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

The TurboHawk Catheter (THS-LS-C, THS-LX-C) is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions.

The SilverHawk and TurboHawk Peripheral Plaque Excision System consists of a Catheter and Cutter Driver, which are packaged separately, but shipped and used together during the plaque excision procedure. The catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the catheter is a small cutting assembly comprised of a rotating inner blade contained within a tubular housing. The proximal end of the Catheter contains a connector and positioning lever designed to fit into a small, disposable, battery driven Cutter Driver, which powers the device.

The SilverHawk and TurboHawk Peripheral Plaque Excision System each have two switches: 1) the Cutter Driver main power switch and 2) the Catheter thumb switch. The Cutter Driver main power switch supplies power to the device when turned ON. When the thumb switch is fully forward (OFF), the cutting blade is closed and stored in the cutter housing with the motor off. This position is used during delivery of the device to the target lesion. Once the device has been positioned the Catheter thumb switch is pulled proximally to the ON position to activate the drive shaft and engage the cutter. Pulling back on the Catheter thumb switch simultaneously turns on the motor and causes the distal portion of the cutter housing to deflect, forcing the device against the target lesion. At the same time, this motion exposes the inner rotating blade, preparing the device for lesion treatment. With the blade spinning, the 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 Catheter thumb switch distally, deactivating the drive shaft, disengaging the cutter, and aligning the cutter and housing. The Catheter thumb switch is fully advanced distally to the OFF position in order to move the cutter forward within the tip and pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The SilverHawk and TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, platinum/iridium, carbide w/ 12% nickel binder, titanium, delrin, polyimide, PET lined tecothane, pebax, nylon, Teflon, tungsten carbide, ABS, PVC, silicone, Santoprene, polycarbonate, polypropylene and hydrophilic coating.

The provided document is a 510(k) summary for the Medtronic SilverHawk and TurboHawk Peripheral Plaque Excision Systems. It describes changes made to the device and the testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested data points related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable or available in this document. The document focuses on performance testing in a bench setting to support a 510(k) clearance.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes "Test Methods Used to Evaluate Change" and concludes that "The results from these tests demonstrate that the technological and performance characteristics of the proposed SilverHawk and TurboHawk devices perform in a manner equivalent to the predicate devices currently on the market."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not explicitly stated for any of the individual bench tests. The document refers to "testing" or "tests" but does not give the number of units or replicates tested.
• Data provenance: Bench testing results. This implies the data was generated in a laboratory or engineering setting, likely within Medtronic. No geographical origin is specified beyond Medtronic Vascular, Inc. is located in Plymouth, MN, USA. The testing is prospective in the sense that it was conducted on the modified devices before market clearance.

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. The "ground truth" for bench testing of a medical device's physical and functional properties is typically defined by engineering specifications, material properties, and comparative performance against predicate devices, not expert human interpretation.

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

Not applicable, as this refers to adjudication for expert consensus in clinical data, which is not present in this document.

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 document describes a 510(k) submission for a peripheral plaque excision system (a physical device for atherectomy), not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable, as this is not an algorithm or AI device. The described tests evaluate the physical device's performance.

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

Not applicable. For this type of device and testing, the "ground truth" is defined by established engineering and material science principles, manufacturing specifications, and the performance characteristics of the predicate devices. The objective is to demonstrate that the modified device performs similarly to or within acceptable limits compared to the original/predicate design.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The TurboHawk® Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk is indicated for use in conjunction with the SpiderFX® Embolic Protection Device in the treatment of severely calcified lesions. The TurboHawk is NOT intended for use in 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 noncalcified atherosclerotic lesions located in native peripheral arteries. When used in complex, hard, calcified lesions, the TurboHawk should be paired with the SpiderFX® Embolic Protection Device to mitigate any risk of distal embolization that may be generated by the breakdown of heavily calcified plaque. 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 which powers the system.

The TurboHawk Peripheral Plaque Excision System has two switches: 1) the ev3 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 TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, polyimide, tecothane, pebax, nylon, delrin, PTFE, tungsten carbide, titanium, platinum/iridium, ABS, PVC, silicone, polypropylene and hydrophilic coating.

The provided text describes the 510(k) summary for the TurboHawk® Peripheral Plaque Excision System. It details the device, its indications for use, comparison to a predicate device, and performance testing, including a clinical summary.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The primary safety and effectiveness endpoints were derived from historical registry data using plaque excision," but it does not explicitly list the specific numerical acceptance thresholds for these endpoints. The table above presents the achieved performance, implying these met the pre-determined, but unquantified, acceptance criteria.

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

• Test Set Sample Size: 133 subjects. The document also states 163 lesions for the Angiographic Core Laboratory assessment and 167 lesions for the site assessment of the primary effectiveness endpoint.
• Data Provenance: Prospective, multi-center study ("DEFINITIVE Cat+"). The country of origin is not explicitly stated, but the context implies data from the United States, given the FDA regulatory submission. The study enrolled subjects from 17 centers.

