(28 days)
The XACT Robotic System, ACE Model 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 guides (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, ACE Model comprises the following main components:
- . XACT Robot which is placed on the patient and includes the robot positioning unit & the insertion module assembly
- . XACT 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
I am sorry, but the provided text does not contain the detailed information necessary to answer your request fully. The document is an FDA 510(k) clearance letter and a summary of the device's characteristics and performance tests.
Here's what I can provide based on the given text, and what is missing:
Information available from the text:
- Device Name: XACT Robotic System, ACE Model
- Predicate Device: XACT Robotic System (K191332)
- Performance Tests Conducted: Mechanical Accuracy, Registration Precision, CT Phantom Accuracy, Robot Rigidity, Axes Mapping, Complete SW STD, Electrical safety (IEC 60601-1), Electromagnetic compatibility (IEC 60601-1-2).
Missing Information:
The text does not provide the following crucial details needed for your request:
- A table of acceptance criteria and reported device performance: While performance tests are listed, the specific acceptance criteria for each test and the quantitative results showing the device met those criteria are not provided.
- Sample sizes used for the test set and data provenance: The document mentions tests but not the number of cases or samples used, nor the origin (country, retrospective/prospective) of any data if clinical studies were performed.
- Number of experts and their qualifications for establishing ground truth: This information is not present.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: The text indicates performance and safety tests, but not comparative effectiveness studies with human readers.
- If a standalone study (algorithm only) was done: The device is a "user-controlled positioning system intended to assist in the planning and advancement of an instrument." This suggests it's a human-in-the-loop system, and a standalone algorithm performance without human interaction isn't directly relevant or discussed.
- The type of ground truth used: Not specified.
- Sample size for the training set: The document describes performance tests and comparisons to a predicate device, but not a "training set" in the context of an algorithm's development. This device is a robotic system, not an AI diagnostic algorithm in the typical sense that would have a training set of data.
- How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is mentioned.
Conclusion based on the provided text:
The document describes a robotic system that assists in CT-guided procedures. It outlines several engineering and safety performance tests that were conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide the specific quantitative acceptance criteria or results from these tests, nor does it delve into the details of clinical study design that would involve ground truth establishment, expert adjudication, or reader studies. It primarily focuses on the device's technological characteristics and safety and effectiveness from an engineering standpoint, rather than a diagnostic algorithm's performance.
§ 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.