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The TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

The TurboHawk Peripheral Plaque Excision System (TurboHawk Catheter and ev3 Cutter Driver) is designed for the treatment of de novo and restenotic calcified and non-calcified atherosclerotic lesions located in native peripheral arteries. The TurboHawk Catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a small cutting assembly comprised of a rotating inner cutter contained within a tubular housing. The proximal end of the TurboHawk Catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the ev3 Cutter Driver. The ev3 Cutter Driver is a handheld, disposable, battery-driven unit (Catalog No: 02550) which powers the system.

The TurboHawk Peripheral Plaque Excision System has two switches: 1) the SilverHawk Cutter Driver main power switch and 2) the TurboHawk Catheter thumb switch. The ev3 Cutter Driver main power switch supplies power to the device when turned ON. The TurboHawk Catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the ON position. With the cutter engaged, the TurboHawk Catheter is slowly advanced across the lesion, shaving occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the TurboHawk Catheter thumb switch distally deactivating the drive shaft and disengaging the cutter. The TurboHawk Catheter thumb switch is fully advanced distally to the OFF position in order to pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The provided document focuses on the 510(k) summary for the TurboHawk™ Peripheral Plaque Excision System and its substantial equivalence to predicate devices. It does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Instead, the document details physical and mechanical performance testing for a medical device (atherectomy catheter system) and demonstrates its substantial equivalence to previously cleared devices. Therefore, I cannot extract the requested information for an AI/ML device from this text.

Here's a breakdown of what the document does provide, and why it doesn't align with your request:

• Device Type: This is a physical medical device (atherectomy catheter system), not an AI/ML algorithm or system.
• Performance Testing: The "Performance Testing Summary" lists in vitro tests conducted to demonstrate the device's physical and mechanical characteristics (e.g., effective length, guidewire loading, cutter height, cycle and life, cut depth, cut mass per pass, embolization).
• Acceptance Criteria for the Device: The document states, "Test results met the specified acceptance criteria," but it does not explicitly list the quantitative acceptance criteria for each test. It implies these criteria were internal and part of the substantial equivalence claim.
• Study That Proves the Device Meets Acceptance Criteria: The document refers to "in vitro tests" performed. These tests are physical evaluations of the device's components and functionality, not clinical studies involving human patients or AI/ML model performance.
• No Information on AI/ML Specifics: There is no mention of:
  • AI/ML algorithms
  • Test sets, training sets
  • Data provenance (country of origin, retrospective/prospective)
  • Ground truth establishment (experts, pathology, outcomes data)
  • Adjudication methods
  • MRMC studies or effect sizes of AI assistance
  • Standalone algorithm performance

In summary, the provided text describes the regulatory filing for a conventional medical device, not an AI/ML-powered one. Therefore, it does not contain the information needed to answer your request about acceptance criteria and studies for an AI/ML device.

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