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The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic side branch vasculature.

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

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

The LumiGuide system consists of the following primary devices:

The LumiGuide Wire is a sterile, single use, angiographic quidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.0 using FORS technology.

The LumiGuide Equipment R2.0 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or prerecorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.0 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component,

The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.0 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.0 enables real time 3D visualization of the connected endovascular catheter.

The provided text describes a 510(k) submission for the LumiGuide system, which appears to be an updated version of the existing AltaTrack system. The key takeaway from the document is that the FDA granted a substantial equivalence determination based on non-clinical performance data and a comparison of technological characteristics and indications for use. The document explicitly states that no clinical study data was required or performed for this substantial equivalence determination.

Therefore, there is no information in the provided text regarding acceptance criteria for device performance studies, nor results from such studies (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details). The substantial equivalence was established through non-clinical performance testing.

Here's the breakdown of what can be extracted from the text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document implies that the acceptance criteria were met by demonstrating compliance with applicable international and FDA recognized consensus standards and FDA guidance documents. Specific quantitative criteria are not listed.
• Reported Device Performance: Non-clinical performance testing demonstrated that "all executed tests were passed." These tests covered "risk control measures as well as system level requirements, such as dimensional, mechanical and packaging related requirements." Validation testing also covered "intended use, service, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. No clinical test set was used for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. Ground truth for a clinical test set was not established as no clinical study was performed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. No clinical study, including MRMC, was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided. The device (LumiGuide Equipment R2.0) is a "visualization device" intended to "aid the positioning and navigation" of the guidewire/catheter. Its performance in isolation (standalone) in a clinical context was not assessed via a clinical study for this submission. The non-clinical testing covered the functionality of the equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical performance testing, the ground truth would have been established by engineering specifications, validated test methods, and industry standards. The document doesn't detail the specific "ground truth" types for these engineering and usability tests beyond stating compliance with standards.

8. The sample size for the training set

• Not applicable/Not provided. This submission does not describe a machine learning or AI algorithm that would require a training set in the typical sense. It is a visualization and navigation aid.

9. How the ground truth for the training set was established

• Not applicable/Not provided. (See point 8).

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