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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 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris System consists of the Pantheris Catheter, Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console and the Sterile Drape (accessory).

The Pantheris System and its modified version (K153460) are intended to remove plaque from partially occluded peripheral vasculature. The device uses OCT-assisted orientation as an adjunct to fluoroscopy.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a quantitative manner that would typically be seen for diagnostic device accuracy (e.g., sensitivity, specificity, AUC). Instead, the studies performed are primarily focused on demonstrating the safety and effective function of the device's modifications and ensuring substantial equivalence to a previously cleared predicate device.

The acceptance criteria for this device seem to be implicitly defined by the successful completion of various non-clinical engineering and biological tests, and the modified device's performance matching or exceeding that of its predicate. The "reported device performance" is qualitative and indicates "meets established specifications necessary for consistent performance for its intended use."

The identified non-clinical tests and their implicit acceptance criteria are:

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

The document mentions a "Porcine Study" as a preclinical animal test. The sample size for this study is not explicitly stated, only that it involved "acute and chronic histopathological assessments." The data provenance is from an animal model (porcine), and it is a prospective study design to evaluate the modified device. No human test set data is provided or referenced in this 510(k) summary for this specific modification. The study is a "comparison to a predicate device."

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

For the preclinical porcine study, the documentation refers to "histopathological assessments." This implies that experts (likely veterinary pathologists) were involved in establishing the ground truth regarding tissue response and safety. However, the exact number of experts and their specific qualifications (e.g., "veterinary pathologist with X years of experience") are not provided in this document.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set, as it does not present a clinical study with human outcomes that would typically require independent expert adjudication. For the animal study, the pathological assessments would likely follow standard practices for veterinary pathology reporting, but no specific adjudication process (e.g., 2+1, 3+1 consensus) is detailed.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance or human reader improvement. The Pantheris System (and its modification) is a medical device for atherectomy, and while it uses "OCT-assisted orientation," this is not presented as an AI-driven diagnostic aid for human readers.

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

This document describes a medical device rather than an algorithm. Its performance is assessed through engineering tests, biocompatibility, and preclinical animal studies. Therefore, the concept of "standalone algorithm performance" is not applicable here. The device's OCT imaging component is an "adjunct to fluoroscopy" and is part of a human-operated system for guided intervention.

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

For the preclinical animal study, the ground truth was primarily established through pathology (histopathological assessments). The functional aspects of the device in vivo were also evaluated. For the extensive non-clinical and design validation testing, the ground truth was based on pre-defined engineering specifications and performance standards.

8. The Sample Size for the Training Set

This document does not describe the development of an artificial intelligence or machine learning algorithm. Therefore, the concept of a "training set" in that context is not applicable. The device's design and modifications are based on engineering principles and iterative design, not on machine learning training data.

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

As there is no mention of an AI/ML algorithm or a training set in this document, this question is not applicable.

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