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The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically rotating sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

• 1. Orbital Atherectomy Device (OAD)
• 2. Atherectomy Guide Wire (e.g., ViperWire Advance)
• 3. Saline Infusion Pump (SIP)
• 4. Atherectomy Lubricant (e.g., ViperSlide)

Here's an analysis of the provided text regarding the acceptance criteria and study for the Diamondback 360® Peripheral Orbital Atherectomy System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria with specific numerical targets. Instead, it states that the device "met the established specifications necessary for consistent performance during its intended use" and "met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."

However, based on the performance bench testing conducted, we can infer the categories of acceptance criteria:

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

The document describes bench testing and biocompatibility testing, not clinical trials involving human subjects or data sets in the traditional sense of AI/diagnostic device evaluation. Therefore, there is no "test set" of patient data, nor is there information on data provenance (country of origin, retrospective/prospective) for such a test set. The "test set" here refers to the physical devices and materials undergoing various engineering and biological assessments.

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

This is not applicable as the study involved bench testing and biocompatibility testing of a physical medical device, not the evaluation of an algorithm against a ground truth established by experts.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as #3. The results of the mechanical and biological tests are objective measurements, not subject to expert adjudication.

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 is not applicable. The device is an orbital atherectomy system, a physical interventional medical device, not an AI or diagnostic tool that assists human readers. No MRMC study was conducted or would be relevant for this type of device.

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

This is not applicable. The device is a physical orbital atherectomy system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation of this device is based on established engineering specifications, material science standards, and biological safety standards. For example:

• Biocompatibility: Conformance to ISO standards for biocompatibility, assessed through laboratory tests (cytotoxicity, sensitization, etc.).
• Mechanical Performance: Measurements against predefined engineering specifications for torque, tensile strength, flexibility, etc., derived from industry standards and internal design requirements.
• System Life: Durability testing against a specified number of cycles or operational hours.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical device, not an AI model requiring a training set.

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

This is not applicable for the same reason as #8.

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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.

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