Search Results

The Diamondback 360°™ Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use in treating de novo or restenotic, calcified lesions in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device called the "Diamondback 360° Orbital Atherectomy System."

While it confirms the device's clearance and provides indications for use, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods for ground truth, or types of ground truth used in any studies.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

This document is a regulatory approval letter, not a clinical study report or a technical performance specification document.

Ask a specific question about this device

The Diamondback 360°™ 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 Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

The Diamondback 360°™ Orbital Atherectomy System (OAS) with Sidewinder Shaft is intended for use in the treatment of peripheral artery and A-V shunt stenosis.

OAS provides a method of removing stenotic material from peripheral arteries and A-V shunts. OAS applies a diamond coated, eccentrically rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.

The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:

• 1. Orbital atherectomy device, with biased shaft
• 2. Orbital atherectomy controller, and
• 3. Atherectomy guidewire.

This 510(k) is for the same device with modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency.

The provided document describes a medical device, the Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft, and its clearance process through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full-scale clinical study with defined endpoints.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way envisioned by the prompt. Instead, it focuses on demonstrating safety and effectiveness through comparison to existing, legally marketed devices.

Here's an analysis based on the information available in the provided text, while highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. A 510(k) summary for a substantial equivalence claim typically focuses on comparing new device features to predicate devices and outlining the tests performed to ensure the modifications do not raise new safety or effectiveness concerns. It does not present specific acceptance criteria with corresponding performance data. The document states: "Laboratory and animal tests were performed to support the safety profile of the modification to the Orbital Atherectomy System. No new questions of safety or effectiveness are raised." This is a general conclusion, not a detailed performance report against specific criteria.

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

This information is not available in the provided document. The document mentions "Laboratory and animal tests," but it does not specify the sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective human data).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

This information is not available in the provided document. Ground truth establishment with experts is typically associated with studies evaluating diagnostic or predictive devices, which is not the primary focus of this submission for an atherectomy system that removes stenotic material.

4. Adjudication Method for the Test Set:

This information is not available in the provided document. Adjudication methods are relevant in studies where expert consensus is needed to establish ground truth or resolve discrepancies, which is not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size:

This information is not available in the provided document. MRMC studies are typically used for evaluating the effectiveness of diagnostic tools where multiple human readers interpret cases. This device is an interventional therapeutic tool, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study:

This information is not available in the provided document. The device is a physical, mechanical system (orbital atherectomy system), not a software algorithm that would perform in a standalone manner.

7. Type of Ground Truth Used:

This information is not explicitly stated in the provided document in the context of device performance. For the "Laboratory and animal tests" mentioned, the "ground truth" would likely refer to established physiological or anatomical measures, but these are not detailed.

8. Sample Size for the Training Set:

This information is not available in the provided document. The concept of a "training set" is relevant for machine learning algorithms, which is not applicable to the physical atherectomy device described.

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

This information is not applicable as there is no "training set" for this type of device.

Summary based on the document:

The provided document is a 510(k) summary for the Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft. It states that the device is substantially equivalent to predicate devices (K072748, K071350, K071427). The modifications involved "modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency."

The evidence provided to support this claim of substantial equivalence and safety/effectiveness consisted of:

• "Laboratory and animal tests" to support the "safety profile of the modification."

The conclusion is that "No new questions of safety or effectiveness are raised."

This type of submission relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate, rather than meeting novel acceptance criteria established for a new technology. Therefore, the specific details requested in the prompt regarding acceptance criteria, study design parameters, expert involvement, and ground truth establishment are not typically included or required in a 510(k) summary of this nature and are absent from the provided text.

Ask a specific question about this device

The Diamondback 360°™ 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 Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V grafts).

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

OAS provides a method of removing stenotic material from peripheral arteries and A-V Graft. OAS applies a diamond coated, eccentrically rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.

