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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

The provided text describes a medical device, the FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere), and its substantial equivalence determination by the FDA. However, the document does not contain the level of detail requested regarding acceptance criteria and the specifics of a study proving a device meets these criteria in the context of an AI/human-in-the-loop system.

The "study" mentioned in this document refers to performance testing for a mechanical medical device, specifically:

• Dimensional Analysis Testing
• Orbit Characterization Testing (effectiveness of sanding technology, lumen diameter vs. speed vs. time, plaque removal efficiency)
• Simulated Life Test
• Torque Stall and Loaded Start Test
• Joint Tensile Test
• Joint Torque Test
• Particulate Analysis Comparison Test
• Electric System Human Cadaver Pre-Clinical Test

There is no indication that this device incorporates AI or sophisticated software that would necessitate human-in-the-loop performance studies, expert ground truth adjudication, or metrics like sensitivity, specificity, or AUC, which are typically associated with AI-powered diagnostic or assistive devices.

Therefore, I cannot provide the requested information in the format of the questions because the document describes a mechanical atherectomy system, not a device whose performance is measured in the ways implied by the prompt's questions (e.g., AI assistance, expert readers, ground truth establishment for AI training/testing).

If the prompt intended for me to infer or create a hypothetical scenario for an AI-powered atherectomy system, I would need additional context or a different document. Based only on the provided text, the questions are not applicable to the described device and its testing.

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