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The AltaTrack Equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and, optionally, a catheter during endovascular procedures of the peripheral, aortic side branch vasculature, by creating a 3D image in real-time of the connected AltaTrack Guidewire and, of an endovascular catheter, when combined with a AltaTrack 3D Hub.

The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the peric and aortic side branch vasculature.

The AltaTrack 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with an AltaTrack Guidewire and the AltaTrack Equipment.

The AltaTrack system consists of the following primary devices:

The AltaTrack Equipment R1.2 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and, optionally, an endovascular catheter when combined with AltaTrack 3D Hub, and overlay it on real-time or prerecorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.

The AltaTrack Equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

The AltaTrack Guidewire is a single-use, sterile, hydrophilic guidewire with FORS technology.

The primary function of the AltaTrack Guidewire is to direct an AltaTrack Catheter or other compatible catheter to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.

The AltaTrack 3D Hub is a single-use, sterile accessory to the AltaTrack Equipment R1.2. The AltaTrack 3D Hub connects to the luer connector of endovascular catheters. When the AltaTrack 3D Hub is connected to an endovascular catheter and is used in combination with an AltaTrack Guidewire, the AltaTrack Equipment R1.2 enables real time 3D visualization of the connected endovascular catheter.

The provided text is a 510(k) summary for the Philips AltaTrack system, not a study evaluating a medical device's performance against detailed acceptance criteria using a test set, ground truth experts, or elaborate statistical methods like MRMC studies.

The document states:

• "Substantial equivalence of the AltaTrack Equipment R1.2 and the AltaTrack 3D Hub did not require clinical study data, since substantial equivalence was demonstrated with the following attributes: Indication for use; Technological characteristics; and Non-clinical performance testing."
• "These attributes demonstrated that the clinical performance of the modified devices is substantially equivalent to the predicate devices."
• "Software verification testing of the functional, non-functional and user interface requirements as well as performance testing has been performed to cover system level requirements as well as risk control measures. Results demonstrated that all executed tests were passed."

Therefore, based on the provided text, it is not possible to describe the acceptance criteria and a study proving the device meets them in the way requested by the prompt for a performance study. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and shared indications for use and technological characteristics, not on a prospective performance study with a test set, ground truth adjudication, or a multi-reader, multi-case study.

In summary, the provided document does not contain the information required to answer the prompt's specific questions regarding acceptance criteria and performance study details.

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