The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:

1. Orbital Atherectomy Device,
2. Orbital Atherectomy Controller, and
3. Guidewire.

This 510(k) is for the same device with modifications to the orbital atherectomy controller for ergonomics and ease of use.

The provided text is a 510(k) summary for a medical device called the Diamondback 360°™ Orbital Atherectomy System. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices.

However, the document does not contain information about acceptance criteria, specific device performance metrics, or the details of any studies (like sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) typically associated with proving a device meets acceptance criteria.

The 510(k) states: "Laboratory test data were provided to support the safety of the modification to the Diamondback 360°TM Orbital Atherectomy System. No new questions of safety or effectiveness are raised." This implies that some testing was done to support the modification, but the details of those tests, including specific acceptance criteria and performance results, are not included in this summary.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices for a modified version of the same system, rather than presenting detailed clinical or performance study results for this specific 510(k) submission.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The Diamondback 360° Orbital System (OAS) is intended for use in the treatment of peripheral artery stenosis also referred to as Peripheral Artery Disease (PAD). PAD is the result of a stenosis of peripheral arteries, typically in the legs. The OAS provides a method of removing stenotic material from peripheral arteries. The OAS applies a diamond coated, eccentrally rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body. The Diamondback 360° Orbital Atherectomy System consists of the following three significant components: 1) Orbital Atherectomy Device, 2) Guide Wire, and 3) Controller.

The provided document is a 510(k) summary for the Diamondback 360° Orbital Atherectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and studies in the same way a PMA (Pre-Market Approval) submission for a novel device would.

Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, and expert adjudication for an algorithm's performance is not present in this document because the device in question is a physical medical device (an atherectomy system), not an AI/ML algorithm or a diagnostic tool that would typically have such performance metrics.

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or a "reported device performance" in terms of specific numerical thresholds for a device's diagnostic or predictive accuracy. Instead, the "performance" shown is that the device was deemed "substantially equivalent" to predicate devices based on safety and effectiveness.

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

The document mentions "Laboratory animal and clinical data" were provided but does not specify the sample size for the clinical study or the test set (if referring to a dataset for an algorithm, which is not the case here).

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: "Laboratory animal and clinical data." No mention of specific countries of origin or whether the clinical data was retrospective or prospective is present.

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

This information is not applicable to this 510(k) submission as it concerns a physical medical device, not a diagnostic algorithm that requires "ground truth" derived from expert consensus on images or data. Clinical studies for devices like this typically involve assessment of patient outcomes by physicians, but this is different from establishing a diagnostic ground truth for an AI system.

• Number of Experts: Not applicable/not specified for an AI ground truth.
• Qualifications of Experts: Not applicable/not specified for an AI ground truth.

4. Adjudication Method for the Test Set

This is not applicable for a physical atherectomy device. Adjudication methods like 2+1 or 3+1 refer to how multiple expert opinions are combined to establish a ground truth for an AI algorithm's test set.

• Adjudication Method: Not applicable.

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 as the device is an atherectomy system, not a diagnostic AI tool that would assist human readers in interpreting medical images or data.

• MRMC Study: Not applicable.
• Effect Size of AI Assistance: Not applicable.

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

This is not applicable as the device is a physical medical device, not an algorithm.

• Standalone Performance Study: Not applicable.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically discussed for AI algorithms (expert consensus, pathology, outcome data for diagnosis) does not directly apply to the performance evaluation of an atherectomy device in the same way. The studies focused on "safety" and "effectiveness," which would involve clinical endpoints like reduction in stenosis, complication rates (e.g., vessel dissection, distal embolization), and patient outcomes, rather than a diagnostic "ground truth."

• Type of Ground Truth: Clinical endpoints related to safety (e.g., adverse events, complications) and effectiveness (e.g., patency rates, reduction of stenosis), rather than a diagnostic "ground truth."

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."

• Sample Size for Training Set: Not applicable.

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

This is not applicable, as there is no "training set" or "ground truth" in the context of an AI algorithm for this physical device.

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device