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The TurboHawk Plus directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Plus catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The TurboHawk Plus catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.

The TurboHawk Plus Directional Atherectomy System (TurboHawk Plus Catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and noncalcified lesions located in native peripheral arteries. When treating complex, hard, calcified lesions, pairing the TurboHawk Plus catheter with the SpiderFX embolic protection device mitigates risk of distal embolization that may be generated when heavily calcified plaque breaks down.

The TurboHawk Plus catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. The distal end of the TurboHawk catheter is comprised of a small cutting unit with an inner blade that rotates within a tubular housing. The proximal end of the TurboHawk Plus catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver is a battery-driven, internally powered device, designed to power the TurboHawk Plus directional atherectomy catheter.

The TurboHawk Plus directional atherectomy system has two switches: 1) the main power switch on the cutter driver and 2) the cutter positioning lever (thumb switch) on the TurboHawk Plus catheter. The main power switch on the cutter driver supplies power to the device when turned on. When the thumb switch is pulled proximally to the On position, the TurboHawk Plus catheter activates the drive shaft and the cutter. With the cutter engaged, the TurboHawk Plus 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 Plus catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the TurboHawk Plus catheter thumb switch is fully advanced distally to the Off position, excised tissue is packed into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

This document describes the FDA's 510(k) premarket notification for the TurboHawk Plus Directional Atherectomy System. The provided text does not contain a study comparing AI performance, but rather outlines the performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, focusing on the device performance and acceptance criteria for the TurboHawk Plus Directional Atherectomy System:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the performance tests were conducted using internal Risk Analysis procedures and that "The results from these tests demonstrate that TurboHawk Plus meets the product performance specifications." It does not provide specific numerical acceptance criteria or detailed numerical results for each test. Instead, it broadly asserts that the device meets those specifications.

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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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