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The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris System consists of the Pantheris catheter, Lightbox Sled with integrated Umbilical (referred to as "Sled") and the Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris Catheter comes in both a 7Fr and an 8Fr size. Both sizes have a working length of 110 cm and are sterile, single-use devices that are compatible with 7 and 8F sheaths (respectively) and 0.014" guidewires. The Pantheris Catheter incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure. The Pantheris catheter is connected to the Lightbox via the Sled. The Lightbox is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Pantheris Catheter and receiving and interpreting the signal from the tissue using a PCbased processing system. The Lightbox provides a visualization platform for the real-time OCT-assisted directional atherectomy. The Lightbox consists of a cart with two monitors, a PC-based processing system, software, an isolation transformer, and an OCT system.

The provided document is a 510(k) Summary for the Pantheris System, which describes modifications to an already cleared device. This submission focuses on demonstrating that these modifications do not impact the safety and effectiveness of the device compared to its predicate. Therefore, the "acceptance criteria" and "device performance" primarily revolve around showing equivalence to the predicate and passing various safety and performance tests.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions that "Testing was performed to demonstrate that these changes do not impact the safety and effectiveness of the final device."

• Test Set Sample Sizes: Not explicitly stated for each test.
• Data Provenance: The studies are described as "Performance Data" from various tests (Biocompatibility, Electrical Safety, EMC, Software, Mechanical). These are laboratory-based, non-clinical tests conducted by the manufacturer to demonstrate compliance with standards and equivalence. There is no mention of country of origin for the data or if it's retrospective or prospective, as these are device performance tests, not clinical studies on patients.

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

This type of information is not applicable (N/A) to this 510(k) submission. The submission describes a device with mechanical, electrical, and software components, not an AI or diagnostic application requiring expert review for ground truth in a test set. The performance tests (e.g., destructive balloon burst, torque capacity) rely on engineering specifications and physical measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers interpreting medical data, not for engineering performance tests of a physical device.

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

No, an MRMC comparative effectiveness study was not done, and this type of study is not applicable (N/A) to this 510(k) submission. This submission is for modifications to an atherectomy system that includes OCT imaging as an adjunctive visualization tool, not an AI-powered diagnostic system requiring human reader performance evaluation.

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

This information is not applicable (N/A). While the device contains software and OCT imaging, it is an interventional atherectomy system. The OCT provides real-time, surgeon-guided visualization, it's not a standalone diagnostic algorithm that would typically undergo "algorithm-only" performance testing in the context of a 510(k) for an AI device. The software update specifically mentioned is an attenuation of the laser when the drive is not rotating, a safety feature, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on engineering specifications, established physical properties, and compliance with recognized standards. For example:

• Biocompatibility: Adherence to ISO standards for material compatibility.
• Electrical/EMC Safety: Compliance with IEC standards (e.g., IEC 60601-1).
• Mechanical Testing: Meeting specified tensile strengths, torque capacities, leak rates, burst pressures, cycle counts, dimensional accuracies, and plaque removal efficiency based on defined test methods.
• Software Validation: Successful execution of test cases against documented requirements and expected outcomes.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these device modification performance tests.

8. The Sample Size for the Training Set

This information is not applicable (N/A) as the device functionality described does not involve a "training set" in the context of machine learning or AI algorithms requiring such a dataset. The software update mentioned is a safety feature for laser attenuation, not a complex algorithm dependent on a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable (N/A) for the same reason as point 8.

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The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0mm, using OCT-assisted orientation and imaging. The system as an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris System (cleared under K162326) combines the use of Avinger's Optical Coherence Tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris System consists of the Pantheris Catheter, Lightbox Sled with integrated Umbilical (referred to as "Sled") and the Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris Catheter is connected to the Lightbox via the Sled. The Lightbox is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Pantheris Catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The Lightbox provides a visualization platform for the real-time OCT-assisted directional atherectomy. The Lightbox consists of a cart with two monitors; a PC based processing system, software, an isolation transformer and an OCT system. This Special 510(k) introduces an optional vessel measurement feature to the Pantheris System software in the Lightbox HS Imaging Console.

This document is a 510(k) premarket notification for a medical device called the Pantheris System, specifically focusing on a software modification that introduces an optional vessel measurement feature. It's important to note that this document is not a clinical study report but rather a regulatory submission demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain extensive clinical trial data or detailed performance metrics as one might find in a full clinical study publication. However, it does discuss verification and accuracy testing for the new feature.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "the accuracy of the measurement feature was assessed and found to be within the specified acceptance criteria." However, it does not explicitly list the acceptance criteria or the specific reported device performance values for the measurement feature. It only broadly states they were met.

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

The document refers to "software verification and measurement accuracy testing." This testing appears to be non-clinical in nature, as stated in the section "Non-Clinical Test Data." It does not mention a specific test set of patient data, but rather testing of the software's ability to measure simulated or in-vitro data. There is no information provided on the sample size for this test set, nor on data provenance (country of origin, retrospective/prospective), as it's not a clinical study involving patients.

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

Given that the testing was described as "non-clinical" and focused on software verification and measurement accuracy, it's highly unlikely that human experts were used to establish ground truth in the traditional sense of clinical image interpretation. The ground truth would likely be established by known physical dimensions in simulated or in-vitro models. Therefore, this information is not applicable in the context of this document.

4. Adjudication Method for the Test Set:

As no human experts or patient data are described for the test set, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

The document does not describe an MRMC comparative effectiveness study, nor does it mention any human reader performance or improvements with AI assistance. The modification is described as providing "an optional confirmation of their initial vessel diameter/size assessment" and "additional information." It's not presented as an AI-powered diagnostic tool that directly aids human readers in their primary diagnosis.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document describes "measurement accuracy testing" for the new vessel measurement feature as part of "software verification." This implies a standalone performance evaluation of the algorithm's measurement accuracy against known values (ground truth) in a non-clinical setting. The results are summarized as "found to be within the specified acceptance criteria," though the criteria and specific numbers are not provided.

7. The Type of Ground Truth Used:

For the "measurement accuracy testing," the ground truth would have been established by known physical dimensions or precisely measured values in the non-clinical test environment (e.g., phantoms, simulated vessels, or in-vitro models). The document doesn't explicitly state the type of ground truth but implies it's a quantitative comparison to a known standard.

8. The Sample Size for the Training Set:

This document describes a software modification to an existing device, not a new algorithm developed from scratch. Therefore, it does not provide information on a training set sample size. The focus is on verifying and validating the new feature's performance, not on a machine learning model's training process.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set, there is no information on how its ground truth would have been established.

In summary:

This 510(k) submission addresses a minor software modification (addition of a vessel measurement feature) to an already cleared device. The "study" described is a non-clinical software verification and measurement accuracy testing. It demonstrates that the new feature meets its internal specifications and acceptance criteria, without raising new safety or effectiveness concerns. It is not a clinical trial and thus lacks the detailed clinical performance metrics (e.g., sensitivity, specificity, reader performance) typically associated with such studies.

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