Set
The document does not mention any separate training set or machine learning aspects for the expanded functionality. The system's operation appears to be based on pre-programmed algorithms and physical characteristics of the instruments, not on a machine learning model that would require a dedicated training set. The modifications involve supporting new instruments, which primarily required physical characterization and integration.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in relation to the new functionality, this point is not applicable.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.