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The Pantheris SV is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCTassisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris SV is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris SV catheter is a monorail (rapid exchange) device with a working length of 144 cm, compatible with a 6 French sheath and an 0.014" guidewire. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, and a flexible, tiltable nosecone. The catheter is sterilized by electron beam radiation and is intended for single use only. The Pantheris SV is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.

This document is a 510(k) summary for the Pantheris SV atherectomy catheter. It describes the device, its intended use, and compares it to a predicate device and a reference device. It also details the non-clinical performance data supporting the device's substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a tabular format for each test. Instead, it states that the device "passed all tests" or that parameters were "ranked from 'good' to 'excellent'." No specific quantitative acceptance values are provided, as this is a 510(k) submission focused on substantial equivalence rather than a detailed performance study with pre-defined statistical endpoints for a new technology.

However, based on the Mechanical Testing and Animal Testing sections, we can infer some performance indicators:

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

• Mechanical Testing: The document does not specify the exact sample size (number of catheters/units) used for each mechanical test. It lists the types of tests conducted.
• Animal Testing: Two pigs were enrolled in this study.
  • Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. While the country isn't explicitly stated, GLP studies are typically highly regulated, and the context of an FDA submission suggests it was conducted under U.S. or comparable international standards. It is a prospective study for the purpose of demonstrating safety and performance.

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

For the animal study, the document mentions "gross necropsy and histopathology" which would typically involve qualified veterinary pathologists. However, the number of experts or their specific qualifications (e.g., board-certified veterinary pathologist with X years of experience) are not specified in this summary. The ranking of treatment evaluation parameters from "good" to "excellent" implies expert assessment, but the details are missing.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the animal study or mechanical testing. Given the summary's content, it's likely that a single expert or a team within the company assessed the results of the animal study, but no formal adjudication process (like 2+1 or 3+1 consensus) is outlined.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing of the subject device was necessary." The testing involved mechanical and animal studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Pantheris SV catheter incorporates Optical Coherence Tomography (OCT) for imaging, and the "Lightbox Console" has software (version 4.4.0). The device is characterized as "OCT-assisted orientation and imaging" with the system acting "as an adjunct to fluoroscopy." This implies human interaction/interpretation of the OCT images for directional atherectomy. Therefore, a purely standalone algorithm without human-in-the-loop performance cannot be definitively inferred from this document as the primary mode of operation. The "Imaging Capabilities" section describes the system as one to "facilitate atherectomy" and "identify clinically relevant morphologies," which suggests human interpretation of the images provided by the device.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth is established by engineering specifications, standardized test methods (e.g., BS EN 1707:1997, ISO 10555-1:2013), and direct physical measurement/observation against those specifications.
• Animal Testing: Ground truth for safety was established by gross necropsy and histopathology performed by veterinary professionals (implied, though not explicitly stated as "experts"). Ground truth for performance was based on direct observation during the procedure and subsequent evaluation/ranking by the study team.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a medical device (atherectomy catheter with OCT imaging). It is not an AI/Machine Learning submission where a training set of data for an algorithm would be used in the conventional sense. The "Software Verification and Validation Testing" refers to the Lightbox component's software, but this typically involves testing the software against functional requirements and software design specifications, not training an AI model with a data set. Therefore, a "training set" as understood in AI systems is not applicable to this submission.

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

As explained in point 8, a "training set" for an AI model is not applicable to this submission. The "ground truth" for the device's functional software would be its adherence to documented software requirements and design specifications, established through V&V activities.

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