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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.

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