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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 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 current Pantheris System (K160827), listed as the primary predicate device, consists of the Pantheris Catheter, Lightbox Sled with integrated Umbilical (referred to as "Sled") the Lightbox HS Imaging Console (referred to as "Lightbox") and the accessories that are packaged with the Pantheris Catheter: flush fixture, tweezers, syringes and stopcocks, and a Sterile Drape accessory that is packaged separately. The subject Pantheris System submitted as part of this 510(k) submission does not introduce any changes to the device specifications, materials or manufacturing processes and is identical to the current Pantheris System.

The Pantheris System combines the use of Avinger's Optical Coherence Tomography (OCT) technology (identical to the OCT Technology used in the Ocelot System (K140185)) with peripheral vascular atherectomy capabilities.

The Pantheris Catheter comes in both a 7Fr and 8Fr size. Both sizes have a working length of 110 cm and are sterile, single-use devices that are compatible with 7Fr and 8Fr 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, an isolation transformer and an OCT system.

The provided document is a 510(k) premarket notification for the Avinger Pantheris System. It states that the "subject Pantheris System submitted as part of this 510(k) submission does not introduce any changes to the device specifications, materials or manufacturing processes and is identical to the current Pantheris System (K160827)." Therefore, the document primarily relies on previous submissions (K160827 and K152275) for evidence of safety and effectiveness, including clinical testing.

As a result, much of the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes for test and training sets, and expert details for ground truth establishment is not directly present in this specific 510(k) submission. This document asserts substantial equivalence based on the lack of changes to the device and the use of the same technology as previously cleared devices.

However, I can extract information about the device's intended use and the general assertion of meeting specifications based on prior testing.

1. Table of acceptance criteria and the reported device performance:

Specific numerical acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy, or other quantifiable metrics) for the OCT-assisted imaging aspect of the Pantheris System are not provided in this document. The document primarily focuses on demonstrating substantial equivalence by stating the device is identical to a prior cleared device and uses the same OCT technology.

The "acceptance criteria" can be inferred as successful completion of the non-clinical tests and the established specifications referenced in previous submissions (K160827 and K152275).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• For the non-clinical studies: The document refers to "Design verification and bench validation studies," "Packaging and shelf-life," "Software verification and validation," "Electrical safety, electromagnetic compatibility, and laser safety testing," "Biocompatibility," "In-vivo animal validation study," and "Sterilization." The specific sample sizes for these tests are not detailed in this document, as it relies on prior submissions. The provenance is not specified.

• For clinical testing: The document explicitly states: "Clinical testing of the Pantheris System was included for the secondary predicate, the initial Pantheris System original 510(k) submission (K152275). Due to the equivalence between the Systems no new clinical testing is included in this 510(k) submission." Therefore, details of sample size and provenance for clinical testing would need to be found in the K152275 submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in this document. It would likely be contained within the clinical study reports referenced in the K152275 submission if such studies established ground truth for performance metrics. The "OCT image comparisons" mentioned imply expert review, but details are not given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in this document. It would depend on the design of any clinical studies for K152275.

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:

The document describes the Pantheris System as an atherectomy device that uses OCT-assisted orientation and imaging, an "adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies." It's a device with an imaging component, not primarily an AI-driven diagnostic tool that assists human readers in interpreting images for improved accuracy like in a typical MRMC study setting for AI comparison. Therefore, an MRMC comparative effectiveness study in the context of "human readers improve with AI vs without AI assistance" is not explicitly mentioned or implied as the primary mode of effectiveness testing for this historical device.

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

The device is described as "OCT-assisted orientation and imaging" and an "adjunct to fluoroscopy." This implies that the imaging component is an integral part of a human-in-the-loop interventional procedure, not a standalone diagnostic algorithm. Therefore, "standalone (algorithm only)" performance in the typical sense of AI diagnostics is not applicable or discussed for this device.

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

This specific detail for the clinical testing (referenced from K152275) is not provided in this document. However, for a device intended to remove plaque and provide images of vessel morphology, ground truth might typically involve histopathology (pathology) from excised tissue, angiography, or other validated imaging modalities.

8. The sample size for the training set:

The document makes no mention of a "training set" in the context of an AI/machine learning algorithm. The OCT technology is described as "using a PC-based processing system" to interpret signals, but it does not specify if this involves a machine learning model that requires a distinct training set. If the "PC-based processing system" contains a machine learning component, information about its training set is not included in this document.

9. How the ground truth for the training set was established:

As no "training set" is discussed in this document, this information is not provided.

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