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The Guided Medical Positioning System (gMPS™) is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a gMPS™ enabled (equipped with a gMPS™ sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

The gMPS™, used in conjunction with an X-ray System, employs magnetic positioning technology to track a gMPS™ enabled diagnostic or therapeutic invasive device for the 3D position relative to any X-ray image, in real-time or previously recorded cine-loop.

The gMPS™ system is intended to provide the following:

Catheter tip positioning and navigation - The real time position of the gMPSTM sensor (and thus of the gMPS™ enabled device) is displayed in real time ("Live") fluoroscopy mode or in a recorded mode.

Smart trace (foreshortening indication) - A 3D trace of the gMPS™ enabled device trajectory is projected and superimposed on the 2D X-ray images (either on live fluoroscopy, recorded cine-loop or recorded still image).

3D reconstructed model - The system reconstructs a 3D model of the inspected anatomical structure.

Quantitative longitudinal measurements - The measurements are based on the 3D trace, thus overcoming length measurement errors induced by the foreshortening effect.

Quantitative Coronary Angiography (OCA) - While working in conjunction with gMPSTM enabled coronary device, the gMPS™ provides 3D QCA.

Virtual landmarking - A manually marked point or region of interest superimposed on X-ray images (real-time angiography and cine-loop) and on the 3D reconstruction.

Here's a breakdown of the acceptance criteria and study information for the Guided Medical Positioning System (gMPS™), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria or specific performance metrics with target values. Instead, it makes a general statement about performance testing.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was conducted."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided text does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not mention if a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document.

6. Standalone (Algorithm Only) Performance Study

The provided text describes the device's function as "real time tip positioning and navigation" and states "Performance testing was conducted in order to demonstrate the performance and accuracy of the gMPS™ and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices." This implies that the algorithm's performance in guiding the device was evaluated, which aligns with a standalone performance study. However, specific details of this study are not provided.

7. Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the device's function for "real time tip positioning and navigation" and "3D reconstructed model" of anatomical structures, it's highly likely that ground truth would involve either:
* Direct measurement/imaging: Comparing the system's reported position/reconstruction to a known physical measurement or a high-accuracy imaging modality.
* Expert validation: Clinical experts confirming the accuracy of the system's output against their anatomical knowledge or other reference images.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

9. How Ground Truth for the Training Set Was Established

The provided text does not specify how ground truth for the training set was established.

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