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The Phoenix Atherectomy System is in atherectomy of the peripheral vasculature. The system is not intended for use in the 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. The 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. A Wire Support Clip is used to hold the guidewire in a fixed position relative to the Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The Phoenix Tracking Catheter models track directly over the guidewire with no tip deflection capability. The currently marketed models available for clinical use are 1.8mm, 2.2mm, and 2.4mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.

The subject 510(k) submission is proposed to introduce the following modifications:

(i) the predicate 2.2 mm X 130cm Phoenix Deflecting Catheter is being modified to add a new model with a 2.4mm distal cutter assembly to enable debulking to a larger lumen diameter. The 2.4 mm distal cutter assembly is equivalent in design to the currently marketed 2.4mm X 127cm Phoenix Deflecting Catheter.

(ii) the predicate 1.8 mm X 149cm Phoenix Tracking Catheter is being modified to add a 1.5mm tip diameter X 149cm Phoenix Tracking Catheter model to the Phoenix Catheter product family.

This document is a 510(k) premarket notification approval letter for the Phoenix Atherectomy System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets them, particularly regarding the performance of an AI-based system.

The provided text describes a medical device for atherectomy, which is a mechanical procedure to remove plaque from peripheral arteries. The "Testing Summary" section lists various engineering and functional tests (e.g., dimensional inspection, simulated use, torque tests, embolic profile test), but these are related to the physical performance and safety of the atherectomy system itself, not to the performance of an AI system for diagnostics or image analysis.

Therefore, I cannot provide the requested information from this document, as it does not pertain to an AI-based device or a study structured with acceptance criteria, ground truth, and human reader performance data as typically seen in AI/ML medical device submissions.

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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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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 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 multiple models of the Phoenix Catheter. The smaller Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8 mm and 2.2 mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.

This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter Phoenix Catheter models to increase the overall working length from 130 cm to 149 cm and thereby create two new longer-length models within the Phoenix Catheter product family.

The provided document is a 510(k) premarket notification for a medical device (Phoenix® Atherectomy System). These notifications primarily aim to demonstrate substantial equivalence to a predicate device, rather than providing extensive details on novel acceptance criteria and study designs typically found in regulatory submissions for new devices or software.

Based on the provided text, the device is an updated version of an existing device (the only change being an increased working length of the catheter). Therefore, the "acceptance criteria" discussed relate to demonstrating that the modified device performs equivalently to the predicate device, not to establishing new performance benchmarks for a novel device or AI algorithm. The study described is a series of engineering and performance tests rather than a clinical trial or a study assessing human reader performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the traditional sense, nor does it provide quantitative performance metrics for each. Instead, it states that the testing "demonstrate[s] that the performance and technological characteristics of the modified Phoenix Atherectomy System meet defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System."

The technological characteristics of the modified device are compared to the predicate device in Table 9-1. The "acceptance" is implied by the "Identical" assessment for most characteristics, and the successful completion of the listed tests.

The "study" that proves the device meets these criteria consists of the following tests:

• Dimensional and Visual Inspection
• Simulated Use
• Cutter Torque Chain Torque-to-Failure Test
• Functional Outer Shaft Torque Test
• Knob to Shaft Testing
• Catheter Drive Train Stress Test
• Cutter Stall Test
• Temperature Rise of Catheter During Simulated Use
• Kink Bend Radius Test
• Guidewire Compatibility
• Catheter Trackability in Below-the-Knee Anatomy

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data or patient outcomes. The testing described is bench testing and simulated use. Therefore, there is no information on a sample size of patients or data provenance (country of origin, retrospective/prospective). The "samples" would be the catheters themselves used in the engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is not a study involving expert review of medical images or patient data to establish ground truth. The "ground truth" for these engineering tests would be the established design specifications and performance characteristics of the predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this is not a study requiring expert adjudication of clinical outcomes or interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a premarket notification for a mechanical atherectomy system, not an AI software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a premarket notification for a mechanical atherectomy system, not an AI software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the equivalence demonstration is the established performance and specifications of the legally marketed predicate device (K140944 Phoenix Atherectomy System). The objective of the testing was to show that the modified device's performance, despite an increased length, did not deviate in a way that would alter its safety or effectiveness compared to the predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would involve a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device that would involve a "training set."

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