(153 days)
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
The IOPS system displays the position and orientation of sensor equipped guidewires and catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time superimposing navigation of the catheters and guidewires to the patient's vascular map.
The patient's vascular map is generated using a contrast enhanced, high resolution CT scan. The IOPS creates a 3D rendering of that structure. A bone segmented 3D rendering may optionally be created to provide anatomical, skeletal points visible in relation to the vascular rendering.
The main principles of action for the IOPS are similar to those used in Global Positioning System (GPS) tracking. The navigation components generate a time-varying magnetic field in which the position and orientation of sensor embedded catheters and guidewires are read. The computing unit visually displays the location of the sensor on the patient's vascular map.
The system is intended for use by trained clinicians for patients undergoing endovascular interventional procedures of the descending aorta, such as stent grafting. The system promotes more efficient use of operating room time and minimizes the need for fluoroscopy. The clinician uses the IOPS catheters and guidewires to navigate through the aorta to access branch vessels near to, or involved in, the lesion. The catheters and guidewires are not for angiographic or diagnostic use.
IOPS is composed of a mobile cart which houses a monitor, computer, keyboard, pointing device, uninterruptable power supply (UPS), and cables. IOPS includes a tracking system composed of a system control unit (SCU), system interface unit (SIU), field generator, mounting brackets, and cables. These components are reusable and not patient contacting. The IOPS is integrated with software to generate the mapping and overlay of the live sensors. The IOPS works with a sensor embedded catheter, guidewire, and tracking pad which are provided sterile and not intended for re-use.
The provided document describes the FDA 510(k) clearance for the Centerline Biomedical Intra-Operative Positioning System (IOPS). Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a specific table of quantitative acceptance criteria with corresponding performance metrics like a typical validation study might. Instead, it broadly states that performance testing was conducted to demonstrate the performance and accuracy of the IOPS and verify substantial equivalence to the predicate device, not raising new safety or effectiveness concerns.
The functional performance testing included:
- Lag testing
- Accuracy testing per ASTM F2554
- X-ray artifact testing
However, the specific acceptance criteria (e.g., maximum lag accepted, accuracy tolerance, X-ray artifact visibility limits) and the quantitative results (e.g., actual lag measured, accuracy values achieved) are NOT provided in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Porcine animal studies for usability testing and functional evaluation" but does not specify the sample size (number of animals or number of tests conducted within those animals) for these studies. The data provenance is animal (porcine) and would be considered prospective for the purposes of the study described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to "usability testing and functional evaluation" in animal studies, but it doesn't detail how ground truth was established, especially regarding expert involvement.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted, or at least not described in this 510(k) summary. The study focuses on device performance and usability in animal models. The indication for use states the IOPS is an "adjunct to fluoroscopy" and "does not make a diagnosis," suggesting it augments human performance rather than replacing it, but no study quantifying this improvement is presented.
6. Standalone Performance Study
The document describes "functional performance testing" including "accuracy testing per ASTM F2554," "Lag testing," and "X-ray artifact testing." These are standalone performance tests of the algorithm/system without human-in-the-loop performance. However, as noted in point 1, the specific quantitative results are not disclosed.
7. Type of Ground Truth Used for the Test Set
For the "functional evaluation" in porcine animal studies, the ground truth would likely be established through direct observation during the procedures, physical measurements taken from the animal, or potentially correlation with other imaging modalities (e.g., 3D imaging from the animal) if applied. The document does not explicitly state the method. For "accuracy testing per ASTM F2554," ASTM standards typically define methods for establishing a traceable ground truth (e.g., using a reference measurement system with known accuracy).
8. Sample Size for the Training Set
The document does not provide any information regarding a training set size. This 510(k) summary describes a hardware and software system for navigation, not a machine learning or AI model trained on a large dataset for diagnostic purposes. The software generates 3D renderings from previously acquired CT scan data and utilizes electromagnetic tracking.
9. How Ground Truth for the Training Set Was Established
Since a training set for an AI model is not mentioned or implied by the device's description, this section is not applicable. The device's operation is based on electromagnetic tracking principles and 3D rendering of CT data, not on learning from a large dataset with established ground truth.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).