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The Phoenix® Atherectomy System is in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle.

The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. An accessory, the Phoenix Wire Support Clip, is also supplied and can be used to clip a guidewire torque device in a fixed position relative to the Phoenix Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The smaller 1.8mm and 2.2mm Phoenix Catheter models are compatible with 5F and 6F sheaths, respectively, and track directly over the guidewire with no tip deflection capability. The larger 2.4mm Phoenix Catheter is 7F with the tip having deflection capability. All Phoenix Catheter models use the same Phoenix Handle and are compatible with specific commercially available 0.014" exchange length (260 cm or greater) guidewires listed in the product's instructions for use.

This 510(k) includes modifications to the 2.4mm tip diameter Phoenix Deflecting Catheter distal cutter assembly, as well as the Catheter and proximal chassis design to optimize the ease of use, tip deflection capabilities and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate devices.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study proving a device meets them.

The document is a 510(k) premarket notification letter for the Phoenix Atherectomy System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of clinical study results or specific acceptance criteria with performance data.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria and Reported Device Performance: While the document lists various types of testing performed (e.g., "Simulated Use", "Comparative Predicate Testing in Simulated Lesion"), it does not provide specific quantitative acceptance criteria for these tests nor the reported numerical performance of the device against those criteria. For example, it lists "Deflection span (Side-to-side) ≥ 6.0mm" as a characteristic of the modified device, implying this is a performance target, but it doesn't present a table showing the actual measured deflection span from a study.
• Sample Size and Data Provenance (Test Set): The document mentions "Comparative Predicate Testing in Simulated Lesion." However, it does not specify the sample size used for this or any other test. It also does not provide information about data provenance (e.g., country of origin, retrospective/prospective nature).
• Number and Qualifications of Experts for Ground Truth (Test Set): There is no mention of experts being used to establish a ground truth for any test sets. The testing appears to be primarily engineering and bench testing.
• Adjudication Method: Not applicable as no expert-based ground truth establishment is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe any MRMC studies or human-in-the-loop performance evaluations. The device is an atherectomy system, not an AI diagnostic tool that would typically involve such studies.
• Standalone (Algorithm Only) Performance: Not applicable for this type of medical device.
• Type of Ground Truth Used: The ground truth for the various engineering tests would be defined by the specified design requirements or physical measurements, not by expert consensus, pathology, or outcomes data in the traditional sense of AI/diagnostic device validation.
• Sample Size for Training Set: Not applicable as this is not an AI/machine learning device.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for a medical device that details its technological characteristics and the types of non-clinical testing conducted to support its substantial equivalence to a predicate device. It does not contain the detailed clinical study data, acceptance criteria framework, or AI-specific validation information you are requesting.

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