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

The AtheroMed 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 optional Wire Support Clip can also be used to clip a guidewire torque device in a fixed position relative to the Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System. There are three different models of the Phoenix Catheter. Two Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8mm and 2.2mm tip diameter sizes. A third, 2.4mm tip diameter model has a Catheter tip design that can be deflected and rotated by the user so that the cutter can eccentrically debulk to a larger diameter than the Catheter's 2.4mm distal cutter. The controls for deflection and rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All three Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260cm or greater) guidewires, and all use the same Phoenix Handle. This 510(k) includes modifications to the cutter and distal assembly of the 1.8mm and 2.2mm tip diameter Phoenix Catheter models, as well as modifications to the Catheter and proximal chassis design, to further optimize the device design and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate device. Additionally, the Phoenix Guidewire has been added as a compatible guidewire in the product labeling.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the acceptance criteria implicitly through the various tests conducted and the conclusion that the device "meet defined design requirements" and "performs in a manner equivalent to the predicate Phoenix Atherectomy System." Since this is a 510(k) submission for modifications to an already cleared device, the primary acceptance criterion is substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test. It mentions "Comparative Predicate Testing in Simulated Lesion," implying a test set was used, but the size or characteristics of the "simulated lesion" are not detailed.

The data provenance is from laboratory testing and simulations ("Simulated Use," "Comparative Predicate Testing in Simulated Lesion," "Temperature Rise of Catheter During Simulated Use," "Catheter Trackability in Below-the-Knee Anatomy"). No information is provided about patient data, animal studies, or specific geographic origins. Given the tests listed, the data is likely prospective in nature, as tests were performed specifically to evaluate the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily engineering and bench-top performance evaluations, rather than clinical studies requiring expert interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The evaluations are based on objective engineering measurements and laboratory results, not on subjective interpretations from multiple readers requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. This document describes a 510(k) submission for an atherectomy system, which is a surgical tool, and the testing focuses on its physical and performance characteristics, not on diagnostic accuracy or interpretation by human readers. Therefore, the concept of "improving human readers with AI vs without AI assistance" is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this device. The Phoenix Atherectomy System is a physical medical device (catheter-based system), not an AI algorithm. Its performance is intrinsically tied to human operation during a medical procedure.

7. The Type of Ground Truth Used

The "ground truth" for the various tests appears to be defined by engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, in "Cutter Torque Chain Torque-to-Failure Test" or "Kink Bend Radius Test," the ground truth would be the pre-defined acceptable limits of torque or bend radius. For "Biocompatibility," the ground truth is established by relevant ISO standards or guidelines for material safety.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. Training sets are typically used for machine learning or AI models. This document describes the evaluation of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set in the context of this device's evaluation, this question is not applicable.

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

The AtheroMed 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. The Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectorny Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. An optional Wire Support Clip can also be used to clip a guidewire torque device in a fixed position relative to the Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately, as sterile, single-use components of the Phoenix Atherectomy System.

There are three different models of the Phoenix Catheter. Two Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8mm and 2.2mm tip diameter sizes. A third, 2.4mm tip diameter model has a Catheter tip design that can be deflected and rotated by the user so that the cutter can eccentrically debulk to a larger diameter than the Catheter's 2.4mm distal cutter. The controls for deflection and rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle.

All three Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260cm or greater) guidewires, and all use the same Phoenix Handle.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states that "Both primary endpoints met the predefined IDE study success criteria." However, the specific numerical thresholds for these success criteria are not explicitly stated in the provided text.

Study Information

1. Study Type and Design:

• Study Name: EASE clinical study
• Study Design: Prospective, multi-center, non-randomized, single-arm study.

2. Sample Size Used for the Test Set and Data Provenance:

• Total Patients Enrolled: 128
• Per-Protocol Group: 105 subjects (with 123 treated lesions)
• Data Provenance: Multi-center, prospective study. The country of origin is not explicitly stated, but the submission is to the FDA, implying a US-based or internationally recognized standard, likely including US centers given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Number of Experts: An "independent physician adjudicator" was used to assess the primary safety endpoint. The exact number is not explicitly stated beyond "an" adjudicator, implying one or a group acting as a single entity for this purpose.
• Qualifications: "independent physician adjudicator." Specific medical specialty or years of experience are not provided.
• The primary effectiveness endpoint (acute technical success) was "assessed by the study investigator at the time of treatment." This implies the treating physician or a designated study investigator at each center made this assessment. Their qualifications are not further detailed.

4. Adjudication Method for the Test Set:

• Safety Endpoint: "assessed by an independent physician adjudicator." This implies a form of independent review, though the specific method (e.g., 2+1, 3+1) is not detailed.
• Effectiveness Endpoint: "assessed by the study investigator." This suggests local assessment rather than a centralized adjudication committee for this particular endpoint.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The study described (EASE clinical study) is a single-arm study evaluating the device's performance, not a comparative effectiveness study involving human readers with and without AI assistance. The device in question is an atherectomy system, a physical medical device, not an AI software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

• This question is not applicable as the Phoenix Atherectomy System is a physical medical device, not an algorithm or AI software intended for standalone performance without human interaction. Its design inherently involves human-in-the-loop (the clinician using the device).

7. Type of Ground Truth Used:

• Safety Endpoint: Clinical outcomes for Major Adverse Events (MAE) at 30 days, independently adjudicated.
• Effectiveness Endpoint: Angiographic assessment (quantitative angiography or visual estimate) of residual diameter stenosis <50% at the time of treatment. This is a direct measure based on medical imaging and clinical assessment.

8. Sample Size for the Training Set:

• The provided document describes a clinical study (EASE) for performance evaluation. It does not mention a "training set" in the context of machine learning or AI development. The device itself is a mechanical system, not an AI model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no mention of a training set for an AI model. The device is a mechanical atherectomy system.

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