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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 is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from arterial blood vessels within the body. The FreedomFlow™ Orbital Circumferential Atherectomy System is used together with a compatible introducer sheath and 0.014-inch diameter x 300 cm (minimum length) atherectomy guidewire. The driveshaft is introduced into the patient's vasculature by traditional minimally invasive techniques. The FreedomFlow™ User Handle is available in model numbers that are listed below with vessel size ranges.

The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) includes an integrated driveshaft with multiple abrasive spheres on a rotating driveshaft. The abrasive spheres are eccentrically mounted onto the driveshaft so that when the driveshaft is rotated, they move outward due to centrifugal force. These abrasive spheres are spaced along the driveshaft in a spiral configuration to optimize plaque modification within a vessel while still maintaining flexibility for treating tortuous arterial anatomy. The User Handle includes two rotational speeds: low speed at 50,000 revolutions per minute (RPM) and high speed at 76,000 RPM.

The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) is powered by Cardio Flow Power Supply H7001, which is a hospital-grade portable, reusable component. H7001 provides DC power to rotate the FreedomFlow™ driveshaft. H7001 also provides DC power to a saline pump integrated into the FreedomFlow™ User Handle. During operation the saline pump delivers saline to the distal tip of the driveshaft.

The FreedomFlow™ orbital atherectomy User Handle is supplied single patient use, sterile. The package contents include the following items.

• FreedomFlow™ orbital atherectomy User Handle with integrated electric motor and saline pump
• Saline infusion tubing set

I'm sorry, but your request cannot be fulfilled. The provided document is an FDA 510(k) clearance letter for a medical device (FreedomFlow™ Orbital Circumferential Atherectomy System), not for an AI/ML-driven medical device.

The document describes the physical characteristics of an atherectomy system, its intended use, and bench testing to demonstrate its mechanical and performance characteristics (like plaque removal efficiency, tensile strength, rotational speed, etc.). It does not involve any AI/ML components, nor does it describe a study involving human readers, ground truth establishment by experts, or MRMC studies, which are typical for validating AI/ML-driven medical devices.

Therefore, I cannot extract the information required to describe acceptance criteria and a study proving an AI/ML device meets those criteria from this non-AI/ML medical device submission.

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