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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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