(25 days)
The CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.
The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.
The CTG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the CT image of the internal organs, all displayed on the monitor of a personal computer.
The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device, and the video of the CT image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
Here's an analysis of the provided 510(k) summary regarding the UltraGuide CTG 2000sa device:
Based on the provided text, the device does not have explicitly stated acceptance criteria or a detailed study proving its direct performance against such criteria. The submission relies heavily on substantial equivalence to a predicate device and a lack of necessity for a clinical test due to using the same technology.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence and safety/efficacy relative to a predicate device. | The device underwent "Accuracy tests ... in phantoms." No specific metrics or thresholds for accuracy are provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No dedicated "test set" for a clinical study is described. The "accuracy tests" were performed in phantoms, but no sample size for these phantom studies is mentioned.
- Data Provenance: Not applicable. No human data (retrospective or prospective) is mentioned in the context of device performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No human test set or ground truth establishment by experts is described for this device's performance evaluation.
4. Adjudication Method for the Test Set
- Not applicable. No human test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. The document explicitly states: "Since this system uses the same technology as the predicate device, a clinical test is not necessary."
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done?: Yes, to some extent, in the form of "Accuracy tests ... in phantoms." However, the details of these tests, including specific metrics, performance thresholds, and a statistical analysis, are not provided. The device's primary function is to provide visual enhancement and guidance for a human operator, so a purely standalone performance would be about the accuracy of its display.
7. Type of Ground Truth Used
- For "Accuracy tests in phantoms": The ground truth would likely be the known, precisely measured positions and paths within the phantoms.
- Overall: The submission relies on the established safety and efficacy of the predicate device, CT-Guide 1010 (K002258).
8. Sample Size for the Training Set
- Not applicable. This device is a visualization and guidance system based on physical tracking technology and computational overlay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set for a machine learning model.
§ 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.