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The GMC™ device is a gMPS™ enabled intravascular catheter intended for the diagnostic evaluation of the coronary vasculature in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI).

The GMC™ is used with compatible gMPS™ system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking.

The System is indicated for use as an adjunct to fluoroscopy.

The Guided Measurement Catheter (GMC™) is a Medical Positioning System (gMPS™) enabled coronary diagnostic catheter designed to allow catheter tracking during a routine diagnostic catheterization of the coronary arteries using the MediGuide's gMPS™ system. The catheter includes an embedded gMPS™ sensor in order to allow its tracking by the gMPSTM system.

The GMC™ gMPS™ enabled catheter is intended to be used during a percutancous coronary procedure, and similarly to an IVUS assessment, inserted to a target coronary artery, usually past a stenotic region, and then pulled back manually, to screen the selected arterial segment. As the pullback is completed, the 3D trace of the catheter's trajectory is reconstructed and displayed separately in a 3D display, and also superimposed on the 2D X-ray image by the gMPS™ system. The superimposed trace, the Smart Trace, is color coded to show an indication of the angular percent of foreshortening of the artery as it exists in the respective X-ray image. A model of the artery's lumen is automatically generated by the gMPS™ system from only one X-ray image, taken from a single angle (projection).

Here's an analysis of the provided text regarding the Guided Measurement Catheter (GMC™) and its acceptance criteria and supporting study information.

It's important to note that the provided text is a 510(k) summary and FDA clearance letter, which focuses more on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data in a tabular format. Therefore, some information may need to be inferred or is explicitly stated as being performed without detailed results.

Acceptance Criteria and Device Performance Study for the Guided Measurement Catheter (GMC™)

The provided document, a 510(k) summary for the MediGuide Ltd. Guided Measurement Catheter (GMC™), details the device's intended use and claims substantial equivalence to predicate devices based on safety and performance testing. While specific numerical acceptance criteria for each function are not explicitly laid out, the overall acceptance criterion is demonstrating that the GMC™ is "as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues."

The summary indicates that "A set of bench, animal and clinical testing was performed in order to demonstrate the safety and performance of the GMC™ and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices."

Unfortunately, the document does not contain a specific table of acceptance criteria paired with reported device performance for each feature. It broadly states that tests were performed and indicated substantial equivalence.

Based on the information available, here are the details regarding the study:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a specific table with numerical acceptance criteria and performance metrics (e.g., accuracy for length measurement, real-time performance for tracking) is not provided in this 510(k) summary. The summary concludes that "Tests results indicated that the GMC™ is as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices." This implies that the device met internal design specifications and performed comparably to the predicate devices in the conducted studies, thereby meeting the overarching acceptance criterion of substantial equivalence.

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

The document mentions "bench, animal and clinical testing" were performed. However, it does not provide any specific sample sizes for these test sets (e.g., number of animals, number of clinical cases/patients). The provenance of data is also not specified (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

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

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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in the provided 510(k) summary. The device's primary function described is to provide diagnostic information and guidance, not to assist human readers in interpreting images in a comparative effectiveness setting.

6. Standalone (Algorithm Only) Performance Study

The device is an "intravascular catheter intended for the diagnostic evaluation" that "is used with compatible gMPS™ system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking." The system is also "indicated for use as an adjunct to fluoroscopy."

Given this description, the "device" (GMC™ catheter) works in conjunction with the gMPS™ system to perform its intended functions. Therefore, its performance is inherently tied to the system. The phrase "A model of the artery's lumen is automatically generated by the gMPS™ system from only one X-ray image" suggests an algorithmic component. However, the document does not explicitly detail a standalone (algorithm only) performance study decoupled from the overall system's operation or human interaction/supervision. The tests performed ("bench, animal and clinical testing") would likely encompass the integrated system's performance.

7. Type of Ground Truth Used

The document does not explicitly specify the type of ground truth used for the testing (e.g., expert consensus, pathology, outcomes data). In the context of a diagnostic intravascular catheter, ground truth for measurements (like length, 3D reconstruction accuracy) would typically involve comparison to a gold standard measurement method (e.g., precise physical measurements in bench models, highly accurate imaging modalities or direct measurements in animal/clinical settings).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is likely because the device, as described, performs real-time measurement and reconstruction based on physical principles and sensor data, rather than being a machine learning algorithm trained on a large dataset in the conventional sense. While it has a "computerized system," the text suggests it's more about processing sensor data and known anatomical models than a deep learning approach requiring a distinct training phase.

9. How Ground Truth for the Training Set Was Established

Since information regarding a training set is not provided, the method for establishing its ground truth is also not specified.

Summary of Missing Information:

It's crucial to understand that 510(k) summaries are designed to establish substantial equivalence for market clearance, not to be comprehensive scientific study reports. They often lack the granular detail on study design, sample sizes, specific performance metrics, and ground truth methodologies that would be found in a peer-reviewed publication or full study report. The intent here is to demonstrate that the device is not new or significantly different from existing devices and is safe and effective.

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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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