(229 days)
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).
The Orbital Atherectomy System (OAS) is intended for use in treatment of artificial arteriovenous dialysis fistula stenosis. An artificial arteriovenous dialysis fistula (A-V shunt) is placed sub-dermal to support kidney dialysis. A consequence of the body's reaction to the foreign material of the A-V shunt is to form clots and neointimal stenosis of the A-V shunt. The most common location for A-V shut stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System is applied to remove neointimal tissue causing a stenosis in the A-V shunt.
The Orbital Atherectomy System (OAS) provides a method of removing occlusive neointimal tissue. The OAS applies a diamond coated, eccentrically rotating cutting surface to ablate neointimal tissue. The resulting particles of removed neointimal tissue are very small and can be absorbed by the body.
This document is a 510(k) premarket notification for the Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS). It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating performance against such criteria. The "Summary of Safety and Effectiveness" primarily discusses the device's technical aspects, intended use, and comparison to predicate devices, rather than data from a performance study with defined acceptance criteria.
Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be extracted directly from the provided text.
Here's an attempt to answer the questions based on the available information, noting the missing details:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document primarily focuses on establishing substantial equivalence based on intended use and technology, rather than presenting a performance study with specific acceptance criteria and results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The document mentions "Laboratory and animal data" but does not provide details on sample sizes, provenance, or study design (retrospective/prospective).
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 present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
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
This information is not present in the provided document. The device is a physical medical device (atherectomy system), not an AI-based diagnostic tool, so an MRMC study related to human reader performance with AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present and not applicable as the device is a physical atherectomy system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document refers to "Laboratory and animal data" as support for safety. It's highly probable that pathology/histology and direct observation of animal tissue would have been used as ground truth for assessing the efficacy of tissue removal and safety aspects in the animal studies. However, explicit details are not provided.
8. The sample size for the training set
This information is not present in the provided document. The concept of a "training set" is typically associated with AI/machine learning models and is not relevant for this type of physical medical device submission.
9. How the ground truth for the training set was established
This information is not present and not applicable for a physical medical device.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).