(140 days)
The XACT 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 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 Robotic System comprises the following main components:
- . XACT Robot Positioning Unit & Insertion Module Assembly which is placed on the patient
- XACT Control Unit (Central Computer) .
- . XACT Computer Work Station which includes the user interface for trajectory planning and review of instrument position
- XACT System Cart ●
The provided text describes the XACT Robotic System, a user-controlled positioning system intended to assist in CT-guided percutaneous procedures. While the document outlines several performance tests and mentions preliminary clinical data, it does not explicitly define acceptance criteria as a table with numerical targets, nor does it detail a comparative effectiveness study (MRMC) or a standalone AI algorithm. It provides some performance figures from pre-clinical and preliminary clinical studies.
Here's an attempt to extract the information based on the provided text, acknowledging the limitations regarding the completeness of "acceptance criteria" as you might expect in a formal table with specific thresholds:
1. A table of acceptance criteria and the reported device performance
The document doesn't present "acceptance criteria" in a formal table with specific numerical thresholds for each test. Instead, it describes performance tests and their outcomes.
| Performance Test Category | Reported Device Performance (Proxy for Acceptance) |
|---|---|
| Pre-clinical Animal Study (Porcine Model) | - Target Reach: System reached the target in all 40 interventional procedures. |
| - Average Accuracy: 1.41mm ± 0.94mm (Distance from target). | |
| - Adverse Events: No adverse events reported specific to the system (implied by "demonstrate the safety and effectiveness"). | |
| Preliminary Clinical Data | - Target Reach/Success Rate: Device successfully reached the target in 27 out of 31 cases (87.1%). |
| - Procedure Completion (Manual Intervention): In 4 out of 31 subjects, the procedure was completed successfully with manual insertion after initial system use. | |
| - Specifications Met: "The system met its predefined specifications for use to guide and advance an instrument during CT-guided interventional procedures." (Specific values not provided). | |
| - Serious Adverse Events: No serious adverse events reported for any of the subjects. | |
| Bench/Laboratory Tests (General Statements) | - Mechanical Accuracy: In accordance with ASTM F2554-10 (standard met). |
| - Registration Precision: Assessed in a simulated clinical environment. | |
| - CT Phantom Accuracy: Evaluated device performance and system accuracy. | |
| - Rigidity: Tested under different weight loads. | |
| - Axes Mapping: Evaluated performance specifications of each axis. | |
| - Needle Properties: Evaluated mechanical strength of compatible needles. | |
| - Body Contour & Movement/Respiration Synchronization: Evaluated compatibility and synchronization. | |
| - System Lifetime Testing: Conducted. | |
| - Electrical Safety: In accordance with IEC 60601-1 (standard met). | |
| - Electromagnetic Compatibility (EMC): In accordance with IEC 60601-1-2 (standard met). | |
| - Biocompatibility: In accordance with ISO 10993 (standard met). |
2. Sample size used for the test set and the data provenance
- Test Set (Pre-clinical animal study):
- Sample Size: 40 interventional procedures.
- Data Provenance: Porcine model (animal study). Specific country of origin is not mentioned, but it's a pre-clinical study.
- Test Set (Preliminary clinical data):
- Sample Size: 31 cases (interim set of subjects).
- Data Provenance: Clinical data gathered in 2 clinical centers. Specific country of origin is not mentioned. It is prospective data collection since it's described as "preliminary clinical data, to supplement the bench and preclinical animal testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts for "ground truth" establishment in the context of the animal or clinical studies. The results from the animal study (target reach, accuracy) and clinical study (successful target reach, adverse events) are presented as direct measurements. For the clinical data, the procedures were performed by physicians, as indicated by "physician defined trajectory path" and "manual insertion according to routine clinical procedure," implying the usual clinical practice standards would serve as the "truth" for procedure success and safety. However, the exact process of establishing ground truth by a panel of experts is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating outcomes in either the pre-clinical or preliminary clinical studies. Outcomes appear to be directly measured (e.g., distance from target, successful reach, reported adverse events).
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
No MRMC comparative effectiveness study is mentioned. The study focuses on the device's ability to assist in procedures, not on evaluating human reader performance with or without AI assistance, as the system is a robotic positioning system, not an AI-based diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "user-controlled positioning system" and "intended to assist in the planning and advancement of an instrument." It is designed for human-in-the-loop operation, where the physician controls advancement and defines the trajectory. Therefore, a standalone (algorithm only) performance evaluation without human interaction would not be applicable or described for this type of device. The accuracy results (1.41mm ± 0.94mm) from the animal study could be considered a measure of the system's standalone (robotic execution) accuracy once a trajectory is defined.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Pre-clinical Animal Study: The ground truth for accuracy was based on direct measurement of the "distance from the target" following robotic insertion in animal models. Successful target reach was also a direct outcome. Safety was assessed through reporting of adverse events.
- Preliminary Clinical Data: The ground truth for success appears to be whether the device "successfully reached the target" and whether the "procedure was completed successfully" (even if later by manual intervention). Safety was assessed by "no serious adverse events reported." These are outcomes-based or procedural success-based ground truths, likely determined by the operating physician and recorded.
8. The sample size for the training set
The document does not provide information about a "training set" for an AI algorithm because the XACT Robotic System is described as a "user-controlled positioning system," not explicitly an AI-driven image analysis or diagnostic tool that would typically undergo a separate training phase with a large dataset. While it has software for planning, the core function described is mechanical assistance and guidance.
9. How the ground truth for the training set was established
As no training set for an AI algorithm is mentioned, the method for establishing its ground truth is also not applicable or described in the provided text.
§ 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.