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510(k) Data Aggregation
(25 days)
USG 2000SA
The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.
The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan 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 US 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 text regarding the acceptance criteria and study for the UltraGuide USG 2000sa device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | The device underwent extensive bench tests for electrical safety and electromagnetic compatibility. The major components (computer, ultrasound system, PC Birds) are commercial devices with published environmental and physical specifications. The FDA determined the device is substantially equivalent to predicate devices in terms of safety. |
| Efficacy | The device uses the same technology as the predicate device (UltraGuide 1000, K974432). The FDA determined the device is substantially equivalent to predicate devices in terms of efficacy. |
Important Note: The provided document is a 510(k) summary for a medical device cleared in 2002. At that time, explicit quantifiable acceptance criteria (e.g., specific accuracy metrics, sensitivity, specificity) for device performance as we often see in modern submissions were not always explicitly stated or required in the same way for "substantial equivalence" claims. The focus here is on demonstrating equivalence to a legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or sample size for a clinical study is mentioned. The submission states, "Since this system uses the same technology as the predicate device, a clinical test is not necessary." This indicates that no new clinical data was generated for the USG 2000sa for its 510(k) clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no new clinical test set was used for the submission.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "a clinical test is not necessary."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is described as enhancing the ultrasonic image and predicting the needle path for display on a computer monitor. This implies a human-in-the-loop interaction, where the user interprets the enhanced image. A standalone (algorithm-only) performance evaluation, separate from human interaction, is not indicated or discussed for this type of device. The clearance is based on the technology being equivalent to a predicate, not on a new standalone performance claim.
7. The Type of Ground Truth Used
No new ground truth from clinical data was established for the USG 2000sa's 510(k) clearance. The basis for safety and efficacy was the substantial equivalence to the predicate device, UltraGuide 1000. For the bench tests, the "ground truth" would have been established by engineering standards for electrical safety and electromagnetic compatibility rather than medical ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that typically requires a large training set in the modern sense. Its function relies on established physical principles of magnetic tracking and visual overlay, rather than learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or implication of a training set for an AI/ML model.
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