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

• Number of Experts: Not explicitly stated as a number of individual experts.
• Qualifications of Experts: The ground truth for safety and effectiveness endpoints was established through an "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC)." While specific individual qualifications (e.g., "Radiologist with 10 years of experience") are not provided, these are standard bodies in clinical trials, implying qualified medical professionals (e.g., interventional radiologists, cardiologists) with expertise in reviewing angiograms and clinical events. Their independence is highlighted.

4. Adjudication Method for the Test Set

• The document explicitly states that the "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC) were employed to ensure unbiased review and classification of events and endpoints." This indicates a formal adjudication process was in place. While a specific "2+1" or "3+1" method is not detailed, the mention of "adjudication" by these committees suggests a consensus or formal review process for discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. This study focuses on the performance of the device itself, with outcomes assessed by human experts (Core Lab, CEC). The device is an atherectomy system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• No, a standalone algorithm performance study was not done. The device is a physical medical device (atherectomy system), not a software algorithm. The "performance testing" referenced (e.g., biocompatibility, cycle and life, tissue removal) are all related to the physical device's function.

7. The Type of Ground Truth Used

• The ground truth used was based on expert consensus/adjudication by an "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC)" for both safety (30-day freedom from MAE) and effectiveness (residual diameter stenosis) endpoints.

8. The Sample Size for the Training Set

• The document does not mention a training set or its sample size. This is a medical device 510(k) submission, not an AI/algorithm development submission that would typically involve distinct training and test sets in the same manner. The "predicate device" (K093301) and the data supporting its clearance could be considered analogous to a "training" or "prior experience" in device safety and effectiveness, but it's not a formal dataset used to train an algorithm.

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

• As a training set is not explicitly referred to in the context of algorithm development, this question is not applicable. The device's design and performance are related to engineering principles and prior iterations of the device (K093301). The "ground truth" for the device's acceptable performance, more broadly, is established through various performance tests (bench and in-vivo) whose results "met the specified acceptance criteria" (refer to Section 7).

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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 SilverHawk™ 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 SilverHawk Cutter Driver. The SilverHawk 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 SilverHawk 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 describes the TurboHawk™ Peripheral Plaque Excision System. It is a 510(k) summary for a medical device rather than a study report for an AI/ML device. Therefore, the detailed information about acceptance criteria, study design, expert qualifications, and AI-specific performance metrics (like effect size with AI assistance or standalone algorithm performance) is not applicable or present in this document.

However, based on the information provided, here's what can be extracted and inferred within the context of a medical device submission:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in a table format for specific performance metrics. Instead, it states that "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence."

The reported device performance is broadly summarized as:

• Performance data: "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
• Conclusion regarding substantial equivalence: "Based on the identical indications for use, similar technological characteristics, materials and operating principle, and the results from safety and performance testing, the TurboHawk Peripheral Plaque Excision System is considered substantially equivalent to the SilverHawk Peripheral Plaque Excision System (K061188)."

Without specific individual test results and their predefined acceptance values, a detailed table cannot be created.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Bench testing and biocompatibility testing." These types of tests typically do not involve human subject data or clinical trials in the way an AI/ML study would. Therefore, concepts like "test set," "sample size," and "data provenance" related to patient data are not directly applicable here. For bench testing, the "sample size" would refer to the number of devices or components tested, and "provenance" would relate to the manufacturing batch or lot of those samples. This specific information is not provided.

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)

This information is not applicable. The device is a physical medical instrument (an atherectomy catheter system), not an AI/ML diagnostic tool requiring expert-established ground truth on medical images or patient data. Bench testing and biocompatibility testing involve laboratory measurements and assessments against engineering specifications and biological safety standards, not expert medical opinions on patient cases.

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

Not applicable, as this refers to adjudication of expert opinions, which is not part of the evaluation for this type of device submission.

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 device is a physical atherectomy system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable, as the device is not an algorithm.

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

For this type of device, the "ground truth" for evaluating its performance would typically involve:

• Engineering specifications: The device is designed to meet certain physical and mechanical properties.
• Material standards: Biocompatibility is assessed against established standards for material safety.
• Functional performance criteria: Bench testing would verify functions like cutting ability, tissue capture, guidewire trackability, and power system operation against predetermined, measurable criteria.
• Predicate device performance: Substantial equivalence relies on demonstrating that the new device performs similarly to a legally marketed predicate device (SilverHawk™ Peripheral Plaque Excision System in this case) under comparable test conditions.

The document states that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." This implies the "ground truth" was compliance with established engineering, material, and functional performance benchmarks rather than expert medical diagnoses.

8. The sample size for the training set

Not applicable. This device does not involve machine learning; therefore, there is no "training set."

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

Not applicable, as there is no training set for this device.

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