Search Results

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.

Ask a specific question about this device