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The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).

The Diamondback 360° ™ Orbital Atherectomy System (OAS) is intended for use in treatment of artificial ateriovenous 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 the A-V shunt stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS) is applied to remove neointimal tissue causing a stenosis in the A-V shunt.

Here's an analysis of the provided text regarding the Diamondback 360°™ Orbital Atherectomy System, focusing on acceptance criteria and the supporting study information:

Based on the provided snippets (K071427), it appears this submission is for a premarket notification (510(k)) that relies on substantial equivalence to a predicate device, not on a new clinical study with specific performance acceptance criteria. Therefore, the device performance is demonstrated through comparison to the predicate, and a traditional "study proving the device meets acceptance criteria" as might be seen for devices requiring clinical efficacy data is not explicitly detailed.

Here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) for substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary "performance" shown here is the successful completion of functional, mechanical, and biocompatibility testing, and the conclusion that these, along with similarities in design, materials, and intended use, establish equivalence.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided documents. The submission emphasizes mechanical testing and biocompatibility rather than a clinical human trial.
• Data Provenance: Not applicable in the context of a human clinical test set. The functional and safety testing would have been conducted internally by Cardiovascular Systems, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided as the submission does not detail a clinical study requiring expert-established ground truth. The "ground truth" for functional and safety testing would be based on engineering specifications and recognized standards (like ISO 10993).

4. Adjudication method for the test set

• Not applicable. There is no indication of a clinical test set requiring adjudication in these documents.

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

• Not applicable. This device is an atherectomy system (a physical device for removing plaque), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related metrics are irrelevant here.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the functional and safety testing (mechanical, biocompatibility), the ground truth is based on engineering specifications, standardized test methods (e.g., ISO 10993), and regulatory requirements for medical devices. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth in a clinical study context for this specific 510(k) submission.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As above, no training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this 510(k) context is primarily the pre-clinical functional and safety testing combined with the comparative analysis against the predicate device (K041630).

• Study Design: The submission indicates that "representative samples of the device underwent mechanical testing and biocompatibility in accordance with ISO 10993." This constitutes the primary evidence base presented.
• Purpose: To verify that the device design met its functional and performance requirements and to demonstrate substantial equivalence to the predicate device in terms of principles of operation, technology, materials, and indications for use.
• Conclusion: The sponsor concluded that the Diamondback 360°™ Orbital Atherectomy System is equivalent to the predicate device (K041630) based on these similarities and the successful completion of the pre-clinical testing. The FDA's issuance of the 510(k) clearance signifies agreement with this conclusion, deeming the device as safe and effective as the predicate.

This 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed device – a common pathway for medical device clearance when significant new safety or effectiveness questions are not raised. Clinical efficacy data, detailed human study designs, or AI performance metrics are typically not required for such submissions unless the device introduces new technology or indications that fundamentally alter its risk/benefit profile compared to existing devices.

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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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